72 Subpart G—Gums, Chewing Gum Bases and Related Substances

Food and Drug Administration, HHS Pt. 172

409(c)(2) of the Act), a regulation pre- § 171.130 Procedure for amending and scribing the conditions under which repealing tolerances or exemptions the food additive may be safely used from tolerances. (including, but not limited to, speci- (a) The Commissioner, on his own fications as to the particular food or initiative or on the petition of any in- classes of food in or on which such ad- terested person, pursuant to part 10 of ditive may be used, the maximum this chapter, may propose the issuance quantity that may be used or per- of a regulation amending or repealing a mitted to remain in or on such food, regulation pertaining to a food additive the manner in which such additive may or granting or repealing an exception be added to or used in or on such food, for such additive. and any directions or other labeling or (b) Any such petition shall include an packaging requirements for such addi- assertion of facts, supported by data, tive deemed necessary by him to assure showing that new information exists the safety of such use), and prior to the with respect to the food additive or that new uses have been developed or forwarding of the order to the FEDERAL old uses abandoned, that new data are REGISTER for publication shall notify available as to toxicity of the chem- the petitioner of such order and the ical, or that experience with the exist- reasons for such action; or by order ing regulation or exemption may jus- deny the petition, and shall notify the tify its amendment or repeal. New data petitioner of such order and of the rea- shall be furnished in the form specified sons for such action. in §§ 171.1 and 171.100 for submitting pe- (b) The regulation shall describe the titions. conditions under which the substance [42 FR 14491, Mar. 15, 1977, as amended at 42 may be safely used in any meat prod- FR 15674, Mar. 22, 1977] uct, meat food product, or poultry product subject to the Federal Meat In- PART 172—FOOD ADDITIVES PER- spection Act (FMIA) (21 U.S.C. 601 et seq.) or the Poultry Products Inspec- MITTED FOR DIRECT ADDITION TO tion Act (PPIA) (21 U.S.C. 451 et seq.). FOOD FOR HUMAN CONSUMP- (c) If the Commissioner determines TION that additional time is needed to study Subpart A—General Provisions and investigate the petition, he shall by written notice to the petitioner ex- Sec. tend the 90-day period for not more 172.5 General provisions for direct food ad- than 180 days after the filing of the pe- ditives. tition. Subpart B—Food Preservatives [42 FR 14489, Mar. 15, 1977, as amended at 65 172.105 Anoxomer. FR 51763, Aug. 25, 2000] 172.110 BHA. 172.115 BHT. § 171.102 Effective date of regulation. 172.120 Calcium disodium EDTA. A regulation published in accordance 172.130 Dehydroacetic acid. 172.133 Dimethyl dicarbonate. with § 171.100(a) shall become effective 172.135 Disodium EDTA. upon publication in the FEDERAL REG- 172.140 Ethoxyquin. ISTER. 172.145 Heptylparaben. 172.150 4-Hydroxymethyl-2,6-di-tert-butyl- § 171.110 Procedure for objections and phenol. hearings. 172.155 Natamycin (pimaricin). 172.160 Potassium nitrate. Objections and hearings relating to 172.165 Quaternary ammonium chloride food additive regulations under section combination. 409 (c), (d), or (h) of the Act shall be 172.167 Silver nitrate and hydrogen peroxide governed by part 12 of this chapter. solution. 172.170 Sodium nitrate. [42 FR 14491, Mar. 15, 1977, as amended at 42 172.175 Sodium nitrite. FR 15674, Mar. 22, 1977] 172.177 Sodium nitrite used in processing smoked chub. 172.180 Stannous chloride.

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172.185 TBHQ. 172.575 Quinine. 172.190 THBP. 172.580 Safrole-free extract of sassafras. 172.585 Sugar beet extract flavor base. Subpart C—Coatings, Films and Related 172.590 Yeast-malt sprout extract. Substances Subpart G—Gums, Chewing Gum Bases 172.210 Coatings on fresh citrus fruit. and Related Substances 172.215 Coumarone-indene resin. 172.225 Methyl and ethyl esters of fatty 172.610 Arabinogalactan. acids produced from edible fats and oils. 172.615 Chewing gum base. 172.230 Microcapsules for flavoring sub- 172.620 Carrageenan. stances. 172.623 Carrageenan with polysorbate 80. 172.235 Morpholine. 172.626 Salts of carrageenan. 172.250 Petroleum naphtha. 172.655 Furcelleran. 172.255 Polyacrylamide. 172.660 Salts of furcelleran. 172.260 Oxidized polyethylene. 172.665 Gellan gum. 172.270 Sulfated butyl oleate. 172.695 Xanthan gum. 172.275 Synthetic paraffin and succinic derivatives. Subpart H—Other Specific Usage Additives 172.280 Terpene resin. 172.710 Adjuvants for pesticide use dilu- Subpart D—Special Dietary and Nutritional tions. Additives 172.712 1,3-Butylene glycol. 172.715 Calcium lignosulfonate. 172.310 Aluminum nicotinate. 172.720 Calcium lactobionate. 172.315 Nicotinamide-ascorbic acid complex. 172.723 Epoxidized soybean oil. 172.320 Amino acids. 172.725 Gibberellic acid and its potassium 172.325 Bakers yeast protein. salt. 172.330 Calcium pantothenate, calcium chlo- 172.730 Potassium bromate. ride double salt. 172.735 Glycerol ester of rosin. 172.335 D-Pantothenamide. 172.736 Glycerides and polyglycides of hy- 172.340 Fish protein isolate. drogenated vegetable oils. 172.345 Folic acid (folacin). 172.755 Stearyl monoglyceridyl citrate. 172.350 Fumaric acid and salts of fumaric 172.765 Succistearin (stearoyl propylene gly- acid. col hydrogen succinate). 172.365 Kelp. 172.770 Ethylene oxide polymer. 172.370 Iron-choline citrate complex. 172.775 Methacrylic acid-divinylbenzene co- 172.372 N-Acetyl-L-methionine. polymer. 172.375 Potassium iodide. 172.780 Acacia (gum arabic). 172.379 Vitamin D2. 172.785 Listeria-specific bacteriophage prepa- 172.380 Vitamin D3. ration. 172.381 Vitamin D2 bakers yeast. 172.385 Whole fish protein concentrate. Subpart I—Multipurpose Additives 172.395 Xylitol. 172.399 Zinc methionine sulfate. 172.800 Acesulfame potassium. 172.802 Acetone peroxides. Subpart E—Anticaking Agents 172.803 Advantame. 172.804 Aspartame. 172.410 Calcium silicate. 172.806 Azodicarbonamide. 172.430 Iron ammonium citrate. 172.808 Copolymer condensates of ethylene 172.480 Silicon dioxide. oxide and propylene oxide. 172.490 Yellow prussiate of soda. 172.809 Curdlan. 172.810 Dioctyl sodium sulfosuccinate. Subpart F—Flavoring Agents and Related 172.811 Glyceryl tristearate. Substances 172.812 Glycine. 172.814 Hydroxylated lecithin. 172.510 Natural flavoring substances and 172.816 Methyl glucoside-coconut oil ester. natural substances used in conjunction 172.818 Oxystearin. with flavors. 172.820 Polyethylene gylcol (mean molec- 172.515 Synthetic flavoring substances and ular weight 200-9,500). adjuvants. 172.822 Sodium lauryl sulfate. 172.520 Cocoa with dioctyl sodium sulfo- 172.824 Sodium mono- and dimethyl naph- succinate for manufacturing. thalene sulfonates. 172.530 Disodium guanylate. 172.826 Sodium stearyl fumarate. 172.535 Disodium inosinate. 172.828 Acetylated monoglycerides. 172.540 DL-Alanine. 172.829 Neotame. 172.560 Modified hop extract. 172.830 Succinylated monoglycerides.

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172.831 Sucralose. Subpart A—General Provisions 172.832 Monoglyceride citrate. 172.833 Sucrose acetate isobutyrate (SAIB). § 172.5 General provisions for direct 172.834 Ethoxylated mono- and diglycerides. food additives. 172.836 Polysorbate 60. (a) Regulations prescribing condi- 172.838 Polysorbate 65. 172.840 Polysorbate 80. tions under which food additive sub- 172.841 Polydextrose. stances may be safely used predicate 172.842 Sorbitan monostearate. usage under conditions of good manu- 172.844 Calcium stearoyl-2-lactylate. facturing practice. For the purposes of 172.846 Sodium stearoyl lactylate. this part, good manufacturing practice 172.848 Lactylic esters of fatty acids. shall be defined to include the fol- 172.850 Lactylated fatty acid esters of glyc- lowing restrictions. erol and propylene glycol. (1) The quantity of the substance 172.852 Glyceryl-lacto esters of fatty acids. added to food does not exceed the 172.854 Polyglycerol esters of fatty acids. amount reasonably required to accom- 172.856 Propylene glycol mono- and diesters plish its intended physical, nutritive, of fats and fatty acids. or other technical effect in food. 172.858 Propylene glycol alginate. (2) Any substance intended for use in 172.859 Sucrose fatty acid esters. or on food is of appropriate food grade 172.860 Fatty acids. and is prepared and handled as a food 172.861 Cocoa butter substitute from coco- ingredient. nut oil, palm kernel oil, or both oils. (b) The existence of a regulation pre- 172.862 Oleic acid derived from tall oil fatty acids. scribing safe conditions of use for a 172.863 Salts of fatty acids. food additive shall not be construed to 172.864 Synthetic fatty alcohols. relieve the use of the substance from 172.866 Synthetic glycerin produced by the compliance with any other provision of hydrogenolysis of carbohydrates. the Act. 172.867 Olestra. (c) The existence of any regulation 172.868 Ethyl cellulose. prescribing safe conditions of use for a 172.869 Sucrose oligoesters. nutrient substance does not constitute 172.870 Hydroxypropyl cellulose. a finding that the substance is useful 172.872 Methyl ethyl cellulose. or required as a supplement to the diet 172.874 Hydroxypropyl methylcellulose. of humans. 172.876 Castor oil. 172.878 White mineral oil. Subpart B—Food Preservatives 172.880 Petrolatum. 172.882 Synthetic isoparaffinic petroleum § 172.105 Anoxomer. hydrocarbons. 172.884 Odorless light petroleum hydro- Anoxomer as identified in this sec- carbons. tion may be safely used in accordance 172.886 Petroleum wax. with the following conditions: 172.888 Synthetic petroleum wax. (a) Anoxomer is 1,4-benzenediol, 2- 172.890 Rice bran wax. (1,1-dimethylethyl)-polymer with 172.892 Food starch-modified. diethenylbenzene, 4-(1,1-dimethyl- 172.894 Modified cottonseed products in- ethyl)phenol, 4- methoxyphenol, 4,4′-(1- tended for human consumption. methylethylidene)bis(phenol) and 4- 172.896 Dried yeasts. methylphenol (CAS Reg. No. 60837–57–2) 172.898 Bakers yeast glycan. prepared by condensation polymeriza- AUTHORITY: 21 U.S.C. 321, 341, 342, 348, 371, tion of divinylbenzene (m- and p-) with 379e. tert-butylhydroquinone, tert-butylphenol, hydroxyanisole, p-cresol and SOURCE: 42 FR 14491, Mar. 15, 1977, unless ′ otherwise noted. 4,4 -isopropylidenediphenol. (b) The polymeric antioxidant meets EDITORIAL NOTE: Nomenclature changes to the following specifications: part 172 appear at 61 FR 14482, Apr. 2, 1996, 66 (1) Polymer, not less than 98.0 per- FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, 2001, 68 FR 15355, Mar. 31, 2003, 70 FR 40880, cent as determined by an ultraviolet July 15, 2005, 70 FR 67651, Nov. 8, 2005, 70 FR method entitled ‘‘Ultraviolet Assay, 72074, Dec. 1, 2005, and 81 FR 49896, July 29, ‘‘1982, which is incorporated by ref- 2016. erence. Copies are available from the

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Center for Food Safety and Applied Nu- § 172.110 BHA. trition (HFS–200), Food and Drug Ad- The food additive BHA (butylated hy- ministration, 5001 Campus Dr., College droxyanisole) alone or in combination Park, MD 20740, or at the National Ar- with other antioxidants permitted in chives and Records Administration food for human consumption in this (NARA). For information on the avail- subpart B may be safely used in or on ability of this material at NARA, call specified foods, as follows: 202–741–6030, or go to: http:// (a) The BHA meets the following www.archives.gov/federallregister/ specification: codeloflfederallregulations/ ibrllocations.html. Assay (total BHA), 98.5 percent minimum. ° (2) Molecular weight: Total mono- Melting point 48 C minimum. mers, dimers and trimers below 500 not (b) The BHA is used alone or in com- more than 1 percent as determined by a bination with BHT, as an antioxidant method entitled ‘‘Low Molecular in foods, as follows: Weight Anoxomer Analysis,’’ 1982, Limitations which is incorporated by reference. (total BHA Copies are available from the Center Food and BHT) parts per for Food Safety and Applied Nutrition million (HFS–200), Food and Drug Administra- tion, 5001 Campus Dr., College Park, Dehydrated potato shreds ...... 50 MD 20740, or at the National Archives Active dry yeast ...... 1 1,000 Beverages and desserts prepared from dry and Records Administration (NARA). mixes ...... 1 2 For information on the availability of Dry breakfast cereals ...... 50 this material at NARA, call 202–741– Dry diced glazed fruit ...... 1 32 6030, or go to: http://www.archives.gov/ Dry mixes for beverages and desserts ...... 1 90 Emulsion stabilizers for shortenings ...... 200 federallregister/ Potato flakes ...... 50 codeloflfederallregulations/ Potato granules ...... 10 ibrllocations.html. Sweet potato flakes ...... 50 (3) Phenol content: Not less than 3.2 1 BHA only. milliequivalent/gram and not more than 3.8 milliequivalent/gram as deter- (c) To assure safe use of the additive: mined by a method entitled ‘‘Total (1) The label of any market package Phenols,’’ 1982, which is incorporated of the additive shall bear, in addition by reference. Copies are available from to the other information required by the Center for Food Safety and Applied the Act, the name of the additive. Nutrition (HFS–200), Food and Drug (2) When the additive is marketed in Administration, 5001 Campus Dr., Col- a suitable carrier, in addition to meet- lege Park, MD 20740, or at the National ing the requirement of paragraph (c)(1) of this section, the label shall declare Archives and Records Administration the percentage of the additive in the (NARA). For information on the avail- mixture. ability of this material at NARA, call (3) The label or labeling of dry mixes 202–741–6030, or go to: http:// for beverages and desserts shall bear www.archives.gov/federallregister/ adequate directions for use to provide codeloflfederallregulations/ that beverages and desserts prepared ibrllocations.html. from the dry mixes contain no more (4) Heavy metals as lead (as Pb), not than 2 parts per million BHA. more than 10 parts per million. Arsenic (as As), not more than 3 parts per mil- § 172.115 BHT. lion. Mercury (as Hg), not more than 1 The food additive BHT (butylated hy- part per million. droxytoluene), alone or in combination (c) Anoxomer may be safely used as with other antioxidants permitted in an antioxidant in food at a level of not this subpart B may be safely used in or more than 5,000 parts per million based on specified foods, as follows: on fat and oil content of the food. (a) The BHT meets the following [48 FR 18798, Apr. 26, 1983, as amended at 54 specification: Assay (total BHT) 99 per- FR 24896, June 12, 1989] cent minimum.

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(b) The BHT is used alone or in com- Limita- bination with BHA, as an antioxidant tion Food (parts Use in foods, as follows: per million) Limitations (total BHA Dressings, nonstandard- 75 Preservative. Food and BHT) ized. parts per Dried lima beans 310 Promote color retention. million (cooked canned). Egg product that is 1 200 Preservative. Dehydrated potato shreds ...... 50 hard-cooked and con- Dry breakfast cereals ...... 50 sists, in a cylindrical Emulsion stabilizers for shortenings ...... 200 shape, of egg white Potato flakes ...... 50 with an inner core of Potato granules ...... 10 egg yolk. Sweetpotato flakes ...... 50 Fermented malt bev- 25 Antigushing agent. erages. (c) To assure safe use of the additive: French dressing ...... 75 Preservative. Legumes (all cooked 365 Promote color retention. (1) The label of any market package canned, other than of the additive shall bear, in addition dried lima beans, pink to the other information required by beans, and red the Act, the name of the additive. beans). Mayonnaise ...... 75 Do. (2) When the additive is marketed in Mushrooms (cooked 200 Promote color retention. a suitable carrier, in addition to meet- canned). ing the requirement of paragraph (c)(1) Oleomargarine ...... 75 Preservative. Pecan pie filling ...... 100 Promote color retention. of this section, the label shall declare Pink beans (cooked 165 Promote color retention. the percentage of the additive in the canned). mixture. Potato salad ...... 100 Preservative. Processed dry pinto 800 Promote color retention. beans. § 172.120 Calcium disodium EDTA. Red beans (cooked 165 Promote color retention. The food additive calcium disodium canned). Salad dressing ...... 75 Preservative. EDTA (calcium disodium ethylene- Sandwich spread ...... 100 Do. diaminetetraacetate) may be safely Sauces ...... 75 Do. used in designated foods for the pur- Shrimp (cooked 250 Retard struvite forma- canned). tion; promote color poses and in accordance with the condi- retention. tions prescribed, as follows: Spice extractives in 60 Promote color and fla- (a) The additive contains a minimum soluble carriers. vor retention. of 99 percent by weight of either the di- Spreads, artificially col- 100 Promote color retention. ored and lemon-fla- hydrate C10H12O8N2CaNa2·2H2O or the vored or orange-fla- trihydrate C10H12O8N2CaNa2·3H2O, or vored. any mixture of the two. 1 By weight of egg yolk portion. (b) It is used or intended for use as (2) With disodium EDTA (disodium follows: ethylenediaminetetraacetate) in the (1) Alone, in the following foods at following foods at not to exceed, in not to exceed the levels prescribed, cal- combination, the levels prescribed, calculated as the anhydrous compound: culated as anhydrous C10H12O8N2CaNa2: Limita- tion Limita- Food (parts Use tion per mil- Food (parts Use lion) per million) Cabbage, pickled ...... 220 Promote color, flavor, and texture retention. Dressings, nonstandardized .... 75 Preservative. French dressing ...... 75 Do. Canned carbonated soft 33 Promote flavor reten- Mayonnaise ...... 75 Do. drinks. tion. Salad dressing ...... 75 Do. Canned white potatoes 110 Promote color retention. Sandwich spread ...... 100 Do. Clams (cooked canned) 340 Promote color retention. Sauces ...... 75 Do. Crabmeat (cooked 275 Retard struvite forma- canned). tion; promote color retention. (c) To assure safe use of the additive: Cucumbers pickled ...... 220 Promote color, flavor, (1) The label and labeling of the addi- and texture retention. tive container shall bear, in addition to Distilled alcoholic bev- 25 Promote stability of erages. color, flavor, and/or the other information required by the product clarity. Act, the name of the additive.

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(2) The label or labeling of the addi- 25-mL Pipette tive container shall bear adequate use 10-mL Burette (automatic, eg., Metrohm bu- directions to provide a final food prod- rette) uct that complies with the limitations Stirrer provided in paragraph (b) of this sec- Device for potentiometric titration tion. Reference electrode (d) In the standardized foods listed in Glass electrode paragraph (b) of this section, the addi- REAGENTS tives are used only in compliance with the applicable standards of identity for Acetone, analytical-grade such foods. Solution of 1 N diisobutylamine in chloro- benzene, distilled [42 FR 14491, Mar. 15, 1977, as amended at 48 1 N Acetic Acid FR 10815, Mar. 15, 1983; 58 FR 52222, Oct. 7, 1993; 60 FR 33710, June 29, 1995; 65 FR 48379, PROCEDURE Aug. 8, 2000] Accurately weigh in about 2 grams of the § 172.130 Dehydroacetic acid. sample (W) and dissolve in 100 mL acetone. Add accurately 25 mL of the 1 N diisobutyl- The food additive dehydroacetic acid amine solution by pipette and allow to stand and/or its sodium salt may be safely for 5 minutes. Subsequently, titrate the re- used in accordance with the following action mixture potentiometrically with 1 N prescribed conditions: hydrochloric acid (consumption=a mL) while (a) The food additive meets the fol- stirring. For determining the blank con- lowing specifications: sumption, carry out the analysis without a sample (consumption=b mL). Dehydroacetic acid: Melting point, 109 °C–111 ° C; assay, minimum 98 percent (dry basis). CALCULATION Sodium salt of dehydroacetic acid: Assay, minimum 98 percent (dry basis). ()ba− ×13. 4 (b) It is used or intended for use as a = % DMDC preservative for cut or peeled squash, W and is so used that no more than 65 NOTE: For adding the diisobutylamine so- parts per million expressed as dehydro- lution, always use the same pipette and wait acetic acid remains in or on the pre- for a further three drops to fall when the pared squash. flow has stopped. (c) The label or labeling of any pack- (2) The additive contains not more age of the additive intended for use in than 2,000 ppm (0.2 percent) dimethyl food shall bear adequate directions for carbonate as determined by a method use to insure compliance with this sec- entitled ‘‘Gas Chromatography Method tion. for Dimethyl Carbonate Impurity in § 172.133 Dimethyl dicarbonate. Dimethyl Dicarbonate,’’ which is incorporated by reference in accordance Dimethyl dicarbonate (CAS Reg. No. with 5 U.S.C. 552(a). Copies are avail- 4525–33–1) may be safely used in food in accordance with the following pre- able from the Center for Food Safety scribed conditions: and Applied Nutrition (HFS–200), 5001 (a) The additive meets the following Campus Dr., College Park, MD 20740, or specifications: at the National Archives and Records (1) The additive has a purity of not Administration (NARA). For informa- less than 99.8 percent as determined by tion on the availability of this mate- the following titration method: rial at NARA, call 202–741–6030, or go to: http://www.archives.gov/ PRINCIPLES OF METHOD federallregister/ Dimethyl dicarbonate (DMDC) is mixed codeloflfederallregulations/ with excess diisobutylamine with which it ibrllocations.html. reacts quantitatively. The excess amine is backtitrated with acid. (b) The additive is used or intended for use as a microbial control agent in APPARATUS the following beverages under normal 250-milliliter (mL) Beaker circumstances of bottling, canning, or 100-mL Graduate cylinder other forms of final packaging, where

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the viable microbial load has been re- culated as anhydrous calcium disodium duced to 500 microorganisms per milli- EDTA: liter or less by current good manufac- Limita- turing practices such as heat treat- tion ment, filtration, or other technologies Food (parts Use per mil- prior to the use of dimethyl dicar- lion) bonate: (1) In wine, dealcoholized wine, and Aqueous multivitamin prep- 150 With iron salts as a arations. stabilizer for vita- low alcohol wine in an amount not to min B 12 in liquid exceed 200 parts per million. multivitamin prep- (2) In ready-to-drink teas in an arations. amount not to exceed 250 parts per mil- Canned black-eyed peas .... 145 Promote color retention. lion. Canned kidney beans ...... 165 Preservative. (3) In carbonated or noncarbonated, Canned strawberry pie filling 500 Promote color re- nonjuice-containing (less than or equal tention. to 1 percent juice), flavored or Cooked sausage ...... 36 As a cure accel- erator with so- unflavored beverages containing added dium ascorbate electrolytes (5–20 milliequivalents/liter or ascorbic acid. sodium ion (Na + ) and 3–7 milli- Dressings, nonstandardized 75 Preservative. equivalents/liter potassium ion (K + )) French dressing ...... 75 Do. Frozen white potatoes in- 100 Promote color re- in an amount not to exceed 250 parts cluding cut potatoes. tention. per million. Gefilte fish balls or patties in 1 50 Inhibit discoloration. (4) In carbonated, dilute beverages packing medium. Legumes (all cooked 165 Promote color re- containing juice, fruit flavor, or both, canned, other than black- tention. with juice content not to exceed 50 per- eyed peas). cent, in an amount not to exceed 250 Mayonnaise ...... 75 Preservative. parts per million. Ready-to-eat cereal prod- 2 315 Promote color re- ucts containing dried ba- tention. (c) To ensure the safe use of the food nanas. additive, the label of the package con- Salad dressing ...... 75 Preservative. taining the additive shall bear, in addi- Sandwich spread ...... 100 Do. tion to other information required by Sauces ...... 75 Do. the Federal Food, Drug, and Cosmetic 1 Based on total weight of finished product including packing Act: medium. 2 In dried banana component of cereal product. (1) The name of the additive ‘‘dimethyl dicarbonate.’’ (2) With calcium disodium EDTA (2) The intended use of the additive. (calcium disodium ethylenediamine- (3) Adequate directions for use to en- tetraacetate; calcium disodium sure compliance with this section. (ethylenedinitrilo) tetraacetate), in the following foods at not to exceed, in [53 FR 41329, Oct. 21, 1988, as amended at 58 combination, the levels prescribed, cal- FR 6091, Jan. 26, 1993; 59 FR 5319, Feb. 4, 1994; culated as anhydrous C10H12O8N2CaNa2: 61 FR 14245, Apr. 1, 1996; 61 FR 26788, May 29, 1996; 66 FR 13653, Mar. 7, 2001] Limita- tion Food (parts Use § 172.135 Disodium EDTA. per mil- The food additive disodium EDTA lion) (disodium ethylenediaminetetraace- Dressings, nonstandardized 75 Preservative. tate) may be safely used in designated French dressing ...... 75 Do. foods for the purposes and in accord- Mayonnaise ...... 75 Do. ance with the following prescribed con- Salad dressing ...... 75 Do. Sandwich spread ...... 100 Do. ditions: Sauces ...... 75 Do. (a) The additive contains a minimum of 99 percent disodium ethylenedia- (3) Alone, as a sequestrant in the minetetraacetate dihydrate nonnutritive sweeteners that are listed (C10H14O8N2Na2·2H2O). in § 180.37 of this chapter and that, in (b) It is used or intended for use as addition, are designed for aqueous solu- follows: tion: Provided, That the amount of the (1) Alone, in the following foods at additive, calculated as anhydrous cal- not to exceed the levels prescribed, calcium disodium EDTA, does not exceed

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0.1 percent by weight of the dry non- section 401 of the Act (21 U.S.C. 341) do nutritive sweetener. not preclude such use. (c) To assure the safe use of the additive: § 172.150 4-Hydroxymethyl-2,6-di-tert- (1) The label and labeling of the addi- butylphenol. tive container shall bear, in addition to The food additive 4-hydroxymethyl- the other information required by the 2,6-di-tert-butylphenol may be safely act, the name of the additive. used in food in accordance with the fol- (2) The label or labeling of the addi- lowing prescribed conditions: tive container shall bear adequate use (a) The additive has a solidification directions to provide a final food prod- point of 140 °C–141 °C. uct that complies with the limitations (b) The additive is used as an anti- provided in paragraph (b) of this sec- oxidant alone or in combination with tion. other permitted antioxidants. (d) In the standardized foods listed in (c) The total amount of all anti- paragraphs (b) (1) and (2) of this section oxidants added to such food shall not the additives are used only in compli- exceed 0.02 percent of the oil or fat con- ance with the applicable standards of tent of the food, including the essential identity for such foods. (volatile) oil content of the food. [42 FR 14491, Mar. 15, 1977, as amended at 65 § 172.155 Natamycin (pimaricin). FR 48379, Aug. 8, 2000] (a) Natamycin (CAS Reg. No. 7681–93– § 172.140 Ethoxyquin. 8), also known as pimaricin, is a pol- yene macrolide antimycotic substance (a) Ethoxyquin (1,2-dihydro-6-ethoxy- possessing an empirical formula of 2,2,4-trimethylquinoline) may be safely C33H47NO13 and a molecular weight of used as an antioxidant for preservation 665.7. of color in the production of chili pow- (b) The additive shall conform to the der, paprika, and ground chili at levels following specifications: not in excess of 100 parts per million. (b) In order to provide for the safe Purity: 97 percent ±2 percent on an anhy- use of the additive in feed prepared in drous basis. accordance with §§ 573.380 and 573.400 of Arsenic: Not more than 1 part per million. Heavy metals (as Pb): Not more than 20 parts this chapter, tolerances are established per million. for residues of ethoxyquin in or on edible products of animals as follows: (c) The additive may be applied on cheese, as an antimycotic, in amounts 5 parts per million in or on the uncooked fat not to exceed 20 milligrams per kilo- of meat from animals except poultry. gram (20 parts per million) in the fin- 3 parts per million in or on the uncooked liver and fat of poultry. ished product as determined by Inter- 0.5 part per million in or on the uncooked national Dairy Federation (IDF) Stand- muscle meat of animals. ard 140A:1992, ‘‘Cheese and Cheese 0.5 part per million in poultry eggs. Rind-Determination of Natamycin Con- Zero in milk. tent-Method by Molecular Absorption Spectrometry and by High-Perform- § 172.145 Heptylparaben. ance Liquid Chromatography,’’ which (a) The food additive heptylparaben is incorporated by reference. The Di- is the chemical n-heptyl p-hydroxy- rector of the Office of the Federal Reg- benzoate. ister approves this incorporation by (b) It may be safely used to inhibit reference in accordance with 5 U.S.C. microbiological spoilage in accordance 552(a) and 1 CFR part 51. Copies are with the following prescribed condi- available from the Division of Product tions: Policy (HFS–206), Center for Food Safe- (1) In fermented malt beverages in ty and Applied Nutrition, Food and amounts not to exceed 12 parts per mil- Drug Administration, 5001 Campus Dr., lion. College Park, MD 20740, or may be ex- (2) In noncarbonated soft drinks and amined at the Food and Drug Adminis- fruit-based beverages in amounts not tration’s Main Library, 10903 New to exceed 20 parts per million, when Hampshire Ave., Bldg. 2, Third Floor, standards of identity established under Silver Spring, MD 20993, 301–796–2039, or

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at the National Archives and Records Component Parts per Administration (NARA). For informa- million tion on the availability of this mate- n-Hexadecyl dimethyl benzyl ammonium chlo- rial at NARA, call 202–741–6030, or go ride ...... 1.5–6.0 to: http://www.archives.gov/ n-Octadecyl dimethyl benzyl ammonium chlo- federallregister/ ride ...... 0.25–1.0 n-Tetradecyl dimethyl benzyl ammonium chlo- codeloflfederallregulations/ ride ...... 3.0–12.0 ibrllocations.html. n-Tetradecyl dimethyl ethylbenzyl ammonium chloride ...... 1.6–6.5 [47 FR 26823, June 22, 1982, as amended at 50 FR 49536, Dec. 3, 1985; 63 FR 66015, Dec. 1, 1998; 66 FR 13847, Mar. 8, 2001; 81 FR 5591, Feb. [50 FR 3890, Jan. 29, 1985] 3, 2016] § 172.167 Silver nitrate and hydrogen § 172.160 Potassium nitrate. peroxide solution. The food additive potassium nitrate An aqueous solution containing a may be safely used as a curing agent in mixture of silver nitrate and hydrogen the processing of cod roe, in an amount peroxide may be safely used in accord- not to exceed 200 parts per million of ance with the following prescribed con- the finished roe. ditions: (a) The additive is used as an anti- § 172.165 Quaternary ammonium chlo- microbial agent in bottled water. ride combination. (b) Hydrogen peroxide meets the The food additive, quaternary ammo- specifications of the Food Chemicals nium chloride combination, may be Codex, 7th ed. (2010), pp. 496–497, which safely used in food in accordance with is incorporated by reference. The Di- the following conditions: rector of the Office of the Federal Reg- (a) The additive contains the fol- ister approves this incorporation by lowing compounds: n-dodecyl dimethyl reference in accordance with 5 U.S.C. benzyl ammonium chloride (CAS Reg. 552(a) and 1 CFR part 51. You may ob- No. 139–07–1); n-dodecyl dimethyl ethyl- tain copies from the United States benzyl ammonium chloride (CAS Reg. Pharmacopeial Convention, 12601 No. 27479–28–3); n-hexadecyl dimethyl Twinbrook Pkwy., Rockville, MD 20852 benzyl ammonium chloride (CAS Reg. (Internet address http://www.usp.org). No. 122–18–9); n-octadecyl dimethyl Copies may be examined at the Food benzyl ammonium chloride (CAS Reg. and Drug Administration’s Main Li- No. 122–19–0); n-tetradecyl dimethyl brary, 10903 New Hampshire Ave., Bldg. benzyl ammonium chloride (CAS Reg. 2, Third Floor, Silver Spring, MD 20993, No. 139–08–2); n-tetradecyl dimethyl 301–796–2039, or at the National Ar- ethylbenzyl ammonium chloride (CAS chives and Records Administration Reg. No. 27479–29–4). (NARA). For information on the avail- (b) The additive meets the following ability of this material at NARA, call specifications: pH (5 percent active so- 202–741–6030 or go to: http:// lution) 7.0–8.0; total amines, maximum www.archives.gov/federal-register/cfr/ibr- 1 percent as combined free amines and locations.html. amine hydrochlorides. (c) The amount of silver added will (c) The additive is used as an anti- not exceed 17 micrograms per kilogram microbial agent, as defined in in the treated bottled water, and the § 170.3(o)(2) of this chapter, in raw sugar amount of hydrogen peroxide will not cane juice. It is added prior to clari- exceed 23 milligrams per kilogram in fication when further processing of the the treated bottled water. Analyses for sugar cane juice must be delayed. silver and hydrogen peroxide shall be (d) The additive is applied to the conducted on samples of treated bot- sugar juice in the following quantities, tled water at the site of bottling, using based on the weight of the raw cane: samples of the water intended for treatment for the blank determination. Parts per Component million (d)(1) The amount of silver in the treated bottled water is determined n-Dodecyl dimethyl benzyl ammonium chloride 0.25–1.0 n-Dodecyl dimethyl ethylbenzyl ammonium using the method for silver designated chloride ...... 3.4–13.5 in 21 CFR 165.110(b)(4)(iii)(G)(2)(i).

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(2) The amount of hydrogen peroxide that the level of sodium nitrate does in the treated bottled water is deter- not exceed 500 parts per million and the mined using a Hydrogen Peroxide Test level of sodium nitrite does not exceed Kit from the HACH Co., or equivalent. 200 parts per million in the finished The manual from the Hydrogen Per- product. oxide Test Kit, Model HYP–1, Catalog (2) As a preservative and color fixa- Number 22917–00, 1991, is incorporated tive, with or without sodium nitrite, in by reference. The Director of the Fed- meat-curing preparations for the home eral Register approves this incorpora- curing of meat and meat products (in- tion by reference in accordance with 5 cluding poultry and wild game), with U.S.C. 552(a) and 1 CFR part 51. You directions for use which limit the may obtain copies of the test kit man- amount of sodium nitrate to not more ual from the HACH Co., P.O. Box 389, than 500 parts per million in the fin- Loveland CO, 80359 (1–800–227–4224), ished meat product and the amount of Model HYP–1, Catalog Number 22917–00. sodium nitrite to not more than 200 Copies may be examined at the Food parts per million in the finished meat and Drug Administration’s Main Li- product. brary, 10903 New Hampshire Ave., Bldg. (b) To assure safe use of the additive, 2, Third Floor, Silver Spring, MD 20993, in addition to the other information re- 301–796–2039, 301–436–2163, or at the Na- quired by the Act: tional Archives and Records Adminis- (1) The label of the additive or of a tration (NARA). For information on mixture containing the additive shall the availability of this material at bear: NARA, call 202–741–6030 or go to: http:// (i) The name of the additive. www.archives.gov/federallregister/ (ii) A statement of the concentration codeloflfederallregulations/ of the additive in any mixture. ibrllocations.html. (2) If in a retail package intended for (e) Substances generally recognized household use, the label and labeling of as safe in or on food may be used to the additive, or of a mixture con- stabilize the additive to ensure that taining the additive, shall bear ade- the additive will perform its intended quate directions for use to provide a technical effect. final food product that complies with (f) The additive may not be added to the limitations prescribed in paragraph bottled water that has been filtered or (a) of this section. is intended to be filtered through a sil- (3) If in a retail package intended for ver-containing water filter. household use, the label of the additive (g) Bottled water must meet the or of a mixture containing the addi- quality standards for bottled water in tive, shall bear the statement ‘‘Keep § 165.110(b)(2) through (b)(5) of this out of the reach of children’’. chapter, including the limits specified for total silver and nitrate, unless the § 172.175 Sodium nitrite. water bears a label statement of sub- The food additive sodium nitrite may standard quality, as provided for under be safely used in or on specified foods § 165.110(c) of this chapter. in accordance with the following pre- [74 FR 11478, Mar. 18, 2009, as amended at 78 scribed conditions: FR 71461, Nov. 29, 2013; 81 FR 5591, Feb. 3, (a) It is used or intended for use as 2016] follows: (1) As a color fixative in smoked § 172.170 Sodium nitrate. cured tunafish products so that the The food additive sodium nitrate level of sodium nitrite does not exceed may be safely used in or on specified 10 parts per million (0.001 percent) in foods in accordance with the following the finished product. prescribed conditions: (2) As a preservative and color fixa- (a) It is used or intended for use as tive, with or without sodium nitrate, follows: in smoked, cured sablefish, smoked, (1) As a preservative and color fixa- cured salmon, and smoked, cured shad tive, with or without sodium nitrite, in so that the level of sodium nitrite does smoked, cured sablefish, smoked, cured not exceed 200 parts per million and the salmon, and smoked, cured shad, so level of sodium nitrate does not exceed

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500 parts per million in the finished of the edible portion of the finished product. smoked product is not less than 100 (3) As a preservative and color fixa- parts per million and not greater than tive, with sodium nitrate, in meat-cur- 200 parts per million, as measured in ing preparations for the home curing of the loin muscle. meat and meat products (including (c) Smoked chub shall be heated by a poultry and wild game), with directions controlled heat process which provides for use which limit the amount of so- a monitoring system positioned in as dium nitrite to not more than 200 parts many strategic locations in the smoke- per million in the finished meat prod- house as necessary to assure a contin- uct, and the amount of sodium nitrate uous temperature throughout each fish to not more than 500 parts per million of at least 160 °F for a minimum of 30 in the finished meat product. minutes. (b) To assure safe use of the additive, (d) The finished product shall be in addition to the other information re- cooled to a temperature of 50 °F or quired by the Act: below within 3 hours after smoking and (1) The label of the additive or of a further cooled to a temperature of 38 °F mixture containing the additive shall or below within 12 hours after smoking. bear: A temperature of 38 °F or below shall (i) The name of the additive. be maintained during all subsequent (ii) A statement of the concentration storage and distribution. All shipping of the additive in any mixture. containers, retail packages, and ship- (2) If in a retail package intended for ping records shall indicate with appro- household use, the label and labeling of priate notice the perishable nature of the additive, or of a mixture con- the product and specify that the prod- taining the additive, shall bear ade- uct shall be held under refrigeration (38 quate directions for use to provide a °F or below) until consumed. final food product which complies with (e) To assure safe use of the additive: the limitations prescribed in paragraph (1) The label and labeling of the addi- (a) of this section. tive container shall bear, in addition to (3) If in a retail package intended for the other information required by the household use, the label of the addi- Act, the name of the additive. tive, or of a mixture containing the ad- (2) The label or labeling of the addi- ditive, shall bear the statement ‘‘Keep tive container shall bear adequate di- out of the reach of children’’. rections to assure use in compliance with the provisions of this section. § 172.177 Sodium nitrite used in processing smoked chub. § 172.180 Stannous chloride. The food additive sodium nitrite may The food additive stannous chloride be safely used in combination with salt may be safely used for color retention (NaCl) to aid in inhibiting the out- in asparagus packed in glass, with lids growth and toxin formation from Clos- lined with an inert material, in an tridium botulinum type E in the com- amount not to exceed 20 parts per mil- mercial processing of smoked chub in lion calculated as tin (Sn). accordance with the following prescribed conditions: § 172.185 TBHQ. (a) All fish in smoking establish- The food additive TBHQ, which is the ments shall be clean and wholesome chemical 2-(1,1-dimethylethyl)-1,4-benz- and shall be expeditiously processed, enediol (Chemical Abstracts Service packed, and stored under adequate san- Registry Number 1948–33–0), also known itary conditions in accordance with as tertiary butylhydroquinone, may be good manufacturing practice. safely used in food in accordance with (b) The brining procedure is con- the following prescribed conditions: trolled in such a manner that the (a) The food additive has a melting water phase portion of the edible por- point of not less than 126.5 °C. tion of the finished smoked product has (b) The percentage of TBHQ in the a salt (NaCl) content of not less than food additive is not less than 99.0 per- 3.5 percent, as measured in the loin cent when tested by the assay de- muscle, and the sodium nitrite content scribed in the Food Chemicals Codex,

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9th ed. (2014), pp. 1192–1194, which is in- used in food in accordance with the fol- corporated by reference, or an equiva- lowing prescribed conditions: lent method. The Director of the Office (a) The food additive has a melting of the Federal Register approves this point of 149 °C–153 °C. incorporation by reference in accord- (b) It is used as an antioxidant alone ance with 5 U.S.C. 552(a) and 1 CFR or in combination with other permitted part 51. You may obtain copies from antioxidants. the United States Pharmacopeial Con- (c) The total antioxidant content of a vention, 12601 Twinbrook Pkwy., Rock- ville, MD 20852 (Internet address: http:// food containing the additive will not www.usp.org). Copies may be examined exceed 0.02 percent of the oil or fat con- at the Food and Drug Administration’s tent of the food, including the essential Main Library, 10903 New Hampshire (volatile) oil content of the food. Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the Subpart C—Coatings, Films and National Archives and Records Admin- Related Substances istration (NARA). For information on the availability of this material at § 172.210 Coatings on fresh citrus fruit. NARA, call 202–741–6030 or go to: http:// www.archives.gov/federal-register/cfr/ibr- Coatings may be applied to fresh cit- locations.html. rus fruit for protection of the fruit in (c) It is used as an antioxidant alone accordance with the following condi- or in combination with BHA and/or tions: BHT. (a) The coating is applied in the min- (d) The total antioxidant content of a imum amount required to accomplish food containing the additive will not the intended effect. exceed 0.02 percent of the oil or fat con- (b) The coating may be formulated tent of the food, including the essential from the following components, each (volatile) oil content of the food. used in the minimum quantity required [42 FR 14491, Mar. 15, 1977, as amended at 80 to accomplish the intended effect: FR 34276, June 16, 2015] (1) Substances generally recognized as safe for the purpose or previously § 172.190 THBP. sanctioned for the purpose. The food additive THBP (2,4,5-tri- (2) One or more of the following: hydroxybutyrophenone) may be safely

Component Limitations

Fatty acids ...... Complying with § 172.860. Oleic acid derived from tall oil fatty acids ...... Complying with § 172.862. Partially hydrogenated rosin ...... Catalytically hydrogenated to a maximum refractive index of 1.5012 at 100 °C. Color of WG or paler. Pentaerythritol ester of maleic anhydride-modi- Acid number of 134–145; drop-softening point of 127 °C–173 °C; saponifica- fied wood rosin. tion number of less than 280; and a color of M or paler. Do ...... Acid number of 176–186; drop-softening point of 110 °C–118 °C; saponification number of less than 280; and a color of M or paler. Polyethylene glycol ...... Complying with § 172.820. As a defoamer and dispersing adjuvant. Polyhydric alcohol diesters of oxidatively refined Complying with § 178.3770 of this chapter and having a dropping point of 77 (Gersthofen process) montan wax acids. to 83 °C (170.6 to 181.4 °F), as determined by ASTM Method D566–76 (Reapproved 1982), ‘‘Standard Test Method for Dropping Point of Lubri- cating Grease,’’ which is incorporated by reference (Copies are available from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or at the National Ar- chives 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.) using as a solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene-ethyl alcohol in a 2:1 ratio. Sodium lauryl sulfate ...... Complying with § 172.822. As a film former. Wood rosin ...... Color of K or paler.

(3) In lieu of the components listed in the following copolymer and one or paragraph (b) (2) and (4) of this section, more of the listed adjuvants.

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Component Limitations

Vinyl chloride-vinylidene chloride copolymer ...... As an aqueous dispersion containing a minimum of 75 percent water when applied. Polyethylene glycol ...... Complying with § 172.820. As a defoamer and dispersing adjuvant. Polyvinylpyrrolidone ...... As an adjuvant. Potassium persulfate ...... Do. Propylene glycol alginate ...... Do. Sodium decylbenzenesulfonate ...... Do.

(4) In lieu of the components listed in the following rosin derivative and ei- paragraph (b) (2) and (3) of this section, ther or both of the listed adjuvants:

Component Limitations

Calcium salt of partially dimerized rosin ...... Having a maximum drop-softening point of 197 °C and a color of H or paler. It is prepared by reaction with not more than 7 parts hydrated lime per 100 parts of partially dimerized rosin. The partially dimerized rosin is rosin that has been dimerized by sulfuric acid catalyst to a drop-softening point of 95 °C to 105 °C and a color of WG or paler. Petroleum naphtha ...... As adjuvant. Complying with § 172.250. Sperm oil ...... As adjuvant.

[42 FR 14491, Mar. 15, 1977; 49 FR 5747, Feb. 15, 1984, as amended at 51 FR 2693, Jan. 21, 1986; 52 FR 18911, May 20, 1987; 61 FR 14245, Apr. 1, 1996]

§ 172.215 Coumarone-indene resin. federallregister/ codeloflfederallregulations/ The food additive coumarone-indene ibrllocations.html. resin may be safely used on grapefruit, 25 lemons, limes, oranges, tangelos, and (2) Refractive index (n /D) 1.63–1.64. tangerines in accordance with the fol- (c) It is used or intended for use as a lowing prescribed conditions: protective coating for grapefruit, lem- (a) The food additive is manufactured ons, limes, oranges, tangelos, and tan- by the polymerization of a crude, gerines whereby the maximum amount heavy coal-tar solvent naphtha meet- of the resin remaining on the fruit does ing the following specifications: not exceed 200 parts per million on a fresh-weight basis. (1) It is a mixture of indene, indan (hydrindene), substituted benzenes, and (d) To assure safe use of the additive: related compounds. (1) The label of the market package (2) It contains no more than 0.25 per- or any intermediate premix of the ad- cent tar bases. ditive shall bear, in addition to the (3) 95 percent distills in the range 167 other information required by the act: °C–184 °C. (i) The name of the additive, cou- (b) The food additive meets the fol- marone-indene resin. lowing specifications: (ii) A statement of the concentration (1) Softening point, ring and ball: 126 of the additive therein. °C minimum as determined by ASTM (2) The label or accompanying label- method E28–67 (Reapproved 1982), ing shall bear adequate directions that, ‘‘Standard Test Method for Softening if followed, will result in a finished Point by Ring-and-Ball Apparatus,’’ food not in conflict with the require- which is incorporated by reference. ments of this section. Copies may be obtained from the Amer- [42 FR 14491, Mar. 15, 1977, as amended at 49 ican Society for Testing Materials, 100 FR 10103, Mar. 19, 1984] Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be § 172.225 Methyl and ethyl esters of examined at the National Archives and fatty acids produced from edible Records Administration (NARA). For fats and oils. information on the availability of this Methyl esters and ethyl esters of material at NARA, call 202–741–6030, or fatty acids produced from edible fats go to: http://www.archives.gov/ and oils may be safely used in food,

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subject to the following prescribed con- (4) In lieu of the components listed in ditions: paragraphs (a)(2) and (3) of this section, (a) The additive consists of a mixture the following component: of either methyl or ethyl esters of fatty acids produced from edible fats COMPONENT AND LIMITATIONS and oils and meets the following speci- Petroleum wax—Complying with § 172.886. fications: Not to exceed 50 percent by combined (1) Not less than 90 percent methyl or weight of the microcapsule and spice-fla- ethyl esters of fatty acids. voring substance. (2) Not more than 1.5 percent unsa- (b) The microcapsules produced from ponifiable matter. the components listed in paragraphs (a) (b) The additive is used or intended (1), (2), and (3) of this section may be for use at the level not to exceed 3 per- used for encapsulating authorized fla- cent by weight in an aqueous emulsion voring oils for use, in accordance with in dehydrating grapes to produce rai- good manufacturing practice, in foods sins, whereby the residue of the addi- for which standards of identity estab- tive on the raisins does not exceed 200 lished under section 401 of the Act do parts per million. not preclude such use, except that [57 FR 12711, Apr. 13, 1992] microcapsules formulated from components listed in paragraph (a)(2) of this § 172.230 Microcapsules for flavoring section may be used only for encap- substances. sulating lemon oil, distilled lime oil, orange oil, peppermint oil, and spear- Microcapsules may be safely used for mint oil for use in dry mixes for pud- encapsulating discrete particles of fla- dings and gelatin desserts. voring substances that are generally (c) The microcapsules produced from recognized as safe for their intended the components listed in paragraphs (a) use or are regulated under this part, in (1) and (4) of this section may be used accordance with the following condi- only for encapsulating authorized tions: spice-flavoring substances for use, in (a) The microcapsules may be formu- accordance with good manufacturing lated from the following components, practice, in frozen pizzas which are to each used in the minimum quantity re- be further processed by heat. Such piz- quired to accomplish the intended ef- zas shall bear labels or labeling includ- fect: ing adequate directions for use to en- (1) Substances generally recognized sure heating to temperatures which as safe for the purpose. will melt the wax to release the spice- (2) One or more of the following com- flavoring substances. ponents: [45 FR 48123, July 18, 1980] COMPONENT AND LIMITATIONS § 172.235 Morpholine. Succinylated gelatin—Not to exceed 15 percent by combined weight of the microcap- Morpholine may be safely used as a sule and flavoring oil. Succinic acid con- component of food, subject to the fol- tent of the gelatin is 4.5 to 5.5 percent. lowing restrictions. Arabinogalactan—Complying with § 172.610; (a) It is used as the salt(s) of one or as adjuvant. more of the fatty acids meeting the re- Silicon dioxide—Complying with § 172.480; as quirements of § 172.860, as a component adjuvant. of protective coatings applied to fresh (3) In lieu of the components listed in fruits and vegetables. paragraph (a)(2) of this section, the fol- (b) It is used at a level not in excess lowing components: of that reasonably required to produce its intended effect. COMPONENT AND LIMITATIONS § 172.250 Petroleum naphtha. Glutaraldehyde—As cross-linking agent for insolubilizing a coacervate of gum arabic Petroleum naphtha may be safely and gelatin. used in food in accordance with the fol- n-Octyl alcohol—As a defoamer. lowing conditions:

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(a) The additive is a mixture of liquid ±0.005 centimeter. With distilled water in the hydrocarbons, essentially paraffinic cells, determine any absorbance difference. and naphthenic in nature obtained Spectrophotometer. Spectral range 250–400 μ μ from petroleum, m with spectral slit width of 2 m or less; under instrument operating conditions for (b) The additive is refined to meet these absorbance measurements, the spectro- the following specifications when sub- photometer shall also meet the following jected to the procedures described in performance requirements: this paragraph. ± ° ° Absorbance repeatability, 0.01 at 0.4 absorb- (1) Boiling-point range: 175 F–300 F. ance. (2) Nonvolatile residue: 0.002 gram Absorbance accuracy, 1 ±0.05 at 0.4 absorb- per 100 milliliters maximum. ance. (3) Ultraviolet absorbance limits, as Wavelength repeatability, ±0.2 millimicron. follows: Wavelength accuracy, ±1.0 millimicron. Ultraviolet lamp. Long wavelength (3400– Maximum absorb- 3800A°). Wavelength (milli-microns) ance per centimeter REAGENTS optical pathlength Isooctane (2,2,4-trimethylpentane). Use 180 milliliters in a 250-milliliter Erlenmeyer 280–289 ...... 0.15 flask, add 1 milliliter of purified n-hexa- 290–299 ...... 13 300–359 ...... 08 decane, insert the head assembly, allow ni- 360–400 ...... 02 trogen gas to flow into the inlet tube and connect the outlet tube to a solvent trap and vacuum line in such a way as to prevent any ANALYTICAL SPECIFICATION FOR PETROLEUM back flow of condensate into the flask. The NAPHTHA contents of the flask are evaporated on a GENERAL INSTRUCTIONS steam bath until 1 milliliter of residue remains. Dissolve the 1 milliliter of hexa- All glassware should be scrupulously decane residue in isooctane and make up to cleaned to remove all organic matter such as 25 milliliters. Determine the absorbance in a oil, grease, detergent residues, etc. Examine 5-centimeter path length cell compared to all glassware, including stoppers and stop- isooctane as reference. The absorbance cocks, under ultraviolet light to detect any should not exceed 0.01 per centimeter path residual fluorescent contamination. As a pre- length between 280–400 mμ. If necessary, iso- cautionary measure, it is recommended prac- octane may be purified by passage through a tice to rinse all glassware with purified iso- column of activated silica gel (Grade 12, Da- octane immediately before use. No grease is vidson Chemical Co., Baltimore, Md., or to be used on stopcocks or joints. Great care equivalent) or by distillation. to avoid contamination of petroleum naph- Methyl alcohol, A.C.S. reagent grade. Use 10 tha samples in handling and to assure ab- milliliters and proceed as with isooctane. sence of any extraneous material arising The absorbance per centimeter of path from inadequate packaging is essential. Be- μ cause some of the polynuclear hydrocarbons length should be 0.00 between 280–400 m . sought in this test are very susceptible to Methyl alcohol may be purified by simple photo-oxidation, the entire procedure is to be carried out under subdued light. 1 As determined by procedure using potassium chromate for reference standard and APPARATUS described in National Bureau of Standards Separatory funnels. 250-milliliter, and 2,000- Circular 484, Spectrophotometry, U.S. De- milliliter capacity, equipped with tetra- partment of Commerce, (1949). The accuracy fluoroethylene polymer stopcocks. is to be determined by comparison with the Erlenmeyer flask. 125-milliliter with 24/40 standard values at 290, 345, and 400 milli- standard taper neck. microns. The procedure is incorporated by Evaporation flask. 250-milliliter capacity reference. Copies of the material incor- all-glass flask equipped with 24/40 standard porated by reference are available from the taper stopper having inlet and outlet tubes Center for Food Safety and Applied Nutri- to permit passage of nitrogen across the sur- tion (HFS–200), Food and Drug Administra- face of the container liquid to be evaporated. tion, 5001 Campus Dr., College Park, MD Condenser. 24/40 joints, fitted with drying 20740, or available for inspection at the Na- tube, length optional. tional Archives and Records Administration Spectrophotometric cells. Fused quartz cells, (NARA). For information on the availability optical path length in the range of 5,000 cen- of this material at NARA, call 202–741–6030, timeters ±0.005 centimeter; also for checking or go to: http://www.archives.gov/ spectrophotometer performance only, optical federallregister/codeloflfederallregulations/ path length in the range 1,000 centimeter ibrllocations.html.

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distillation or by refluxing in the presence of tion of the layers, draw off the aqueous layer potassium hydroxide (10 grams/2 liters) and into a second 250-milliliter separatory fun- zinc dust (25 grams/2 liters) for 3 hours fol- nel. Transfer the hydrocarbon layer in the lowed by distillation. first funnel to a 25-milliliter volumetric n-Hexadecane, 99 percent olefin-free. Dilute flask. 1.0 milliliter of n-hexadecane to 25 milliliters Carefully wash the Erlenmeyer flask with with isooctane and determine the absorbance an additional 6 milliliters of isooctane, swirl, in a 5-centimeter cell compared to isooctane and transfer to the second separatory funnel. as reference between 280–400 mμ. The absorb- Shake the funnel for 1 minute. After separa- ance per centimeter path length shall not ex- tion of the layers, draw off the aqueous layer ceed 0.00 in this range. Purify, if necessary, into the first separatory funnel. Transfer the by percolation through activated silica gel isooctane in the second funnel to the volu- or by distillation. metric flask. Again wash the Erlenmeyer Sodium borohydride. 98 percent. flask with an additional 6 milliliters of iso- Water. All distilled water must be ex- octane, swirl, and transfer to the first sepa- tracted with isooctane before use. A series of ratory funnel. Shake the funnel for 1 minute. three successive extracts of 1.5 liters of dis- After separation of the layers, draw off the tilled water with 100-milliliter portions of aqueous layer and discard. Transfer the iso- isooctane is satisfactory. octane layer to the volumetric flask and adjust the volume to 25 milliliters of isooctane. PROCEDURE Mix the contents well, then transfer to the Determination of ultraviolet absorbance. Add first separatory funnel and wash twice with a 25-milliliter aliquot of the hydrocarbon 50-milliliter portions of distilled water. Dis- solvent together with 1 milliliter of hexa- card the aqueous layers after each wash. decane to the 125-milliliter Erlenmeyer Determine the ultraviolet absorbance of flask. While flushing with nitrogen, evapo- the isooctane extract in 5-centimeter path rate to 1 milliliter on a steam bath. Nitrogen length cells compared to isooctane as ref- is admitted through a 8±1-milliliter outer-di- erence between 280–400 mμ. Determine a rea- ameter tube, drawn out into a 2±1-centimeter gent blank concurrently with the sample, long and 1±0.5-millimeter inner-diameter using 25 milliliters of purified isooctane in- capillary tip. This is positioned so that the stead of a solvent sample and measuring the capillary tip extends 4 centimeters into the ultraviolet absorbance of the blank between flask. The nitrogen flow rate is such that the 280–400mμ. surface of the liquid is barely disturbed. The reagent blank absorbance should not After the volume is reduced to that of the 1 exceed 0.04 per centimeter path length be- milliliter of hexadecane, the flask is left on tween 280–289 mμ; 0.020 between 290–359 mμ; the steam bath for 10 more minutes before and 0.010 between 360–400 mμ. removing. Add 10 milliliters of purified iso- Determination of boiling-point range. Use octane to the flask and reevaporate the solu- ASTM method D86–82, ‘‘Standard Method for tion to a 1-milliliter volume in the same Distillation of Petroleum Products,’’ which manner as described above, except do not is incorporated by reference. Copies may be heat for an added 10 minutes. Repeat this op- obtained from the American Society for eration twice more. Let the flask cool. Testing Materials, 100 Barr Harbor Dr., West Add 10 milliliters of methyl alcohol and Conshohocken, Philadelphia, PA 19428-2959, about 0.3 gram of sodium borohydride. (Mini- or may be examined at the National Ar- mize exposure of the borohydride to the at- chives and Records Administration (NARA). mosphere; a measuring dipper may be used.) For information on the availability of this Immediately fit a water-cooled condenser material at NARA, call 202–741–6030, or go to: equipped with a 24/40 joint and with a drying http://www.archives.gov/federallregister/ tube into the flask, mix until the sodium codeloflfederallregulations/ borohydride is dissolved, and allow to stand ibrllocations.html. for 30 minutes at room temperature, with Determination of nonvolatile residue. For hy- intermittent swirling. At the end of this drocarbons boiling below 121 °C, determine time, disconnect the flask and evaporate the the nonvolatile residue by ASTM method methyl alcohol on the steam bath under ni- D1353–78, ‘‘Standard Test Method for Non- trogen until sodium borohydride begins to volatile Matter in Volatile Solvents for Use drop out of solution. Remove the flask and in Paint, Varnish, Lacquer, and Related let it cool. Products;’’ for those boiling above 121 °C, use Add 6 milliliters of isooctane to the flask ASTM method D381–80, ‘‘Standard Test and swirl to wash the crystalline slurry. Method for Existent Gum in Fuels by Jet Carefully transfer the isooctane extract to a Evaporation,’’ which methods are incor- 250-milliliter separatory funnel. Dissolve the porated by reference. Copies may be obtained crystals in the flask with about 25 milliliters from the American Society for Testing Ma- of distilled water and pour this also into the terials, 100 Barr Harbor Dr., West separatory funnel. Adjust the water volume Conshohocken, Philadelphia, PA 19428-2959, in the separatory funnel to about 100 milli- or may be examined at the National Ar- liters and shake for 1 minute. After separa- chives and Records Administration (NARA).

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For information on the availability of this apple, plantain, pumpkin, rutabaga, material at NARA, call 202–741–6030, or go to: squash (acorn), sweetpotatoes, tan- http://www.archives.gov/federallregister/ gerines, turnips, watermelon, Brazil codeloflfederallregulations/ nuts, chestnuts, filberts, hazelnuts, pe- ibrllocations.html. cans, and walnuts (all nuts in shells). (c) Petroleum naphtha containing (c) The additive is used in accordance antioxidants shall meet the specified with good manufacturing practice and ultraviolet absorbance limits after cor- in an amount not to exceed that re- rection for any absorbance due to the quired to produce the intended effect. antioxidants. Petroleum naphtha may contain antioxidants authorized for use § 172.270 Sulfated butyl oleate. in food in an amount not to exceed Sulfate butyl oleate may be safely that reasonably required to accomplish used in food, subject to the following the intended effect or to exceed any prescribed conditions: prescribed limitations. (d) Petroleum naphtha is used or in- (a) The additive is prepared by sul- tended for use as a solvent in protec- fation, using concentrated sulfuric tive coatings on fresh citrus fruit in acid, of a mixture of butyl esters pro- compliance with § 172.210. duced by transesterification of an edible vegetable oil using 1-butanol. Fol- [42 FR 14491, Mar. 15, 1977, as amended at 47 lowing sulfation, the reaction mixture FR 11835, Mar. 19, 1982; 49 FR 10104, Mar. 19, is washed with water and neutralized 1984; 54 FR 24896, June 12, 1989] with aqueous sodium or potassium hy- § 172.255 Polyacrylamide. droxide. Prior to sulfation, the butyl oleate reaction mixture meets the fol- Polyacrylamide containing not more lowing specifications: than 0.2 percent of acrylamide mon- (1) Not less than 90 percent butyl ole- omer may be safely used as a film ate. former in the imprinting of soft-shell (2) Not more than 1.5 percent unsa- gelatin capsules when the amount used ponifiable matter. is not in excess of the minimum re- (b) The additive is used or intended quired to produce the intended effect. for use at a level not to exceed 2 per- § 172.260 Oxidized polyethylene. cent by weight in an aqueous emulsion in dehydrating grapes to produce rai- Oxidized polyethylene may be safely sins, whereby the residue of the addi- used as a component of food, subject to tive on the raisins does not exceed 100 the following restrictions: parts per million. (a) Oxidized polyethylene is the basic resin produced by the mild air oxida- [57 FR 12711, Apr. 13, 1992] tion of polyethylene. The polyethylene used in the oxidation process conforms § 172.275 Synthetic paraffin and suc- to the density, maximum n-hexane ex- cinic derivatives. tractable fraction, and maximum xy- Synthetic paraffin and succinic de- lene soluble fraction specifications pre- rivatives identified in this section may scribed in item 2.3 of the table in be safely used as a component of food, § 177.1520(c) of this chapter. The subject to the following restrictions: oxidized polyethylene has a minimum (a) The additive is prepared with 50 number average molecular weight of percent Fischer-Tropsch process syn- 1,200, as determined by high tempera- thetic paraffin, meeting the definition ture vapor pressure osmometry; con- and specifications of § 172.615, and 50 tains a maximum of 5 percent by percent of such synthetic paraffin to weight of total oxygen; and has an acid which is bonded succinic anhydride and value of 9 to 19. succinic acid derivatives of isopropyl (b) The additive is used or intended alcohol, polyethylene glycol, and poly- for use as a protective coating or com- propylene glycol. It consists of a mix- ponent of protective coatings for fresh ture of the Fischer-Tropsch process avocados, bananas, beets, coconuts, paraffin (alkane), alkyl succinic anhy- eggplant, garlic, grapefruit, lemons, dride, alkyl succinic anhydride iso- limes, mango, muskmelons, onions, or- propyl half ester, dialkyl succinic an- anges, papaya, peas (in pods), pine- hydride polyethylene glycol half ester,

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and dialkyl succinic anhydride poly- Subpart D—Special Dietary and propylene glycol half ester, where the Nutritional Additives alkane (alkyl) has a chain length of 30– 70 carbon atoms and the polyethylene § 172.310 Aluminum nicotinate. and polypropylene glycols have molec- Aluminum nicotinate may be safely ular weights of 600 and 260, respec- used as a source of niacin in foods for tively. special dietary use. A statement of the (b) The additive meets the following concentration of the additive, ex- specifications: Molecular weight, 880– pressed as niacin, shall appear on the ° ° 930; melting point, 215 –217 F; acid label of the food additive container or number, 43–47; and saponification num- on that of any intermediate premix ber, 75–78. prepared therefrom. (c) It is used or intended for use as a protective coating or component of § 172.315 Nicotinamide-ascorbic acid protective coatings for fresh grape- complex. fruit, lemons, limes, muskmelons, or- Nicotinamide-ascorbic acid complex anges, sweetpotatoes, and tangerines. may be safely used in accordance with (d) It is used in an amount not to ex- the following prescribed conditions: ceed that required to produce the in- (a) The additive is the product of the tended effect. controlled reaction between ascorbic acid and nicotinamide, melting in the § 172.280 Terpene resin. range 141 °C to 145 °C. The food additive terpene resin may (b) It is used as a source of ascorbic be safely used in accordance with the acid and nicotinamide in multivitamin following prescribed conditions: preparations. (a) The food additive is the beta- pinene polymer obtained by polym- § 172.320 Amino acids. erizing terpene hydrocarbons derived The food additive amino acids may from wood. It has a softening point of be safely used as nutrients added to 112 °C–118 °C, as determined by ASTM foods in accordance with the following method E28–67 (Reapproved 1982), conditions: ‘‘Standard Test Method for Softening (a) The food additive consists of one Point By Ring-and-Ball Apparatus,’’ or more of the following individual which is incorporated by reference. amino acids in the free, hydrated, or Copies may be obtained from the Amer- anhydrous form, or as the hydro- ican Society for Testing Materials, 100 chloride, sodium, or potassium salts: Barr Harbor Dr., West Conshohocken, (1) L-Alanine Philadelphia, PA 19428-2959, or may be (2) L-Arginine examined at the National Archives and (3) L-Asparagine Records Administration (NARA). For (4) L-Aspartic acid information on the availability of this (5) L-Cysteine material at NARA, call 202–741–6030, or (6) L-Cystine go to: http://www.archives.gov/ (7) L-Glutamic acid federallregister/ (8) L-Glutamine codeloflfederallregulations/ (9) Aminoacetic acid (glycine) ibrllocations.html. (10) L-Histidine (b) It is used or intended for use as (11) L-Isoleucine follows: (12) L-Leucine (13) L-Lysine (1) As a moisture barrier on soft gela- (14) DL-Methionine (not for infant tin capsules in an amount not to ex- foods) ceed 0.07 percent of the weight of the (15) L-Methionine capsule. (16) L-Phenylalanine (2) As a moisture barrier on powders (17) L-Proline of ascorbic acid or its salts in an (18) L-Serine amount not to exceed 7 percent of the (19) L-Threonine weight of the powder. (20) L-Tryptophan [42 FR 14491, Mar. 15, 1977, as amended at 49 (21) L-Tyrosine FR 10104, Mar. 19, 1984] (22) L-Valine

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(b) The food additive meets the fol- method specified in paragraph (d) of lowing specifications: this section. (1) As found in Food Chemicals (3) Each amino acid (or combination Codex: of the minimum number necessary to (i) L-Alanine, pages 28 and 29. achieve a statistically significant in- (ii) L-Arginine, pages 69 and 70. crease) added results in a statistically (iii) L-Arginine Monohydrochloride, significant increase in the PER as de- pages 70 and 71. termined by the method described in (iv) L-Cysteine Monohydrochloride, paragraph (d) of this section. The min- pages 269 and 270. imum amount of the amino acid(s) to (v) L-Cystine, pages 270 and 271. achieve the desired effect must be used (vi) Aminoacetic acid (glycine), pages and the increase in PER over the pri- 457 and 458. marily intact naturally occurring protein in the food must be substantiated (vii) L-Leucine, pages 577 and 578. as a statistically significant difference (viii) DL-Methionine, pages 641 and 642. with at least a probability (P) value of (ix) L-Methionine, pages 642 and 643. less than 0.05. (x) L-Tryptophan, pages 1060 and 1061. (4) The amount of the additive added (xi) L-Phenylalanine, pages 794 and 795. for nutritive purposes plus the amount (xii) L-Proline, pages 864 and 865. naturally present in free and combined (xiii) L-Serine, pages 915 and 916. (as protein) form does not exceed the (xiv) L-Threonine, pages 1031 and 1032. following levels of amino acids ex- (xv) L-Glutamic Acid Hydrochloride, pressed as percent by weight of the page 440. total protein of the finished food: (xvi) L-Isoleucine, pages 544 and 545. Percent by (xvii) L-Lysine Monohydrochloride, weight of total pages 598 and 599. protein (expressed as free (xviii) Monopotassium L-glutamate, amino acid) pages 697 and 698. (xix) L-Tyrosine, page 1061. L-Alanine ...... 6.1 L-Arginine ...... 6.6 (xx) L-Valine, pages 1072. L-Aspartic acid (including L-asparagine) ...... 7.0 (2) As found in ‘‘Specifications and L-Cystine (including L-cysteine) ...... 2.3 Criteria for Biochemical Compounds,’’ L-Glutamic acid (including L-glutamine) ...... 12.4 Aminoacetic acid (glycine) ...... 3.5 NAS/NRC Publication, for the fol- L-Histidine ...... 2.4 lowing: L-Isoleucine ...... 6.6 (i) L-Asparagine L-Leucine ...... 8.8 L-Lysine ...... 6.4 (ii) L-Aspartic acid L- and DL-Methionine ...... 3.1 (iii) L-Glutamine L-Phenylalanine ...... 5.8 L-Proline ...... 4.2 (iv) L-Histidine L-Serine ...... 8.4 (c) The additive(s) is used or intended L-Threonine ...... 5.0 for use to significantly improve the bi- L-Tryptophan ...... 1.6 L-Tyrosine ...... 4.3 ological quality of the total protein in L-Valine ...... 7.4 a food containing naturally occurring primarily intact protein that is consid- (d) Compliance with the limitations ered a significant dietary protein concerning PER under paragraph (c) of source, provided that: this section shall be determined by the (1) A reasonable daily adult intake of method described in sections 43.212– the finished food furnishes at least 6.5 43.216, ‘‘Official Methods of Analysis of grams of naturally occurring primarily the Association of Official Analytical intact protein (based upon 10 percent of Chemists.’’ Each manufacturer or per- the daily allowance for the ‘‘reference’’ son employing the additive(s) under adult male recommended by the Na- the provisions of this section shall tional Academy of Sciences in ‘‘Rec- keep and maintain throughout the pe- ommended Dietary Allowances,’’ NAS riod of his use of the additive(s) and for Publication No. 1694. a minimum of 3 years thereafter, (2) The additive(s) results in a pro- records of the tests required by this tein efficiency ratio (PER) of protein paragraph and other records required in the finished ready-to-eat food equiv- to assure effectiveness and compliance alent to casein as determined by the with this regulation and shall make

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such records available upon request at of Official Analytical Chemists,’’ 13th all reasonable hours by any officer or Ed. (1980). employee of the Food and Drug Admin- (ii) [Reserved] istration, or any other officer or em- (2) National Academy of Sciences, ployee acting on behalf of the Sec- available from the FDA Main Library, retary of Health and Human Services 10903 New Hampshire Ave., Silver and shall permit such officer or em- Spring, MD 20993: ployee to conduct such inventories of (i) ‘‘Recommended Dietary Allow- raw and finished materials on hand as ances,’’ NAS Publication No. 1694, 7th he deems necessary and otherwise to Ed. (1968). check the correctness of such records. (ii) ‘‘Specifications and Criteria for (e) To assure safe use of the additive, Biochemical Compounds,’’ NAS/NRC the label and labeling of the additive Publication, 3rd Ed. (1972). and any premix thereof shall bear, in (3) United States Pharmacopeial Con- addition to the other information re- vention, 12601 Twinbrook Pkwy., Rock- quired by the Act, the following: ville, MD 20852 (Internet address http:// (1) The name of the amino acid(s) www.usp.org): contained therein including the spe- (i) Food Chemicals Codex, 7th ed. cific optical and chemical form. (2010), pages 28, 29, 69, 70, 71, 269, 270, (2) The amounts of each amino acid 271, 440, 457, 458, 544, 545, 577, 578, 598, contained in any mixture. 599, 641, 642, 643, 697, 698, 794, 795, 864, (3) Adequate directions for use to 865, 915, 916, 1031, 1032, 1060, 1061, and provide a finished food meeting the 1072. limitations prescribed by paragraph (c) (ii) [Reserved] of this section. [78 FR 71461, Nov. 29, 2013] (f) The food additive amino acids added as nutrients to special dietary § 172.325 Bakers yeast protein. foods that are intended for use solely under medical supervision to meet nu- Bakers yeast protein may be safely tritional requirements in specific med- used in food in accordance with the fol- ical conditions and comply with the re- lowing conditions: quirements of part 105 of this chapter (a) Bakers yeast protein is the insol- are exempt from the limitations in uble proteinaceous material remaining paragraphs (c) and (d) of this section after the mechanical rupture of yeast and may be used in such foods at levels cells of Saccharomyces cerevisiae and re- not to exceed good manufacturing moval of whole cell walls by cen- practices. trifugation and separation of soluble (g) The standards required in this cellular materials. section are incorporated by reference (b) The additive meets the following into this section with the approval of specifications on a dry weight basis: the Director of the Federal Register (1) Zinc salts less than 500 parts per under 5 U.S.C. 552(a) and 1 CFR part 51. million (ppm) as zinc. Copies may be examined at the Food (2) Nucleic acid less than 2 percent. and Drug Administration’s Main Li- (3) Less than 0.3 ppm arsenic, 0.1 ppm brary, 10903 New Hampshire Ave., Bldg. cadmium, 0.4 ppm lead, 0.05 ppm mer- 2, Third Floor, Silver Spring, MD 20993, cury, and 0.3 ppm selenium. 301–796–2039, or at the National Ar- (c) The viable microbial content of chives and Records Administration the finished ingredient is: (NARA). For information on the avail- (1) Less than 10,000 organisms/gram ability of this material at NARA, call by aerobic plate count. 202–741–6030 or go to: http:// (2) Less than 10 yeasts and molds/ www.archives.gov/federal-register/cfr/ibr- gram. locations.html. (3) Negative for Salmonella, E. coli, (1) AOAC INTERNATIONAL, 481 coagulase positive Staphylococci, Clos- North Frederick Ave., suite 500, Gai- tridium perfringens, Clostridium botu- thersburg, MD 20877: linum, or any other recognized micro- (i) Sections 43.212–43.216, ‘‘Official bial pathogen or any harmful microbial Methods of Analysis of the Association toxin.

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(d) The ingredient is used in food as cordance with recognized good manu- a nutrient supplement as defined in facturing practice for fish to be used as § 170.3(o)(20) of this chapter. human food. (4) The additive shall be prepared by § 172.330 Calcium pantothenate, cal- extraction with hexane and food-grade cium chloride double salt. ethanol to remove fat and moisture. The food additive calcium chloride Solvent residues shall be reduced by double salt of calcium pantothenate drying. may be safely used in foods for special (b) The food additive meets the fol- dietary uses in accordance with good lowing specifications: (Where methods manufacturing practice and under the of determination are specified, they are following prescribed conditions: Association of Official Analytical (a) The food additive is of the d (dex- Chemists Methods, 13th ed., 1980, which trorotatory) or the dl (racemic) form. are incorporated by reference). 1 (b) To assure safe use of the additive, (1) Protein content, as N × 6.25, shall the label and labeling of the food addi- not be less than 90 percent by weight of tive container, or that of any inter- the final product, as determined by the mediate premixes prepared therefrom, method described in section 2.057, Im- shall bear, in addition to the other in- proved Kjeldahl Method for Nitrate- formation required by the Act, the fol- Free Samples (20)—Official Final Ac- lowing: tion. (1) The name of the additive ‘‘cal- (2) Moisture content shall not be cium chloride double salt of d-calcium more than 10 percent by weight of the pantothenate’’ or ‘‘calcium chloride final product, as determined by the double salt of dl-calcium panto- method described in section 24.003, Air thenate’’, whichever is appropriate. Drying (1)—Official First Action. (2) A statement of the appropriate (3) Fat content shall not be more concentration of the additive, ex- than 0.5 percent by weight of the final pressed as pantothenic acid. product, as determined by the method described in section 24.005, Crude Fat § 172.335 D-Pantothenamide. or Ether Extract—Official Final Ac- The food additive D-pantothenamide tion. as a source of pantothenic acid activ- (4) Solvent residues in the final prod- ity, may be safely used in foods for spe- uct shall not be more than 5 parts per cial dietary use in an amount not in million of hexane and 3.5 percent eth- excess of that reasonably required to anol by weight. produce its intended effect. [46 FR 38072, July 24, 1981, as amended at 47 FR 53344, Nov. 26, 1982; 54 FR 24897, June 12, § 172.340 Fish protein isolate. 1989] (a) The food additive fish protein iso- § 172.345 Folic acid (folacin). late may be safely used as a food supplement in accordance with the fol- Folic acid (CAS Reg. No. 59–30–3), lowing prescribed conditions: also known as folacin or folate, may be (1) The additive shall consist prin- safely used in food as a nutrient in ac- cipally of dried fish protein prepared cordance with the following prescribed from the edible portions of fish after conditions: removal of the heads, fins, tails, bones, (a) Folic acid is the chemical N-[4- scales, viscera, and intestinal contents. [[(2-amino-1,4-dihydro-4-oxo-6-pteri- (2) The additive shall be derived only dinyl)methyl]amino]benzoyl]-L-glu- from species of bony fish that are gen- tamic acid. erally recognized by qualified sci- entists as safe for human consumption 1 Copies are available from: AOAC INTER- and that can be processed as prescribed NATIONAL, 481 North Frederick Ave., suite to meet the required specifications. 500, Gaithersburg, MD 20877, or examined at (3) Only wholesome fresh fish other- the National Archives and Records Adminis- tration (NARA). For information on the wise suitable for human consumption availability of this material at NARA, call may be used. The fish shall be handled 202–741–6030, or go to: http://www.archives.gov/ expeditiously under sanitary condi- federallregister/codeloflfederallregulations/ tions. These conditions shall be in ac- ibrllocations.html.

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(b) Folic acid meets the specifica- (h) Folic acid may be added to foods tions of the Food Chemicals Codex, 9th represented as meal-replacement prod- ed., updated through Third Supple- ucts, in amounts not to exceed: ment, effective December 1, 2015, pp. (1) Four hundred μg per serving if the 495–496, which is incorporated by ref- food is a meal-replacement that is rep- erence. The Director of the Office of resented for use once per day; or the Federal Register approves this in- (2) Two hundred μg per serving if the corporation by reference in accordance food is a meal-replacement that is rep- with 5 U.S.C. 552(a) and 1 CFR part 51. resented for use more than once per You may obtain copies from the United day. States Pharmacopeial Convention, (i) Folic acid may be added to corn 12601 Twinbrook Pkwy., Rockville, MD masa flour at a level not to exceed 0.7 milligrams of folic acid per pound of 20852 (Internet address http:// corn masa flour. www.usp.org). Copies may be examined at the Food and Drug Administration’s [61 FR 8807, Mar. 5, 1996, as amended at 61 FR Main Library, 10903 New Hampshire 27779, June 3, 1996; 64 FR 1758, Jan. 12, 1999; 78 Ave., Bldg. 2, Third Floor, Silver FR 71463, Nov. 29, 2013; 81 FR 22183, Apr. 15, 2016] Spring, MD 20993, 301–796–2039, or at the National Archives and Records Admin- § 172.350 Fumaric acid and salts of fu- istration (NARA). For information on maric acid. the availability of this material at Fumaric acid and its calcium, fer- NARA, call 202–741–6030 or go to: http:// rous, magnesium, potassium, and so- www.archives.gov/federal-register/cfr/ibr- dium salts may be safely used in food locations.html. in accordance with the following pre- (c) Folic acid may be added to foods scribed conditions: subject to a standard of identity estab- (a) The additives meet the following lished under section 401 of the Federal specifications: Food, Drug, and Cosmetic Act (the act) (1) Fumaric acid contains a minimum when the standard of identity specifi- of 99.5 percent by weight of fumaric cally provides for the addition of folic acid, calculated on the anhydrous acid. basis. (d) Folic acid may be added, at levels (2) The calcium, magnesium, potas- not to exceed 400 micrograms (μg) per sium, and sodium salts contain a min- serving, to breakfast cereals, as defined imum of 99 percent by weight of the re- under § 170.3(n)(4) of this chapter, and spective salt, calculated on the anhy- to corn grits at a level such that each drous basis. Ferrous fumarate contains pound of corn grits contains not more a minimum of 31.3 percent total iron than 1.0 milligram of folic acid. and not more than 2 percent ferric iron. (e) Folic acid may be added to infant (b) With the exception of ferrous fu- formula in accordance with section marate, fumaric acid and the named 412(i)(1) of the act or with regulations salts are used singly or in combination issued under section 412(i)(2) of the act in food at a level not in excess of the which are codified in § 107.100 of this amount reasonably required to accom- chapter. plish the intended effect. (f) Folic acid may be added to a med- (c) Ferrous fumarate is used as a ical food, as defined in section 5(b)(3) of source of iron in foods for special die- the Orphan Drug Act (21 U.S.C. tary use, when the use is consistent 360ee(b)(3)), at levels not to exceed the with good nutrition practice. amount necessary to meet the distinc- tive nutritional requirements of the § 172.365 Kelp. disease or condition for which the food Kelp may be safely added to a food as is formulated. a source of the essential mineral io- (g) Folic acid may be added to food dine, provided the maximum intake of for special dietary use at levels not to the food as may be consumed during a exceed the amount necessary to meet period of one day, or as directed for use the special dietary needs for which the in the case of a dietary supplement, food is formulated. will not result in daily ingestion of the

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additive so as to provide a total marily intact vegetable protein that is amount of iodine in excess of 225 considered a significant dietary protein micrograms for foods labeled without source, provided that: reference to age or physiological state; (1) A reasonable daily adult intake of and when age or the conditions of preg- the finished food furnishes at least 6.5 nancy or lactation are specified, in ex- grams of naturally occurring primarily cess of 45 micrograms for infants, 105 intact vegetable protein. micrograms for children under 4 years (2) The additive results in a protein of age, 225 micrograms for adults and efficiency ratio (PER) of protein in the children 4 or more years of age, and 300 finished ready-to-eat food equivalent micrograms for pregnant or lactating to casein as determined by the method women. The food additive kelp is the specified in paragraph (d) of this sec- dehydrated, ground product prepared tion. from Macrocystis pyrifera, Laminaria (3) The use of the additive results in digitata, Laminaria saccharina, and Lam- a statistically significant increase in inaria cloustoni. the PER as determined by the method described in paragraph (d) of this sec- § 172.370 Iron-choline citrate complex. tion. The minimum amount of the ad- Iron-choline citrate complex made by ditive to achieve the desired effect reacting approximately equimolecular must be used, and the increase in PER quantities of ferric hydroxide, choline, over the primarily intact naturally oc- and citric acid may be safely used as a curring vegetable protein in the food source of iron in foods for special die- must be substantiated as a statis- tary use. tically significant difference with at least a probability (P) value of less § 172.372 N-Acetyl-L-methionine. than 0.05. The food additive N-acetyl-L-methio- (4) The amount of the additive added nine may be safely added to food (ex- for nutritive purpose shall not exceed cept infant foods and foods containing the level that will provide a total of 3.1 added nitrites/nitrates) as a source of percent L- and DL-methionine (ex- L-methionine for use as a nutrient in pressed as the free amino acid) by accordance with the following condi- weight of the total protein of the fin- tions: ished food, including the amount natu- (a) N-Acetyl-L-methionine (Chemical rally present in free and combined (as Abstracts Service Registry No. 65–82–7) protein) form. is the derivative of the amino acid me- (5) The additive shall not be added to thionine formed by addition of an ace- infant foods or to foods containing tyl group to the alpha-amino group of added nitrites/nitrates. methionine. It may be in the free, hy- (d) Compliance with the limitations drated or anhydrous form, or as the so- concerning PER under paragraph (c) of dium or potassium salts. the section shall be determined by the (b) The additive meets the following method described in sections 43.212– specifications: 43.216, ‘‘Official Methods of Analysis of (1) Purity assay, on a dry basis: Min- the Association of Official Analytical imum 99 percent. Chemists,’’ 13th Ed. (1980), which is in- (2) Residue on ignition: Maximum 0.1 corporated by reference. Copies may be percent. obtained from the AOAC INTER- (3) Specific optical rotation NATIONAL, 481 North Frederick Ave., 20 [alpha] D: Between ¥19° and ¥23°. suite 500, Gaithersburg, MD 20877, or (4) The additive may contain residues may be examined at the National Ar- of not more than 500 ppm ethyl ace- chives and Records Administration tate; 50 ppm ethyl alcohol; 10 ppm (NARA). For information on the avail- methyl alcohol; and 10 ppm acetone, ability of this material at NARA, call when used as processing solvents. 202–741–6030, or go to: http:// (c) The additive is used or intended www.archives.gov/federallregister/ for use as a source of L-methionine to codeloflfederallregulations/ improve significantly the biological ibrllocations.html. Each manufacturer quality of the total protein in a food or person employing the additive under containing naturally occurring pri- the provisions of this section shall

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keep and maintain throughout the pe- provide a total amount of iodine in ex- riod of use of the additive and for a cess of 225 micrograms for foods labeled minimum of 3 years thereafter, records without reference to age or physio- of the tests required by this paragraph logical state; and when age or the con- and other records required to assure ef- ditions of pregnancy or lactation are fectiveness and compliance with this specified, in excess of 45 micrograms regulation. Those records shall be for infants, 105 micrograms for children made available upon request at all rea- under 4 years of age, 225 micrograms sonable hours by any officer or em- for adults and children 4 or more years ployee acting on behalf of the Sec- of age, and 300 micrograms for preg- retary of Health and Human Services. nant or lactating women. Those officers or employees shall be (b) To assure safe use of the additive, permitted to conduct inventories of in addition to the other information re- raw and finished materials on hand as quired by the Act, the label of the addi- are deemed necessary to verify the tive shall bear: records. (1) The name of the additive. (e) To assure safe use of the additive, (2) A statement of the concentration the label and labeling of the additive of the additive in any mixture. and any premix thereof shall bear, in addition to the other information re- § 172.379 Vitamin D 2. quired by the Act, the following: Vitamin D2 may be used safely in (1) The name of the additive con- foods as a nutrient supplement defined tained therein. under § 170.3(o)(20) of this chapter in ac- (2) The amounts of additive and each cordance with the following prescribed amino acid contained in any mixture. conditions: (3) Adequate directions for use to (a) Vitamin D2, also known as provide a finished food meeting the ergocalciferol, is the chemical 9,10- limitations prescribed by paragraph (c) seco(5Z,7E,22E)-5,7,10(19),22- of this section. ergostatetraen-3-ol. Vitamin D2 is pro- (f) When the food additive is added as duced by ultraviolet irradiation of er- a nutrient to special dietary foods that gosterol isolated from yeast and is pu- are intended for use solely under med- rified by crystallization. ical supervision to meet nutritional re- (b) Vitamin D2 meets the specifica- quirements in specific medical conditions of the 2015 Food Chemical Codex, tions and these foods comply with the 9th edition (through Third Supple- requirements of part 105 of this chap- ment), effective December 1, 2015, pp. ter, the food additive is exempt from 1260–1261, which is incorporated by ref- the limitations in paragraphs (c)(1) erence. The Director of the Office of through (4) and (d) of this section and the Federal Register approves this in- may be used in those foods at levels corporation by reference in accordance not to exceed good manufacturing with 5 U.S.C. 552(a) and 1 CFR part 51. practices. You may obtain copies from the United [43 FR 27784, June 27, 1978, as amended at 46 States Pharmacopeial Convention, FR 59968, Dec. 8, 1981; 49 FR 10104, Mar. 19, 12601 Twinbrook Pkwy., Rockville, MD 1984; 54 FR 24897, June 12, 1989] 20852 (Internet address http:// www.usp.org). Copies may be examined § 172.375 Potassium iodide. at the Food and Drug Administration’s The food additive potassium iodide Main Library, 10903 New Hampshire may be safely used in accordance with Ave., Bldg. 2, Third Floor, Silver the following prescribed conditions: Spring, MD 20993, 301–796–2039, or at the (a) Potassium iodide may be safely National Archives and Records Admin- added to a food as a source of the es- istration (NARA). For information on sential mineral iodine, provided the the availability of this material at maximum intake of the food as may be NARA, call 202–741–6030 or go to: http:// consumed during a period of one day, www.archives.gov/federal-register/cfr/ibr- or as directed for use in the case of a locations.html. dietary supplement, will not result in (c) The additive may be used as fol- daily ingestion of the additive so as to lows:

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Category of Food Maximum Levels in Food (as Served)

Edible plant-based beverages intended as milk alternatives 84 IU/100 g.

Edible plant-based yogurt alternatives 89 IU/100 g.

Soy beverage products 89 IU/100 g

Soy-based butter substitute spreads 330 IU/100 g

Soy-based cheese substitutes and soy-based cheese substitute 270 IU/100 g products

[74 FR 11022, Mar. 16, 2009, as amended at 78 equal to 330 milligrams (mg) of calcium FR 71463, Nov. 29, 2013; 81 FR 46581, July 18, per 240 mL, excluding fruit juices that 2016] are specially formulated or processed for infants. § 172.380 Vitamin D . 3 (2) At levels not to exceed 100 IU per Vitamin D3 may be used safely in 240 mL in fruit juice drinks (as defined foods as a nutrient supplement defined under § 170.3(n)(35) of this chapter) that under § 170.3(o)(20) of this chapter in ac- are fortified with greater than or equal cordance with the following prescribed to 100 mg of calcium per 240 mL, ex- conditions: cluding fruit juice drinks that are spe- (a) Vitamin D3, also known as chole- cially formulated or processed for in- calciferol, is the chemical 9,10- fants. seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. (3) At levels not to exceed 140 IU per Vitamin D occurs in and is isolated 3 240 mL (prepared beverage) in soy-pro- from fish liver oils. It also is manufac- tein based meal replacement beverages tured by ultraviolet irradiation of 7-de- (powder or liquid) that are represented hydrocholesterol produced from choles- for special dietary use in reducing or terol and is purified by crystallization. (b) Vitamin D meets the specifica- maintaining body weight in accordance 3 with § 105.66 of this chapter. tions of ‘‘Vitamin D3,’’, Food Chemi- cals Codex, 11th ed., copyright 2018, pp. (4) At levels not to exceed 100 IU per 1243–1244, which is incorporated by ref- 40 grams in meal replacement bars or erence. The Director of the Office of other-type bars that are represented the Federal Register approves this infor special dietary use in reducing or corporation by reference in accordance maintaining body weight in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. with § 105.66 of this chapter. You may obtain copies from the United (5) At levels not to exceed 81 IU per 30 States Pharmacopeial Convention, grams in cheese and cheese products as 12601 Twinbrook Pkwy., Rockville, MD defined under § 170.3(n)(5) of this chap- 20852 (internet address http:// ter, excluding cottage cheese, ricotta www.usp.org). Copies may be examined cheese, and hard grating cheeses such at the Food and Drug Administration’s as Parmesan and Romano as defined in Main Library, 10903 New Hampshire §§ 133.165 and 133.183 of this chapter, and Ave., Bldg. 2, Third Floor, Silver those defined by standard of identity in Spring, MD 20993, 301–796–2039, or at the § 133.148 of this chapter. National Archives and Records Admin- (6) At levels not to exceed 500 IU per istration (NARA). For information on 240 mL (prepared beverage) in meal re- the availability of this material at placement beverages that are not in- NARA, call 202–741–6030, or go to: http:// tended for special dietary use in reduc- www.archives.gov/federal-register/cfr/ibr- ing or maintaining body weight and locations.html. that are represented for use such that (c) The additive may be used as fol- the total amount of Vitamin D3 pro- lows: vided by the product does not exceed (1) At levels not to exceed 100 Inter- 1,000 IU per day. national Units (IU) per 240 milliliters (7) At levels not to exceed 1.0 IU per (mL) in 100 percent fruit juices (as de- kilocalorie in foods represented for use fined under § 170.3(n)(35) of this chapter) as a sole source of nutrition for enteral that are fortified with greater than or feeding.

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(8) At levels not to exceed 84 IU per § 172.385 Whole fish protein con- 100 g (800 IU/quart) in milk that concentrate. tains more than 42 IU vitamin D per 100 The food additive whole fish protein g (400 IU/quart) and that meets the re- concentrate may be safely used as a quirements for foods named by use of a food supplement in accordance with nutrient content claim and a standard- the following prescribed conditions: ized term in accordance with § 130.10 of (a) The additive is derived from this chapter. whole, wholesome hake and hakelike [68 FR 9003, Feb. 27, 2003, as amended at 70 fish, herring of the genera Clupea, men- FR 36025, June 22, 2005; 70 FR 37257, June 29, haden, and anchovy of the species En- 2005; 70 FR 69438, Nov. 16, 2005; 78 FR 71463, graulis mordax, handled expeditiously Nov. 29, 2013; 79 FR 46996, Aug. 12, 2014; 81 FR and under sanitary conditions in ac- 46582, July 18, 2016; 83 FR 47559, Sept. 20, 2018] cordance with good manufacturing practices recognized as proper for fish § 172.381 Vitamin D bakers yeast. 2 that are used in other forms for human Vitamin D2 bakers yeast may be used food. safely in foods as a source of vitamin (b) The additive consists essentially D2 and as a leavening agent in accord- of a dried fish protein processed from ance with the following prescribed con- the whole fish without removal of ditions: heads, fins, tails, viscera, or intestinal (a) Vitamin D2 bakers yeast is the contents. It is prepared by solvent ex- substance produced by exposing bakers traction of fat and moisture with iso- yeast (Saccharomyces cerevisiae) to ul- propyl alcohol or with ethylene dichlo- traviolet light, resulting in the photo- ride followed by isopropyl alcohol, ex- chemical conversion of endogenous er- cept that the additive derived from gosterol in bakers yeast to vitamin D2 herring, menhaden and anchovy is pre- (also known as ergocalciferol or (9,10- pared by solvent extraction with iso- seco(5Z,7E,22E)-5,7,10(19),22- propyl alcohol alone. Solvent residues ergostatetraen-3-ol)). are reduced by conventional heat dry- (b) Vitamin D2 bakers yeast may be ing and/or microwave radiation and used alone as an active dry yeast con- there is a partial removal of bone. centrate or in combination with con- (c) The food additive meets the fol- ventional bakers yeast. lowing specifications: (c) The additive may be used in (1) Protein content (N × 6.25) shall yeast-leavened baked goods and baking not be less than 75 percent by weight of mixes and yeast-leavened baked snack the final product, as determined by the foods at levels not to exceed 400 Inter- method described in section 2.057 in national Units of vitamin D2 per 100 ‘‘Official Methods of Analysis of the grams in the finished food. Association of Official Analytical (d) To assure safe use of the additive, Chemists’’ (AOAC), 13th Ed. (1980). Pro- the label or labeling of the food addi- tein quality shall not be less than 100, tive container shall bear, in addition to as determined by the method described the other information required by the in sections 43.212–43.216 of the AOAC. Federal Food, Drug, and Cosmetic Act, The 13th Ed. is incorporated by ref- adequate directions for use to provide a erence, and copies may be obtained final product that complies with the from the AOAC INTERNATIONAL, 481 limitations prescribed in paragraph (c) North Frederick Ave., suite 500, Gai- of this section. thersburg, MD 20877, or may be exam- (e) Labels of manufactured food prod- ined at the National Archives and ucts containing the additive shall bear, Records Administration (NARA). For in the ingredient statement, the name information on the availability of this of the additive, ‘‘vitamin D2 bakers material at NARA, call 202–741–6030, or yeast,’’ in the proper order of decreas- go to: http://www.archives.gov/ ing predominance in the finished food. federallregister/ [77 FR 52231, Aug. 29, 2012] codeloflfederallregulations/ ibrllocations.html.

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(2) Moisture content shall not exceed limitations prescribed by paragraphs 10 percent by weight of the final prod- (d) and (e) of this section. uct, as determined by the method de- (3) Labels of manufactured foods con- scribed in section 24.003 of the AOAC. taining the additive shall bear, in the See paragraph (c)(1) of this section for ingredient statement, the name of the availability of the material incor- additive, ‘‘whole fish protein con- porated by reference. centrate’’ in the proper order of de- (3) Fat content shall not exceed 0.5 creasing predominance in the finished percent by weight of the final product, food. as determined by the method described in section 24.005 of the AOAC. See para- [42 FR 14491, Mar. 15, 1977, as amended at 49 graph (c)(1) of the this section for FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, availability of the material incor- 1989] porated by reference. (4) The additive may contain residues § 172.395 Xylitol. of isopropyl alcohol and ethylene di- Xylitol may be safely used in foods chloride not in excess of 250 parts per for special dietary uses, provided the million and 5 parts per million, respec- amount used is not greater than that tively, when used as solvents in the ex- required to produce its intended effect. traction process. (5) Microwave radiation meeting the § 172.399 Zinc methionine sulfate. requirements of § 179.30 of this chapter Zinc methionine sulfate, CAS Reg. may be used to reduce residues of the No. 56329–42–1, may be safely used in solvents used in the extraction process. (6) The additive shall contain not in accordance with the following pre- excess of 100 parts per million fluorides scribed conditions: (expressed as F). (a) The additive is the product of the (7) The additive shall be free of Esch- reaction between equimolar amounts of erichia coli and pathogenic organisms, zinc sulfate and DL-methionine in puri- including Salmonella, and shall have a fied water. total bacterial plate count of not more (b) The additive meets the following than 10,000 per gram. specifications: (8) The additive shall have no more than a faint characteristic fish odor Zinc content—19 to 22 percent. C H NO S ‘‘DL-methionine’’—46 to 50 per- and taste. 5 11 2 cent. (d) When the additive is used or in- Cadmium—not more than 0.05 part per mil- tended for use in the household as a lion. protein supplement in food for regular consumption by children up to 8 years (c) The additive is used in tablet form of age, the amount of the additive from as a source of dietary zinc. this source shall not exceed 20 grams [46 FR 58297, Dec. 1, 1981] per day (about one heaping table- spoon). (e) When the additive is used as a Subpart E—Anticaking Agents protein supplement in manufactured food, the total fluoride content (ex- § 172.410 Calcium silicate. pressed as F) of the finished food shall Calcium silicate, including synthetic not exceed 8 ppm based on the dry calcium silicate, may be safely used in weight of the food product. food in accordance with the following (f) To assure safe use of the additive, prescribed conditions: in addition to the other information re- (a) It is used as an anticaking agent quired by the Act: in food in an amount not in excess of (1) The label of consumer-sized or that reasonably required to produce its bulk containers of the additive shall intended effect. bear the name ‘‘whole fish protein con- (b) It will not exceed 2 percent by centrate’’. weight of the food, except that it may (2) The label or labeling of containers of the additive shall bear adequate di- be present up to 5 percent by weight of rections for use to comply with the baking powder.

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§ 172.430 Iron ammonium citrate. foods for special dietary use, in an amount not greater than that required Iron ammonium citrate may be safe- to accomplish the intended physical or ly used in food in accordance with the technical effect. following prescribed conditions: (a) The additive is the chemical § 172.490 Yellow prussiate of soda. green ferric ammonium citrate. (b) The additive is used, or intended (a) The food additive yellow prussiate for use as an anticaking agent in salt of soda (sodium ferrocyanide decahy- for human consumption so that the drate; Na4Fe(CN)6·10H2O contains a level of iron ammonium citrate does minimum of 99 percent by weight of so- not exceed 25 parts per million (0.0025 dium ferrocyanide decahydrate. percent) in the finished salt. (b) The additive is used or intended (c) To assure safe use of the additive for use as an anticaking agent in salt the label or labeling of the additive and as an adjuvant in the production of shall bear, in addition to the other in- dendritic crystals of salt in an amount formation required by the Act: needed to produce its intended effect (1) The name of the additive. but not in excess of 13 parts per million (2) Adequate directions to provide a calculated as anhydrous sodium ferro- final product that complies with the cyanide. limitations prescribed in paragraph (b) [42 FR 14491, Mar. 15, 1977, as amended at 58 of this section. FR 17098, Apr. 1, 1993]

§ 172.480 Silicon dioxide. Subpart F—Flavoring Agents and The food additive silicon dioxide may Related Substances be safely used in food in accordance with the following conditions: § 172.510 Natural flavoring substances (a) The food additive is manufactured and natural substances used in con- by vapor phase hydrolysis or by other junction with flavors. means whereby the particle size is such Natural flavoring substances and as to accomplish the intended effect. natural adjuvants may be safely used (b) It is used as an anticaking agent, in food in accordance with the fol- subject to the following conditions: lowing conditions. (1) It is used in only those foods in (a) They are used in the minimum which the additive has been dem- quantity required to produce their in- onstrated to have an anticaking effect. tended physical or technical effect and (2) It is used in an amount not in ex- in accordance with all the principles of cess of that reasonably required to good manufacturing practice. produce its intended effect. (b) In the appropriate forms (plant (3) [Reserved] parts, fluid and solid extracts, con- (4) It is used in an amount not to ex- centrates, absolutes, oils, gums, bal- ceed 2 percent by weight of the food. sams, resins, oleoresins, waxes, and dis- (c) It is used or intended for use as a tillates) they consist of one or more of stabilizer in the production of beer, and the following, used alone or in com- is removed from the beer by filtration bination with flavoring substances and prior to final processing. adjuvants generally recognized as safe (d) It is used or intended for use as an in food, previously sanctioned for such adsorbent for dl-a-tocopheryl acetate use, or regulated in any section of this and pantothenyl alcohol in tableted part.

Common name Scientific name Limitations

Aloe ...... Aloe perryi Baker, A. barbadensis Mill., A. ferox Mill., and hybrids of this sp. with A. africana Mill. and A. spicata Baker. Althea root and flowers ...... Althea officinalis L. Amyris (West Indian sandalwood) ...... Amyris balsamifera L. Angola weed ...... Roccella fuciformis Ach ...... In alcoholic beverages only Arnica flowers ...... Arnica montana L., A. fulgens Pursh, A. sororia Do. Greene, or A. cordifolia Hooker.

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Common name Scientific name Limitations

Artemisia (wormwood) ...... Artemisia spp ...... Finished food thujone free 1 Artichoke leaves ...... Cynara scolymus L ...... In alcoholic beverages only Benzoin resin ...... Styrax benzoin Dryander, S. paralleloneurus Per- kins, S. tonkinensis (Pierre) Craib ex Hartwich, or other spp. of the Section Anthostyrax of the genus Styrax. Blackberry bark ...... Rubus, Section Eubatus. Boldus (boldo) leaves ...... Peumus boldus Mol ...... Do. Boronia flowers ...... Boronia megastigma Nees. Bryonia root ...... Bryonia alba L., or B. diocia Jacq ...... Do. Buchu leaves ...... Barosma betulina Bartl. et Wendl., B. crenulata (L.) Hook. or B. serratifolia Willd. Buckbean leaves ...... Menyanthes trifoliata L ...... Do. Cajeput ...... Melaleuca leucadendron L. and other Melaleuca spp. Calumba root ...... Jateorhiza palmata (Lam.) Miers ...... Do. Camphor tree ...... Cinnamomum camphora (L.) Nees et Eberm ...... Safrole free Cascara sagrada ...... Rhamnus purshiana DC. Cassie flowers ...... Acacia farnesiana (L.) Willd. Castor oil ...... Ricinus communis L. Catechu, black ...... Acacia catechu Willd. Cedar, white (aborvitae), leaves and twigs ... Thuja occidentalis L ...... Finished food thujone free 1 Centuary ...... Centaurium umbellatum Gilib ...... In alcoholic beverages only Cherry pits ...... Prunus avium L. or P. cerasus L ...... Not to exceed 25 p.p.m. prussic acid Cherry-laurel leaves ...... Prunus laurocerasus L ...... Do. Chestnut leaves ...... Castanea dentata (Marsh.) Borkh. Chirata ...... Swertia chirata Buch.-Ham ...... In alcoholic beverages only Cinchona, red, bark ...... Cinchona succirubra Pav. or its hybrids ...... In beverages only; not more than 83 p.p.m. total cinchona alkaloids in finished beverage Cinchona, yellow, bark ...... Cinchona ledgeriana Moens, C. calisaya Wedd., or Do. hybrids of these with other spp. of Cinchona.. Copaiba ...... South American spp. of Copaifera L. Cork, oak ...... Quercus suber L., or Q. occidentalis F. Gay ...... In alcoholic beverages only Costmary ...... Chrysanthemum balsamita L ...... Do. Costus root ...... Saussurea lappa Clarke. Cubeb ...... Piper cubeba L. f. Currant, black, buds and leaves ...... Ribes nigrum L. Damiana leaves ...... Turnera diffusa Willd. Davana ...... Artemisia pallens Wall. Dill, Indian ...... Anethum sowa Roxb. (Peucedanum graveolens Benth et Hook., Anethum graveolens L.). Dittany (fraxinella) roots ...... Dictamnus albus L ...... Do. Dittany of Crete ...... Origanum dictamnus L. Dragon’s blood (dracorubin) ...... Daemonorops spp. Elder tree leaves ...... Sambucus nigra L ...... In alcoholic beverages only; not to exceed 25 p.p.m. prussic acid in the flavor Elecampane rhizome and roots ...... Inula helenium L ...... In alcoholic beverages only Elemi ...... Canarium commune L. or C. luzonicum Miq. Erigeron ...... Erigeron canadensis L. Eucalyptus globulus leaves ...... Eucalyptus globulus Labill. Fir (‘‘pine’’) needles and twigs ...... Abies sibirica Ledeb., A. alba Mill., A. sachalinesis Masters or A. mayriana Miyabe et Kudo. Fir, balsam, needles and twigs ...... Abies balsamea (L.) Mill. Galanga, greater ...... Alpinia galanga Willd ...... Do. Galbanum ...... Ferula galbaniflua Boiss. et Buhse and other Ferula spp. Gambir (catechu, pale) ...... Uncaria gambir Roxb. Genet flowers ...... Spartium junceum L. Gentian rhizome and roots ...... Gentiana lutea L. Gentian, stemless ...... Gentiana acaulis L ...... Do. Germander, chamaedrys ...... Teucrium chamaedrys L ...... Do. Germander, golden ...... Teucrium polium L ...... Do. Guaiac ...... Guaiacum officinale L., G. santum L., Bulnesia sarmienti Lor.

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Common name Scientific name Limitations

Guarana ...... Paullinia cupana HBK. Haw, black, bark ...... Viburnum prunifolium L. Hemlock needles and twigs ...... Tsuga canadensis (L.) Carr. or T. heterophylla (Raf.) Sarg. Hyacinth flowers ...... Hyacinthus orientalis L. Iceland moss ...... Cetraria islandica Ach ...... Do. Imperatoria ...... Peucedanum ostruthium (L.). Koch (Imperatoria ostruthium L.). Iva ...... Achillea moschata Jacq ...... Do. Labdanum ...... Cistus spp. Lemon-verbena ...... Lippia citriodora HBK ...... Do. Linaloe wood ...... Bursera delpechiana Poiss. and other Bursera spp. Linden leaves ...... Tillia spp ...... Do. Lovage ...... Levisticum officinale Koch. Lungmoss (lungwort) ...... Sticta pulmonacea Ach. Maidenhair fern ...... Adiantum capillus-veneris L ...... Do. Maple, mountain ...... Acer spicatum Lam. Mimosa (black wattle) flowers ...... Acacia decurrens Willd. var. dealbata. Mullein flowers ...... Verbascum phlomoides L. or V. thapsiforme Schrad Do. Myrrh ...... Commiphora molmol Engl., C. abyssinica (Berg) Engl., or other Commiphora spp. Myrtle leaves ...... Myrtus communis L ...... Do. Oak, English, wood ...... Quercus robur L ...... Do. Oak, white, chips ...... Quercus alba L. Oak moss ...... Evernia prunastri (L.) Ach., E. furfuracea (L.) Mann, Finished food thujone and other lichens. free 1 Olibanum ...... Boswellia carteri Birdw. and other Boswellia spp. Opopanax (bisabolmyrrh) ...... Opopanax chironium Koch (true opopanax) of Commiphora erythraea Engl. var. Llabrescens. Orris root ...... Iris germanica L. (including its variety florentina Dykes) and I. pallida Lam. Pansy ...... Viola tricolor L ...... In alcoholic beverages only Passion flower ...... Passiflora incarnata L. Patchouly ...... Pogostemon cablin Benth. and P. heyneanus Benth. Peach leaves ...... Prunus persica (L.) Batsch ...... In alcoholic beverages only; not to exceed 25 p.p.m. prussic acid in the flavor Pennyroyal, American ...... Hedeoma pulegioides (L.) Pers. Pennyroyal, European ...... Mentha pulegium L. Pine, dwarf, needles and twigs ...... Pinus mugo Turra var. pumilio (Haenke) Zenari. Pine, Scotch, needles and twigs ...... Pinus sylvestris L. Pine, white, bark ...... Pinus strobus L ...... In alcoholic beverages only Pine, white oil ...... Pinus palustris Mill., and other Pinus spp. Poplar buds ...... Populus balsamifera L. (P. tacamahacca Mill.), P. Do. candicans Ait., or P. nigra L. Quassia ...... Picrasma excelsa (Sw.) Planch, or Quassia amara L. Quebracho bark ...... Aspidosperma quebracho-blanco Schlecht, or Schinopsis lorentzii (Quebrachia lorentzii (Griseb)). (Griseb.) Engl. Quillaia (soapbark) ...... Quillaja saponaria Mol. Red saunders (red sandalwood) ...... Pterocarpus san alinus L ...... In alcoholic beverages only Rhatany root ...... Krameria triandra Ruiz et Pav. or K. argentea Mart. Rhubarb, garden root ...... Rheum rhaponticum L ...... Do. Rhubarb root ...... Rheum officinale Baill., R. palmatum L., or other spp. (excepting R. rhaponticum L.) or hybrids of Rheum grown in China. Roselle ...... Hibiscus sabdariffa L ...... Do. Rosin (colophony) ...... Pinus palustris Mill., and other Pinus spp ...... Do. St. Johnswort leaves, flowers, and caulis ...... Hypericum perforatum L ...... Hypericin-free alcohol distillate form only; in alcoholic beverages only Sandalwood, white (yellow, or East Indian) ... Santalum album L. Sandarac ...... Tetraclinis articulata (Vahl.), Mast ...... In alcoholic beverages only Sarsaparilla ...... Smilax aristolochiaefolia Mill., (Mexican sarsaparilla), S. regelii Killip et Morton (Honduras sarsaparilla), S. febrifuga Kunth (Ecuadorean sarsaparilla), or undetermined Smilax spp. (Ecuadorean or Central American sarsaparilla). Sassafras leaves ...... Sassafras albidum (Nutt.) Nees ...... Safrole free Senna, Alexandria ...... Cassia acutifolia Delile.

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Common name Scientific name Limitations

Serpentaria (Virginia snakeroot) ...... Aristolochia serpentaria L ...... In alcoholic beverages only Simaruba bark ...... Simaruba amara Aubl ...... Do. Snakeroot, Canadian (wild ginger) ...... Asarum canadense L. Spruce needles and twigs ...... Picea glauca (Moench) Voss or P. mariana (Mill.) BSP. Storax (styrax) ...... Liquidambar orientalis Mill. or L. styraciflua L. Tagetes (marigold) ...... Tagetes patula L., T. erecta L., or T. minuta L. (T. As oil only glandulifera Schrank). Tansy ...... Tanacetum vulgare L ...... In alcoholic beverages only; finished alcoholic beverage thujone free 1 Thistle, blessed (holy thistle) ...... Onicus benedictus L ...... In alcoholic beverages only Thymus capitatus (Spanish ‘‘origanum’’) ...... Thymus capitatus Hoffmg. et Link. Tolu ...... Myroxylon balsamum (L.) Harms. Turpentine ...... Pinus palustris Mill. and other Pinus spp. which yield terpene oils exclusively. Valerian rhizome and roots ...... Valeriana officinalis L. Veronica ...... Veronica officinalis L ...... Do. Vervain, European ...... Verbena officinalis L ...... Do. Vetiver ...... Vetiveria zizanioides Stapf ...... Do. Violet, Swiss ...... Viola calcarata L. Walnut husks (hulls), leaves, and green nuts Juglans nigra L. or J. regia L. Woodruff, sweet ...... Asperula odorata L ...... In alcoholic beverages only Yarrow ...... Achillea millefolium L ...... In beverages only; finished beverage thujone free 1 Yerba santa ...... Eriodictyon californicum (Hook, et Arn.) Torr. Yucca, Joshua-tree ...... Yucca brevifolia Engelm. Yucca, Mohave ...... Yucca schidigera Roezl ex Ortgies (Y. mohavensis Sarg.). 1 As determined by using the method (or, in other than alcoholic beverages, a suitable adaptation thereof) in section 9.129 of the ‘‘Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/codeloflfederallregulations/ ibrllocations.html.

[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 14644, Apr. 7, 1978; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 69 FR 24511, May 4, 2004; 72 FR 10357, Mar. 8, 2007]

§ 172.515 Synthetic flavoring sub- Allyl anthranilate. stances and adjuvants. Allyl butyrate. Allyl cinnamate. Synthetic flavoring substances and Allyl cyclohexaneacetate. adjuvants may be safely used in food in Allyl cyclohexanebutyrate. accordance with the following condi- Allyl cyclohexanehexanoate. tions. Allyl cyclohexaneproprionate. (a) They are used in the minimum Allyl cyclohexanevalerate. quantity required to produce their in- Allyl disulfide. tended effect, and otherwise in accord- Allyl 2-ethylbutyrate. ance with all the principles of good Allyl hexanoate; allyl caproate. Allyl a-ionone; 1-(2,6,6-trimethyl-2-cyclo-hex- manufacturing practice. ene-1-yl)-1,6-heptadiene-3-one. (b) They consist of one or more of the Allyl isothiocyanate; mustard oil. following, used alone or in combination Allyl isovalerate. with flavoring substances and adju- Allyl mercaptan; 2-propene-1-thiol. vants generally recognized as safe in Allyl nonanoate. food, prior-sanctioned for such use, or Allyl octanoate. regulated by an appropriate section in Allyl phenoxyacetate. this part. Allyl phenylacetate. Allyl propionate. Acetal; acetaldehyde diethyl acetal. Allyl sorbate; allyl 2,4-hexadienoate. Acetaldehyde phenethyl propyl acetal. Allyl sulfide. Acetanisole; 4′-methoxyacetophenone. Allyl tiglate; allyl trans-2-methyl-2- Acetophenone; methyl phenyl ketone. butenoate.

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Allyl 10-undecenoate. Butyl alcohol; 1-butanol. Ammonium isovalerate. Butyl anthranilate. Ammonium sulfide. Butyl butyrate. Amyl alcohol; pentyl alcohol. Butyl butyryllactate; lactic acid, butyl Amyl butyrate. ester, butyrate. a-Amylcinnamaldehyde. a-Butylcinnamaldehyde. a-Amylcinnamaldehyde dimethyl acetal. Butyl cinnamate. a-Amylcinnamyl acetate. Butyl 2-decenoate. a-Amylcinnamyl alcohol. Butyl ethyl malonate. a-Amylcinnamyl formate. Butyl formate. a-Amylcinnamyl isovalerate. Butyl heptanoate. Amyl formate. Butyl hexanoate. Amyl heptanoate. Butyl p-hydroxybenzoate. Amyl hexanoate. Butyl isobutyrate. Amyl octanoate. Butyl isovalerate. Anisole; methoxybenzene. Butyl lactate. Anisyl acetate. Butyl laurate. Anisyl alcohol; p-methoxybenzyl alcohol. Butyl levulinate. Anisyl butyrate Butyl phenylacetate. Anisyl formate. Butyl propionate. Anisyl phenylacetate. Butyl stearate. Anisyl propionate. Butyl sulfide. Beechwood creosote. Butyl 10-undecenoate. Benzaldehyde dimethyl acetal. Butyl valerate. Benzaldehyde glyceryl acetal; 2-phenyl-m-di- Butyraldehyde. oxan-5-ol. Cadinene. Benzaldehyde propylene glycol acetal; 4- Camphene; 2,2-dimethyl-3-methylene- methyl-2-phenyl-m-dioxolane. norbornane. Benzenethiol; thiophenol. d-Camphor. Benzoin; 2-hydroxy-2-phenylacetophenone. Carvacrol; 2-p-cymenol. Benzyl acetate. Carvacryl ethyl ether; 2-ethoxy-p-cymene. Benzyl acetoacetate. Carveol; p-mentha-6,8-dien-2-ol. Benzyl alcohol. 4-Carvomenthenol; 1-p-menthen-4-ol; 4- Benzyl benzoate. terpinenol. Benzyl butyl ether. cis Carvone oxide; 1,6-epoxy-p-menth-8-en-2- Benzyl butyrate. one. Benzyl cinnamate. Carvyl acetate. Benzyl 2,3–dimethylcrotonate; benzyl methyl Carvyl propionate. tiglate. b-Caryophyllene. Benzyl disulfide; dibenzyl disulfide. Caryophyllene alcohol. Benzyl ethyl ether. Caryophyllene alcohol acetate. Benzyl formate. b-Caryophyllene oxide; 4-12,12-trimethyl-9- 3-Benzyl-4-heptanone; benzyl dipropyl ke- methylene-5-oxatricylo [8.2.0.0 46] dode- tone. cane. Benzyl isobutyrate. Cedarwood oil alcohols. Benzyl isovalerate. Cedarwood oil terpenes. Benzyl mercaptan; a-toluenethiol. 1,4-Cineole. Benzyl methoxyethyl acetal; acetaldehyde Cinnamaldehyde ethylene glycol acetal. benzyl b-methoxyethyl acetal. Cinnamic acid. Benzyl phenylacetate. Cinnamyl acetate. Benzyl propionate. Cinnamyl alcohol; 3-phenyl-2-propen-1-ol. Benzyl salicylate. Cinnamyl benzoate. Birch tar oil. Cinnamyl butyrate. Borneol; d-camphanol. Cinnamyl cinnamate. Bornyl acetate. Cinnamyl formate. Bornyl formate. Cinnamyl isobutyrate. Bornyl isovalerate. Cinnamyl isovalerate. Bornyl valerate. Cinnamyl phenylacetate. b-Bourbonene; 1,2,3,3a,3bb,4,5,6,6ab,6ba-deca- Cinnamyl propionate. hydro-la-isopropyl-3aa-methyl-6-meth- Citral diethyl acetal; 3,7-dimethyl-2,6-octa- ylene-cyclobuta [1,2:3,4] dicyclopentene. dienal diethyl acetal. 2-Butanol. Citral dimethyl acetal; 3,7-dimethyl-2,6-octa- 2-Butanone; methyl ethyl ketone. dienal dimethyl acetal. Butter acids. Citral propylene glycol acetal. Butter esters. Citronellal; 3,7-dimethyl-6-octenal; rhodinal. Butyl acetate. Citronellol; 3,7-dimethyl-6-octen-1-ol; d-cit- Butyl acetoacetate. ronellol.

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Citronelloxyacetaldehyde. delta-Dodecalactone; 5-hydroxydodecanoic Citronellyl acetate. acid, deltalactone. Citronellyl butyrate. g-Dodecalactone; 4-hydroxydodecanoic acid g- Citronellyl formate. lactone. Citronellyl isobutyrate. 2-Dodecenal. Citronellyl phenylacetate. Estragole. Citronellyl propionate. r-Ethoxybenzaldehyde. Citronellyl valerate. Ethyl acetoacetate. p-Cresol. Ethyl 2-acetyl-3-phenylpropionate; ethyl- Cuminaldehyde; cuminal; p-isopropyl benz- benzyl acetoacetate. aldehyde. Ethyl aconitate, mixed esters. Cyclohexaneacetic acid. Ethyl r-anisate. Cyclohexaneethyl acetate. Ethyl anthranilate. Cyclohexyl acetate. Ethyl benzoate. Cyclohexyl anthranilate. Ethyl benzoylacetate. Cyclohexyl butyrate. a-Ethylbenzyl butyrate; a-phenylpropyl bu- Cyclohexyl cinnamate. tyrate. Cyclohexyl formate. Ethyl brassylate; tridecanedioic acid cyclic Cyclohexyl isovalerate. ethylene glycol diester; cyclo 1,13-ethyl- Cyclohexyl propionate. enedioxytridecan-1,13-dione. p-Cymene. 2-Ethylbutyl acetate. g-Decalactone; 4-hydroxy-decanoic acid, g- 2-Ethylbutyraldehyde. lactone. 2-Ethylbutyric acid. g-Decalactone; 5-hydroxy-decanoic acid, d- Ethyl cinnamate. lactone. Ethyl crotonate; trans-2-butenoic acid ethyl- Decanal dimethyl acetal. ester. 1-Decanol; decylic alcohol. Ethyl cyclohexanepropionate. 2-Decenal. Ethyl decanoate. 3-Decen-2-one; heptylidene acetone. 2-Ethylfuran. Decyl actate. Ethyl 2-furanpropionate. Decyl butyrate. 4-Ethylguaiacol; 4-ethyl-2-methoxyphenol. Decyl propionate. Ethyl heptanoate. Dibenzyl ether. 2-Ethyl-2-heptenal; 2-ethyl-3-butylacrolein. 4,4-Dibutyl-g-butyrolactone; 4,4-dibutyl-4-hy- Ethyl hexanoate. droxy-butyric acid, g-lactone. Ethyl isobutyrate. Dibutyl sebacate. Ethyl isovalerate. Diethyl malate. Ethyl lactate. Diethyl malonate; ethyl malonate. Ethyl laurate. Diethyl sebacate. Ethyl levulinate. Diethyl succinate. Ethyl maltol; 2-ethyl-3-hydroxy-4H-pyran-4- Diethyl tartrate. one. 2,5-Diethyltetrahydrofuran. Ethyl 2-methylbutyrate. Dihydrocarveol; 8-p-menthen-2-ol; 6-methyl- Ethyl myristate. 3-isopropenylcyclohexanol. Ethyl nitrite. Dihydrocarvone. Ethyl nonanoate. Dihydrocarvyl acetate. Ethyl 2-nonynoate; ethyl octyne carbonate. m-Dimethoxybenzene. Ethyl octanoate. p-Dimethoxybenzene; dimethyl hydro- Ethyl oleate. quinone. Ethyl phenylacetate. 2,4-Dimethylacetophenone. Ethyl 4-phenylbutyrate. a,a-Dimethylbenzyl isobutyrate; phenyldi- Ethyl 3-phenylglycidate. methylcarbinyl isobutyrate. Ethyl 3-phenylpropionate; ethyl hydro- 2,6-Dimethyl-5-heptenal. cinnamate. 2,6-Dimethyl octanal; isodecylaldehyde. Ethyl propionate. 3,7-Dimethyl-1-octanol; tetrahydrogeraniol. Ethyl pyruvate. a,a-Dimethylphenethyl acetate; benzyl- Ethyl salicylate. propyl acetate; benzyldimethylcarbinyl ac- Ethyl sorbate; ethyl 2,4-hexadienoate. etate. Ethyl tiglate; ethyl trans-2-methyl-2- a,a-Dimethylphenethyl alcohol; dimethyl- butenoate. benzyl carbinol. Ethyl undecanoate. a,a-Dimethylphenethyl butyrate; benzyl- Ethyl 10-undecenoate. dimethylcarbinyl butyrate. Ethyl valerate. a,a-Dimethylphenethyl formate; benzyldi- Eucalyptol; 1,8-epoxy-p-menthane; cineole. methylcarbinyl formate. Eugenyl acetate. Dimethyl succinate. Eugenyl benzoate. 1,3-Diphenyl-2-propanone; dibenzyl ketone. Eugenyl formate.

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Farnesol; 3,7,11-trimethyl-2,6,10-dodecatrien- Hexyl alcohol. 1-ol. Hexyl butyrate. d-Fenchone; d-1,3,3-trimethyl-2-nor- a-Hexylcinnamaldehyde. bornanone. Hexyl formate. Fenchyl alcohol; 1,3,3-trimethyl-2-nor- Hexyl hexanoate. bornanol. 2-Hexylidene cyclopentanone. Formic acid Hexyl isovalerate. (2-Furyl)-2-propanone; furyl acetone. Hexyl 2-methylbutyrate. 1-Furyl-2-propanone; furyl acetone. Hexyl octanoate. Fusel oil, refined (mixed amyl alcohols). Hexyl phenylacetate; n-hexyl phenylacetate. Geranyl acetoacetate; trans-3,7-dimethyl-2, 6- Hexyl propionate. octadien-1-yl acetoacetate. Hydroxycitronellal; 3,7-dimethyl-7-hydroxy- Geranyl acetone; 6,10-dimethyl-5,9- octanal. undecadien-2-one. Hydroxycitronellal diethyl acetal. Geranyl benzoate. Hydroxycitronellal dimethyl acetal. Geranyl butyrate. Hydroxycitronellol; 3,7-dimethyl-1,7- Geranyl formate. octanediol. Geranyl hexanoate N-(4-Hydroxy-3-methoxybenzyl)-nonanamide; Geranyl isobutyrate. pelargonyl vanillylamide. Geranyl isovalerate. 5-Hydroxy-4-octanone; butyroin. Geranyl phenylacetate. 4-(p-Hydroxyphenyl)-2-butanone; p-hydroxy- Geranyl propionate. benzyl acetone. Glucose pentaacetate. Indole. Guaiacol; μ-methoxyphenol. a-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1- Guaiacyl acetate; μ-methoxyphenyl acetate. yl)-3-buten-2-one. Guaiacyl phenylacetate. b-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1- Guaiene; 1,4-dimethyl-7-isopropenyl-D9,10- yl)-3-buten-2-one. octahydroazulene. a-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene- Guaiol acetate; 1,4-dimethyl-7-(a-hydroxy- 1-yl)-3-buten-2-one; 6-methylionone. isopropyl)-d9,10-octahydroazulene acetate. Isoamyl acetate. g-Heptalactone; 4-hydroxyheptanoic acid, g- Isoamyl acetoacetate. lactone. Isoamyl alcohol; isopentyl alcohol; 3-methyl- Heptanal; enanthaldehyde. 1-butanol. Heptanal dimethyl acetal. Isoamyl benzoate. Heptanal 1,2-glyceryl acetal. Isoamyl butyrate. 2,3-Heptanedione; acetyl valeryl. Isoamyl cinnamate. 3-Heptanol. Isoamyl formate. 2-Heptanone; methyl amyl ketone. Isoamyl 2-furanbutyrate; a-isoamyl furfuryl- 3-Heptanone; ethyl butyl ketone. propionate. 4-Heptanone; dipropyl ketone. Isoamyl 2-furanpropionate; a-isoamyl fur- cis-4-Heptenal; cis-4-hepten-1-al. furylacetate. Heptyl acetate. Isoamyl hexanoate. Heptyl alcohol; enanthic alcohol. Isoamyl isobutyrate. Heptyl butyrate. Isoamyl isovalerate. Heptyl cinnamate. Isoamyl laurate. Heptyl formate. Isoamyl-2-methylbutyrate; isopentyl-2- Heptyl isobutyrate. methylbutyrate. Heptyl octanoate. Isoamyl nonanoate. 1-Hexadecanol; cetyl alcohol. Isoamyl octanoate. w-6-Hexadecenlactone; 16-hydroxy-6- Isoamyl phenylacetate. hexadecenoic acid, w-lactone; Isoamyl propionate. ambrettolide. Isoamyl pyruvate. g-Hexalactone; 4-hydroxyhexanoic acid, g-lac- Isoamyl salicylate. tone; tonkalide. Isoborneol. Hexanal; caproic aldehyde. Isobornyl acetate. 2,3-Hexanedione; acetyl butyryl. Isobornyl formate. Hexanoic acid; caproic acid. Isobornyl isovalerate. 2-Hexenal. Isobornyl propionate. 2-Hexen-1-ol. Isobutyl acetate. 3-Hexen-1-ol; leaf alcohol. Isobutyl acetoacetate. 2-Hexen-1-yl acetate. Isobutyl alcohol. 3-Hexenyl isovalerate. Isobutyl angelate; isobutyl cis-2-methyl-2- 3-Hexenyl 2-methylbutyrate. butenoate. 3-Hexenyl phenylacetate; cis-3-hexenyl phen- Isobutyl anthranilate. ylacetate. Isobutyl benzoate. Hexyl acetate. Isobutyl butyrate. 2-Hexyl-4-acetoxytetrahydrofuran. Isobutyl cinnamate.

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Isobutyl formate. Linalyl hexanoate. Isobutyl 2-furanpropionate. Linalyl isobutyrate. Isobutyl heptanoate. Linalyl isovalerate. Isobutyl hexanoate. Linalyl octanoate. Isobutyl isobutyrate. Linalyl propionate. a-Isobutylphenethyl alcohol; isobutyl benzyl Maltol; 3-hydroxy-2-methyl-4H-pyran-4-one. carbinol; 4-methyl-1-phenyl-2-pentanol. Menthadienol; p-mentha-1,8(10)-dien-9-ol. Isobutyl phenylacetate. p-Mentha-1,8-dien-7-ol; perillyl alcohol. Isobutyl propionate. Menthadienyl acetate; p-mentha-1,8(10)-dien- Isobutyl salicylate. 9-yl acetate. 2-Isobutylthiazole. p-Menth-3-en-1-ol. Isobutyraldehyde. 1-p-Menthen-–9-yl acetate; p-menth-1-en-9-yl Isobutyric acid. acetate. Isoeugenol; 2-methoxy-4-propenylphenol. Menthol; 2-isopropyl-5-methylcyclohexanol. Isoeugenyl acetate. Menthone; p-menthan-3-one. Isoeugenyl benzyl ether; benzyl isoeugenol. Menthyl acetate; p-menth-3-yl acetate. Isoeugenyl ethyl ether; 2-ethoxy-5-propenyl- Menthyl isovalerate; p-menth-3-yl iso- anisole; ethyl isoeugenol. valerate. Isoeugenyl formate. o-Methoxybenzaldehyde. Isoeugenyl methyl ether; 4-propenyl- p-Methoxybenzaldehyde; p-anisaldehyde. veratrole; methyl isoeugenol. o-Methoxycinnamaldehyde. Isoeugenyl phenylacetate. 2-Methoxy-4-methylphenol; 4-methyl- Isojasmone; mixture of 2-hexylidenecyclo- guaiacol; 2-methoxy-p-cresol. pentanone and 2-hexyl-2-cyclopenten-1-one. 4-(p-Methoxyphenyl)-2-butanone; anisyl ace- -Isomethylionone; 4-(2,6,6-trimethyl-2- a tone. cyclohexen-1-yl)-3-methyl-3-buten-2-one; 1-(4-Methoxyphenyl)-4-methyl-1-penten-3- methyl -ionone. g one; methoxystyryl isopropyl ketone. Isopropyl acetate. 1-(p-Methoxyphenyl)-1-penten-3-one; a- r-Isopropylacetophenone. methylanisylidene acetone; ethone. Isopropyl alcohol; isopropanol. Isopropyl benzoate. 1-(p-Methoxyphenyl)-2-propanone; anisylmethyl ketone; anisic ketone. r-Isopropylbenzyl alcohol; cuminic alcohol; 2-Methoxy-4-vinylphenol; p-vinylguaiacol. r-cymen-7-ol. Isopropyl butyrate. Methyl acetate. ′ Isopropyl cinnamate. 4 -Methylacetophenone; p-methylaceto- Isopropyl formate. phenone; methyl p-tolyl ketone. Isopropyl hexanoate. 2-Methylallyl butyrate; 2-methyl-2-propenl- Isopropyl isobutyrate. yl butyrate. Isopropyl isovalerate. Methyl anisate. r-Isopropylphenylacetaldehyde; r-cymen-7- o-Methylanisole; o-cresyl methyl ether. carboxaldehyde. p-Methylanisole; p-cresyl methyl ether; p- Isopropyl phenylacetate. methoxytoluene. 3-(r-Isopropylphenyl)-propionaldehyde; r-iso- Methyl benzoate. propylhydrocinnamaldehyde; cuminyl ac- Methylbenzyl acetate, mixed o-,m-,p-. etaldehyde. a-Methylbenzyl acetate; styralyl acetate. Isopropyl propionate. a-Methylbenzyl alcohol; styralyl alcohol. Isopulegol; p-menth-8-en-3-ol. a-Methylbenzyl butyrate; styralyl butyrate. Isopulegone; p-menth-8-en-3-one. a-Methylbenzyl isobutyrate; styralyl iso- Isopulegyl acetate. butyrate. Isoquinoline. a-Methylbenzyl formate; styralyl formate. Isovaleric acid. a-Methylbenzyl propionate; styralyl propio- cis-Jasmone; 3-methyl-2-(2-pentenyl)-2-cyclo- nate. penten-1-one. 2-Methyl-3-buten-2-ol. Lauric aldehyde; dodecanal. 2-Methylbutyl isovalerate. Lauryl acetate. Methyl p-tert-butylphenylacetate. Lauryl alcohol; 1-dodecanol. 2-Methylbutyraldehyde; methyl ethyl acetal- Lepidine; 4-methylquinoline. dehyde. Levulinic acid. 3-Methylbutyraldehyde; isovaleraldehyde. Linalool oxide; cis- and trans-2-vinyl-2-meth- Methyl butyrate. yl-5-(1′-hydroxy-1′-methylethyl) tetra- 2-Methylbutyric acid. hydrofuran. a-Methylcinnamaldehyde. Linalyl anthranilate; 3,7-dimethyl-1,6- p-Methylcinnamaldehyde. octadien-3-yl anthranilate. Methyl cinnamate. Linalyl benzoate. 2-Methyl-1,3-cyclohexadiene. Linalyl butyrate. Methylcyclopentenolone; 3-methylcyclopen- Linalyl cinnamate. tane-1,2-dione. Linalyl formate. Methyl disulfide; dimethyl disulfide.

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Methyl ester of rosin, partially hydrogenated 2-Methylundecanal; methyl nonyl acetal- (as defined in § 172.615); methyl dehyde. dihydroabietate. Methyl 9-undecenoate. Methyl heptanoate. Methyl 2-undecynoate; methyl decyne car- 2-Methylheptanoic acid. bonate. 6-Methyl-3,5-heptadien-2-one. Methyl valerate. Methyl-5-hepten-2-ol. 2-Methylvaleric acid. 6-Methyl-5-hepten-2-one. Myristaldehyde; tetradecanal. Methyl hexanoate. d-Neomenthol; 2-isopropyl-5-methylcyclo- Methyl 2-hexanoate. hexanol. Methyl p-hydroxybenzoate; methylparaben. Nerol; cis-3,7-dimethyl-2,6-octadien-1-ol. Methyl a-ionone; 5-(2,6,6-trimethyl-2-cyclo- Nerolidol; 3,7,11-trimethyl-1,6,10-dodecatrien- hexen-1-yl)-4-penten-3-one. 3-ol. Methyl b-ionone; 5-(2,6,6-trimethyl-1-cyclo- Neryl acetate. hexen-1-yl)-4-penten-3-one. Neryl butyrate. Methyl D-ionone; 5-(2,6,6-trimethyl-3-cyclo- Neryl formate. hexen-1-yl-)-4-penten-3-one. Neryl isobutyrate. Methyl isobutyrate. Neryl isovalerate. 2-Methyl-3-(p-isopropylphenyl)-propionalde- Neryl propionate. hyde; a-methyl-p-isopropylhydro- 2,6-Nonadien-1-ol. cinnamaldehyde; cyclamen aldehyde. g-Nonalactone; 4-hydroxynonanoic acid, g- Methyl isovalerate. lactone; aldehyde C–18. Methyl laurate. Nonanal; pelargonic aldehyde. Methyl mercaptan; methanethiol. 1,3-Nonanediol acetate, mixed esters. Nonanoic acid; pelargonic acid. Methyl o-methoxybenzoate. 2-Nonanone; methylheptyl ketone. Methyl N-methylanthranilate; dimethyl an- 3-Nonanon-1-yl acetate; 1-hydroxy-3- thranilate. nonanone acetate. Methyl 2-methylbutyrate. Nonyl acetate. Methyl-3-methylthiopropionate. Nonyl alcohol; 1-nonanol. Methyl 4-methylvalerate. Nonyl octanoate. Methyl myristate. Nonyl isovalerate. ′ Methyl b-naphthyl ketone; 2 -acetonaph- Nootkatone; 5,6-dimethyl-8-isopropenyl- thone. bicyclo[4,4,0]-dec-1-en-3-one. Methyl nonanoate. Ocimene; trans-b-ocimene; 3,7-dimethyl-1,3,6- Methyl 2-nonenoate. octatriene. Methyl 2-nonynoate; methyloctyne car- g-Octalactone; 4-hydroxyoctanoic acid, g-lac- bonate. tone. 2-Methyloctanal; methyl hexyl acetaldehyde. Octanal; caprylaldehyde. Methyl octanoate. Octanal dimethyl acetal. Methyl 2-octynoate; methyl heptine car- 1-Octanol; octyl alcohol. bonate. 2-Octanol. 4-Methyl-2,3-pentanedione; acetyl iso- 3-Octanol. butyryl. 2-Octanone; methyl hexyl ketone. 4-Methyl-2-pentanone; methyl isobutyl ke- 3-Octanone; ethyl amyl ketone. tone. 3-Octanon-1-ol. b-Methylphenethyl alcohol; hydratropyl al- 1-Octen-3-ol; amyl vinyl carbinol. cohol. 1-Octen-3-yl acetate. Methyl phenylacetate. Octyl acetate. 3-Methyl-4-phenyl-3-butene-2-one. 3-Octyl acetate. 2-Methyl-4-phenyl-2-butyl acetate; dimethyl- Octyl butyrate. phenylethyl carbinyl acetate. Octyl formate. 2-Methyl-4-phenyl-2-butyl isobutyrate; Octyl heptanoate. dimethylphenyl ethylcarbinyl isobutyrate. Octyl isobutyrate. 3-Methyl-2-phenylbutyraldehyde; a-isopropyl Octyl isovalerate. phenylacetaldehyde. Octyl octanoate. Methyl 4-phenylbutyrate. Octyl phenylacetate. 4-Methyl-1-phenyl-2-pentanone; benzyl iso- Octyl propionate. butyl ketone. w-Pentadecalactone; 15-hydroxypentadeca- Methyl 3-phenylpropionate; methyl hydro- noic acid, w-lactone; pentadecanolide; an- cinnamate. gelica lactone. Methyl propionate. 2,3-Pentanedione; acetyl propionyl. 3-Methyl-5-propyl-2-cyclohexen-1-one. 2-Pentanone; methyl propyl ketone. Methyl sulfide. 4-Pentenoic acid. 3-Methylthiopropionaldehyde; methional. 1-Penten-3-ol. 2-Methyl-3-tolylpropionaldehyde, mixed o-, Perillaldehyde; 4-isopropenyl-1-cyclohexene- m-, p-. 1-carboxaldehyde;p-mentha-1,8-dien-7-al.

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Perillyl acetate; p-mentha-1,8-dien-7-yl ace- Polylimonene. tate. Polysorbate 20; polyoxyethylene (20) sorbitan a-Phellandrene; r-mentha-1,5-diene. monolaurate. Phenethyl acetate. Polysorbate 60; polyoxyethylene (20) sorbitan Phenethyl alcohol; b-phenylethyl alcohol. monostereate. Phenethyl anthranilate. Polysorbate 80; polyoxyethylene (20) sorbitan Phenethyl benzoate. monooleate. Phenethyl butyrate. Potassium acetate. Phenethyl cinnamate. Propenylguaethol; 6-ethoxy-m-anol. Phenethyl formate. Propionaldehyde. Phenethyl isobutyrate. Propyl acetate. Phenethyl isovalerate. Propyl alcohol; 1-propanol. Phenethyl 2-methylbutyrate. p-Propyl anisole; dihydroanethole. Phenethyl phenylacetate. Propyl benzoate. Phenethyl propionate. Propyl butyrate. Phenethyl salicylate. Propyl cinnamate. Phenethyl senecioate; phenethyl 3,3-di- Propyl disulfide. methylacrylate. Propyl formate. Phenethyl tiglate. Propyl 2-furanacrylate. Phenoxyacetic acid. Propyl heptanoate. 2-Phenoxyethyl isobutyrate. Propyl hexanoate. Phenylacetaldehyde; -toluic aldehyde. a Propyl p-hydroxybenzoate; propylparaben. Phenylacetaldehyde 2,3-butylene glycol ace- 3-Propylidenephthalide. tal. Propyl isobutyrate. Phenylacetaldehyde dimethyl acetal. Propyl isovalerate. Phenylacetaldehyde glyceryl acetal. Propyl mercaptan. Phenylacetic acid; a-toluic acid. 4-Phenyl-2-butanol; phenylethyl methyl car- a-Propylphenethyl alcohol. binol. Propyl phenylacetate. 4-Phenyl-3-buten-2-ol; methyl styryl car- Propyl propionate. binol. Pyroligneous acid extract. 4-Phenyl-3-buten-2-one. Pyruvaldehyde. 4-Phenyl-2-butyl acetate; phenylethyl meth- Pyruvic acid. yl carbinyl acetate. Rhodinol; 3,7-dimethyl-7-octen-1-ol; l- 1-Phenyl-3-methyl-3-pentanol; phenylethyl citronellol. methyl ethyl carbinol. Rhodinyl acetate. 1-Phenyl-1-propanol; phenylethyl carbinol. Rhodinyl butyrate. 3-Phenyl-1-propanol; hydrocinnamyl alcohol. Rhodinyl formate. 2-Phenylpropionaldehyde; hydratropalde- Rhodinyl isobutyrate. hyde. Rhodinyl isovalerate. 3-Phenylpropionaldehyde; hydrocinnamal- Rhodinyl phenylacetate. dehyde. Rhodinyl propionate. 2-Phenylpropionalde-hyde dimethyl acetal; Rum ether; ethyl oxyhydrate. hydratropic aldehyde dimethyl acetal. Salicylaldehyde. 3-Phenylpropionic acid; hydrocinnamic acid. Santalol, a and b. 3-Phenylpropyl acetate. Santalyl acetate. 2-Phenylpropyl butyrate. Santalyl phenylacetate. 3-Phenylpropyl cinnamate. Skatole. 3-Phenylpropyl formate. Sorbitan monostearate. 3-Phenylpropyl hexanoate. Sucrose octaacetate. 2-Phenylpropyl isobutyrate. a-Terpinene. 3-Phenylpropyl isobutyrate. g-Terpinene. 3-Phenylpropyl isovalerate. a-Terpineol; p-menth-1-en-8-ol. 3-Phenylpropyl propionate. b-Terpineol. 2-(3-Phenylpropyl)-tetrahydrofuran. Terpinolene; p-menth-1,4(8)-diene. a-Pinene; 2-pinene. Terpinyl acetate. b-Pinene; 2(10)-pinene. Terpinyl anthranilate. Pine tar oil. Terpinyl butyrate. Pinocarveol; 2(10)-pinen-3-ol. Terpinyl cinnamate. Piperidine. Terpinyl formate. Piperine. Terpinyl isobutyrate. d-Piperitone; p-menth-1-en-3-one. Terpinyl isovalerate. Piperitenone; p-mentha-1,4(8)-dien-3-one. Terpinyl propionate. Piperitenone oxide; 1,2-epoxy-p-menth-4-(8)- Tetrahydrofurfuryl acetate. en-3-one. Tetrahydrofurfuryl alcohol. Piperonyl acetate; heliotropyl acetate. Tetrahydrofurfuryl butyrate. Piperonyl isobutyrate. Tetrahydrofurfuryl propionate.

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Tetrahydro-pseudo-ionone; 6,10-dimethyl-9- § 172.520 Cocoa with dioctyl sodium undecen-2-one. sulfosuccinate for manufacturing. Tetrahydrolinalool; 3,7-dimethyloctan-3-ol. Tetramethyl ethylcyclohexenone; mixture of The food additive ‘‘cocoa with dioctyl 5-ethyl-2,3,4,5-tetramethyl-2-cyclohexen-1- sodium sulfosuccinate for manufac- one and 5-ethyl-3,4,5,6-tetramethyl-2-cyclo- turing,’’ conforming to § 163.117 of this hexen-1-one. chapter and § 172.810, is used or in- 2-Thienyl mercaptan; 2-thienylthiol. tended for use as a flavoring substance Thymol. in dry beverage mixes whereby the Tolualdehyde glyceryl acetal, mixed o, m, p. amount of dioctyl sodium sulfo- Tolualdehydes, mixed o, m, p. succinate does not exceed 75 parts per p-Tolylacetaldehyde. million of the finished beverage. The o-Tolyl acetate; o-cresyl acetate. labeling of the dry beverage mix shall p-Tolyl acetate; p-cresyl acetate. 4-(p-Tolyl)-2-butanone; p-methylbenzylace- bear adequate directions to assure use tone. in compliance with this section. p-Tolyl isobutyrate. p-Tolyl laurate. § 172.530 Disodium guanylate. p-Tolyl phenylacetate. Disodium guanylate may be safely 2-(p-Tolyl)-propionaldehyde; p-methylhydra- used as a flavor enhancer in foods, at a tropic aldehyde. level not in excess of that reasonably Tributyl acetylcitrate. required to produce the intended effect. 2-Tridecenal. 2,3-Undecadione; acetyl nonyryl. § 172.535 Disodium inosinate. g-Undecalactone; 4-hydroxyundecanoic acid g-lactone; peach aldehyde; aldehyde C–14. The food additive disodium inosinate Undecenal. may be safely used in food in accord- 2-Undecanone; methyl nonyl ketone. ance with the following prescribed con- 9-Undecenal; undecenoic aldehyde. ditions: 10-Undecenal. (a) The food additive is the disodium Undecen-1-ol; undecylenic alcohol. salt of inosinic acid, manufactured and 10-Undecen-1-yl acetate. purified so as to contain no more than Undecyl alcohol. 150 parts per million of soluble barium Valeraldehyde; pentanal. in the compound disodium inosinate Valeric acid; pentanoic acid. with seven and one-half molecules of Vanillin acetate; acetyl vanillin. water of crystallization. Veratraldehyde. Verbenol; 2-pinen-4-ol. (b) The food additive is used as a fla- Zingerone; 4-(4-hydroxy-3-methoxyphenyl)-2- voring adjuvant in food. butanone. § 172.540 DL-Alanine. (c) D-Decalactone and D- dodecalactone when used separately or DL-Alanine (a racemic mixture of D- in combination in oleomargarine are and L-alanine; CAS Reg. No. 302–72–7) used at levels not to exceed 10 parts per may be safely used as a flavor enhancer million and 20 parts per million, re- for sweeteners in pickling mixtures at spectively, in accordance with § 166.110 a level not to exceed 1 percent of the of this chapter. pickling spice that is added to the (d) BHA (butylated hydroxyanisole) pickling brine. may be used as an antioxidant in fla- [56 FR 6968, Feb. 21, 1991] voring substances whereby the additive does not exceed 0.5 percent of the es- § 172.560 Modified hop extract. sential (volatile) oil content of the fla- The food additive modified hop ex- voring substance. tract may be safely used in beer in ac- [42 FR 14491, Mar. 15, 1977, as amended at 42 cordance with the following prescribed FR 23148, May 6, 1977; 43 FR 19843, May 9, conditions: 1978; 45 FR 22915, Apr. 4, 1980; 47 FR 27810, (a) The food additive is used or in- June 25, 1982; 48 FR 10812, Mar. 15, 1983; 48 FR tended for use as a flavoring agent in 51907, Nov. 15, 1983; 49 FR 5747, Feb. 15, 1984; 50 FR 42932, Oct. 23, 1985; 54 FR 7402, Feb. 21, the brewing of beer. 1989; 61 FR 14245, Apr. 1, 1996; 69 FR 24511, (b) The food additive is manufactured May 4, 2004; 83 FR 50490, 50503, Oct. 9, 2018] by one of the following processes:

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(1) The additive is manufactured vents, followed by isomerization by po- from a hexane extract of hops by si- tassium carbonate treatment. Residues multaneous isomerization and selec- of solvents in the modified hop extract tive reduction in an alkaline aqueous shall not exceed 1.0 part per million of medium with sodium borohydride, benzene, 1.0 part per million of light whereby the additive meets the fol- petroleum spirits, 50 parts per million lowing specifications: of methyl alcohol, 50 parts per million (i) A solution of the food additive sol- of n-butyl alcohol, and 1 part per mil- ids is made up in approximately 0.012 n lion of ethyl acetate. The light petro- alkaline methyl alcohol (6 milliliters leum spirits and benzene solvents shall of 1 n sodium hydroxide diluted to 500 comply with the specifications in milliliters with methyl alcohol) to § 172.250 except that the boiling point show an absorbance at 253 millimicrons range for light petroleum spirits is 150 of 0.6 to 0.9 per centimeter. (This ab- °F to 300 °F. sorbance is obtained by approximately (5) The additive is manufactured 0.03 milligram solids permilliliter.) The from hops by an initial extraction and ultraviolet absorption spectrum of this fractionation using one or more of the solution exhibits the following charac- following solvents: Ethylene dichlo- teristics: An absorption peak at 253 ride, hexane, isopropyl alcohol, methyl millimicrons; no absorption peak at 325 alcohol, methylene chloride, trichloro- to 330 millimicrons; the absorbance at ethylene, and water; followed by 268 millimicrons does not exceed the isomerization by calcium chloride or absorbance at 272 millimicrons. magnesium chloride treatment in (ii) The boron content of the food ad- ethylene dichloride, methylene chlo- ditive does not exceed 310 parts per ride, or trichloroethylene and a further million (0.0310 percent), calculated as sequence of extractions and fraction- boron. ations using one or more of the sol- (2) The additive is manufactured vents set forth in this paragraph. Resi- from hops by a sequence of extractions dues of the solvents in the modified and fractionations, using benzene, light hop extract shall not exceed 125 parts petroleum spirits, and methyl alcohol per million of hexane; 150 parts per mil- as solvents, followed by isomerization lion of ethylene dichloride, methylene by potassium carbonate treatment. chloride, or trichloroethylene; or 250 Residues of solvents in the modified parts per million of isopropyl alcohol hop extract shall not exceed 1.0 part or methyl alcohol. per million of benzene, 1.0 part per mil- (6) The additive is manufactured lion of light petroleum spirits, and 250 from hops by an initial extraction and parts per million of methyl alcohol. fractionation using one or more of the The light petroleum spirits and ben- solvents listed in paragraph (b)(5) of zene solvents shall comply with the this section followed by: Hydro- specifications in § 172.250 except that genation using palladium as a catalyst the boiling point range for light petro- in methyl alcohol, ethyl alcohol, or leum spirits is 150 °F–300 °F. isopropyl alcohol acidified with hydro- (3) The additive is manufactured chloric or sulfuric acid; oxidation with from hops by a sequence of extractions peracetic acid; isomerization by cal- and fractionations, using methylene cium chloride or magnesium chloride chloride, hexane, and methyl alcohol as treatment in ethylene dichloride, solvents, followed by isomerization by methylene chloride, or trichloro- sodium hydroxide treatment. Residues ethylene (alternatively, the hydro- of the solvents in the modified hop ex- genation and isomerization steps may tract shall not exceed 5 parts per mil- be performed in reverse order); and a lion of methylene chloride, 25 parts per further sequence of extractions and million of hexane, and 100 parts per fractionations using one or more of the million of methyl alcohol. solvents listed in paragraph (b)(5) of (4) The additive is manufactured this section. The additive shall meet from hops by a sequence of extractions the residue limitations as prescribed in and fractionations, using benzene, light paragraph (b)(5) of this section. petroleum spirits, methyl alcohol, n- (7) The additive is manufactured butyl alcohol, and ethyl acetate as sol- from hops as set forth in paragraph

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(b)(6) of this section followed by reduc- § 172.585 Sugar beet extract flavor tion with sodium borohydride in aque- base. ous alkaline methyl alcohol, and a se- Sugar beet extract flavor base may quence of extractions and fraction- be safely used in food in accordance ations using one or more of the sol- with the provisions of this section. vents listed in paragraph (b)(5) of this (a) Sugar beet extract flavor base is section. The additive shall meet the the concentrated residue of soluble residue limitations as prescribed in sugar beet extractives from which paragraph (b)(5) of this section, and a sugar and glutamic acid have been re- boron content level not in excess of 300 covered, and which has been subjected parts per million (0.0300 percent), cal- to ion exchange to minimize the con- culated as boron. centration of naturally occurring trace (8) The additive is manufactured minerals. from hops as a nonisomerizable non- (b) It is used as a flavor in food. volatile hop resin by an initial extraction and fractionation using one or § 172.590 Yeast-malt sprout extract. more of the solvents listed in para- Yeast-malt sprout extract, as de- graph (b)(5) of this section followed by scribed in this section, may be safely a sequence of aqueous extractions and used in food in accordance with the fol- removal of nonaqueous solvents to less lowing prescribed conditions: than 0.5 percent. The additive is added (a) The additive is produced by par- to the wort before or during cooking in tial hydrolysis of yeast extract (de- the manufacture of beer. rived from Saccharomyces cereviseae, Saccharomyces fragilis, or Candida utilis) § 172.575 Quinine. using the sprout portion of malt barley Quinine, as the hydrochloride salt or as the source of enzymes. The additive ′ sulfate salt, may be safely used in food contains a maximum of 6 percent 5 nu- cleotides by weight. in accordance with the following condi- (b) The additive may be used as a fla- tions: vor enhancer in food at a level not in Uses Limitations excess of that reasonably required to produce the intended effect. In carbonated bev- Not to exceed 83 parts per million, as erages as a flavor. quinine. Label shall bear a promi- nent declaration of the presence of Subpart G—Gums, Chewing Gum quinine either by the use of the Bases and Related Substances word ‘‘quinine’’ in the name of the article or through a separate declaration. § 172.610 Arabinogalactan. Arabinogalactan may be safely used § 172.580 Safrole-free extract of sas- in food in accordance with the fol- safras. lowing conditions: (a) Arabinogalactan is a poly- The food additive safrole-free extract saccharide extracted by water from of sassafras may be safely used in ac- Western larch wood, having galactose cordance with the following prescribed units and arabinose units in the ap- conditions: proximate ratio of six to one. (a) The additive is the aqueous ex- (b) It is used in the following foods in tract obtained from the root bark of the minimum quantity required to the plant Sassafras albidum (Nuttall) produce its intended effect as an emul- Nees (Fam. Lauraceae). sifier, stabilizer, binder, or bodying (b) It is obtained by extracting the agent: Essential oils, nonnutritive bark with dilute alcohol, first concen- sweeteners, flavor bases, nonstandard- trating the alcoholic solution by vacu- ized dressings, and pudding mixes. um distillation, then diluting the concentrate with water and discarding the § 172.615 Chewing gum base. oily fraction. The food additive chewing gum base (c) The purified aqueous extract is may be safely used in the manufacture safrole-free. of chewing gum in accordance with the (d) It is used as a flavoring in food. following prescribed conditions:

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(a) The food additive consists of one used in amounts not to exceed those re- or more of the following substances quired to produce the intended physical that meet the specifications and limi- or other technical effect. tations prescribed in this paragraph,

MASTICATORY SUBSTANCES NATURAL (COAGULATED OR CONCENTRATED LATICES) OF VEGETABLE ORIGIN

Family Genus and species

Sapotaceae: Chicle ...... Manilkara zapotilla Gilly and Manilkara chicle Gilly. Chiquibul ...... Manilkara zapotilla Gilly. Crown gum ...... Manilkara zapotilla Gilly and Manilkara chicle Gilly. Gutta hang kang ...... Palaquium leiocarpum Boerl. and Palaquium oblongifolium Burck. Massaranduba balata (and the solvent-free Manilkara huberi (Ducke) Chevalier. resin extract of Massaranduba balata). Massaranduba chocolate ...... Manilkara solimoesensis Gilly. Nispero ...... Manilkara zapotilla Gilly and Manilkara chicle Gilly. Rosidinha (rosadinha) ...... Micropholis (also known as Sideroxylon) spp. Venezuelan chicle ...... Manilkara williamsii Standley and related spp. Apocynaceae: Jelutong ...... Dyera costulata Hook, F. and Dyera lowii Hook, F. Leche caspi (sorva) ...... Couma macrocarpa Barb. Rodr. Pendare ...... Couma macrocarpa Barb. Rodr. and Couma utilis (Mart.) Muell. Arg. Perillo ...... Couma macrocarpa Barb. Rodr. and Couma utilis (Mart.) Muell. Arg. Moraceae: Leche de vaca ...... Brosimum utile (H.B.K.) Pittier and Poulsenia spp.; also Lacmellea standleyi (Woodson), Monachino (Apocynaceae). Niger gutta ...... Ficus platyphylla Del. Tunu (tuno) ...... Castilla fallax Cook. Euphorbiaceae: Chilte ...... Cnidoscolus (also known as Jatropha) elasticus Lundell and Cnidoscolus tepiquensis (Cost. and Gall.) McVaugh. Natural rubber (smoked sheet and latex sol- Hevea brasiliensis. ids).

Synthetic Specifications

Butadiene-styrene rubber ...... Basic polymer. Isobutylene-isoprene copolymer (butyl rub- Do. ber). Paraffin ...... Synthesized by Fischer-Tropsch process from carbon monoxide and hydrogen which are catalytically converted to a mixture of paraffin hydrocarbon. Lower molecular weight fractions are removed by distillation. The residue is hydrogenated and further treated by percolation through activated charcoal. The product has a congealing point of 93°–99 °C as determined by ASTM method D938–71 (Reapproved 1981), ‘‘Standard Test Method for Con- gealing Point of Petroleum Waxes, Including Petrolatum,’’ a maximum oil content of 0.5 percent as determined by ASTM method D721–56T, ‘‘Ten- tative Method of Test for Oil Content of Petroleum Waxes,’’ and an absorptivity of less than 0.01 at 290 millimicrons in decahydronaphthalene at 88 °C as determined by ASTM method D2008–80, ‘‘Standard Test Method for Ultraviolet Absorbance and Absorptivity of Petroleum Products,’’ which are incorporated by reference. Copies may be obtained from the American So- ciety for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Ar- chives 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. Petroleum wax ...... Complying with § 172.886. Petroleum wax synthetic ...... Complying with § 172.888. Polyethylene ...... Molecular weight 2,000–21,000. Polyisobutylene ...... Minimum molecular weight 37,000 (Flory). Polyvinyl acetate ...... Molecular weight, minimum 2,000.

PLASTICIZING MATERIALS (SOFTENERS)

Glycerol ester of partially dimerized rosin ...... Having an acid number of 3–8, a minimum drop-softening point of 109 °C, and a color of M or paler. Glycerol ester of partially hydrogenated gum or Having an acid number of 3–10, a minimum drop-softening point of 79 °C, wood rosin. and a color of N or paler. Glycerol ester of polymerized rosin ...... Having an acid number of 3–12, a minimum melting-point of 80 °C, and a color of M or paler.

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MASTICATORY SUBSTANCES—Continued NATURAL (COAGULATED OR CONCENTRATED LATICES) OF VEGETABLE ORIGIN

Family Genus and species

Glycerol ester of gum rosin ...... Having an acid number of 5–9, a minimum drop-softening point of 88 °C, and a color of N or paler. The ester is purified by steam stripping. Glycerol ester of tall oil rosin ...... Having an acid number of 2–12, a softening point (ring and ball) of 80°–88 °C, and a color of N or paler. The ester is purified by steam stripping. Glycerol ester of wood rosin ...... Having an acid number of 3–9, a drop-softening point of 88 °C–96 °C, and a color of N or paler. The ester is purified by steam stripping. Lanolin ...... Methyl ester of rosin, partially hydrogenated ...... Having an acid number of 4–8, a refractive index of 1.5170–1.5205 at 20 °C, and a viscosity of 23–66 poises at 25 °C. The ester is purified by steam stripping. Pentaerythritol ester of partially hydrogenated Having an acid number of 7–18, a minimum drop-softening point of 102 °C, gum or wood rosin. and a color of K or paler. Pentaerythritol ester of gum or wood rosin ...... Having an acid number of 6–16, a minimum drop-softening point of 109 °C, and a color of M or paler. Rice bran wax ...... Complying with § 172.890. Stearic acid ...... Complying with § 172.860. Sodium and potassium stearates ...... Complying with § 172.863.

TERPENE RESINS

Synthetic resin ...... Consisting of polymers of apinene, bpinene, and/or dipentene; acid value less than 5, saponification number less than 5, and color less than 4 on the Gardner scale as measured in 50 percent mineral spirit solution. Natural resin ...... Consisting of polymers of a-pinene; softening point minimum 155 °C, determined by U.S.P. closed-capillary method, United States Pharmacopeia XX (1980) (page 961).

ANTIOXIDANTS

Butylated hydroxyanisole ...... Not to exceed antioxidant content of 0.1% when used alone or in any combination. Butylated hydroxytoluene ...... Do. Propyl gallate ...... Do.

MISCELLANEOUS

Sodium sulfate ...... Sodium sulfide ...... Reaction-control agent in synthetic polymer production.

(b) In addition to the substances list- § 172.620 Carrageenan. ed in paragraph (a) of this section, The food additive carrageenan may chewing gum base may also include be safely used in food in accordance substances generally recognized as safe with the following prescribed condi- in food. tions: (c) To assure safe use of the additive, (a) The food additive is the refined in addition to the other information re- hydrocolloid prepared by aqueous ex- quired by the act, the label and label- traction from the following members of ing of the food additive shall bear the the families Gigartinaceae and Solier- name of the additive, ‘‘chewing gum iaceae of the class Rodophyceae (red base.’’ As used in this paragraph, the seaweed): term ‘‘chewing gum base’’ means the manufactured or partially manufac- Chondrus crispus. tured nonnutritive masticatory sub- Chondrus ocellatus. stance comprised of one or more of the Eucheuma cottonii. ingredients named and so defined in Eucheuma spinosum. paragraph (a) of this section. Gigartina acicularis. Gigartina pistillata. [42 FR 14491, Mar. 15, 1977, as amended at 45 Gigartina radula. FR 56051, Aug. 22, 1980; 49 FR 5747, Feb. 15, Gigartina stellata. 1984; 49 FR 10105, Mar. 19, 1984; 66 FR 38153, July 23, 2001; 66 FR 53711, Oct. 24, 2001] (b) The food additive conforms to the following conditions:

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(1) It is a sulfated polysaccharide the § 172.626 Salts of carrageenan. dominant hexose units of which are ga- The food additive salts of carra- lactose and anhydrogalactose. geenan may be safely used in food in (2) Range of sulfate content: 20 per- accordance with the following pre- cent to 40 percent on a dry-weight scribed conditions: basis. (a) The food additive consists of car- (c) The food additive is used or in- rageenan, meeting the provisions of tended for use in the amount necessary § 172.620, modified by increasing the for an emulsifier, stabilizer, or thick- concentration of one of the naturally ener in foods, except for those stand- occurring salts (ammonium, calcium, ardized foods that do not provide for potassium, or sodium) of carrageenan such use. to the level that it is the dominant salt (d) To assure safe use of the additive, in the additive. the label and labeling of the additive (b) The food additive is used or in- shall bear the name of the additive, tended for use in the amount necessary carrageenan. for an emulsifier, stabilizer, or thickener in foods, except for those stand- § 172.623 Carrageenan with poly- ardized foods that do not provide for sorbate 80. such use. Carrageenan otherwise meeting the (c) To assure safe use of the additive, definition and specifications of § 172.620 the label and labeling of the additive (a) and (b) and salts of carrageenan shall bear the name of the salt of car- otherwise meeting the definition of rageenan that dominates the mixture § 172.626(a) may be safely produced with by reason of the modification, e.g., the use of polysorbate 80 meeting the ‘‘sodium carrageenan’’, ‘‘potassium specifications and requirements of carrageenan’’, etc. § 172.840 (a) and (b) in accordance with the following prescribed conditions: § 172.655 Furcelleran. (a) The polysorbate 80 is used only to The food additive furcelleran may be facilitate separation of sheeted carra- safely used in food in accordance with geenan and salts of carrageenan from the following prescribed conditions: drying rolls. (a) The food additive is the refined (b) The carrageenan and salts of car- hydrocolloid prepared by aqueous ex- rageenan contain not more than 5 per- traction of furcellaria fastigiata of the cent by weight of polysorbate 80, and class Rodophyceae (red seaweed). the final food containing the additives (b) The food additive conforms to the contains polysorbate 80 in an amount following: not to exceed 500 parts per million. (1) It is a sulfated polysaccharide the (c) The carrageenan and salts of car- dominant hexose units of which are ga- rageenan so produced are used only in lactose and anhydrogalactose. producing foods in gel form and only (2) Range of sulfate content: 8 per- for the purposes defined in §§ 172.620(c) cent to 19 percent, on a dry-weight and 172.626(b), respectively. basis. (d) The carrageenan and salts of car- (c) The food additive is used or in- rageenan so produced are not used in tended for use in the amount necessary foods for which standards of identity for an emulsifier, stabilizer, or thick- exist unless the standards provide for ener in foods, except for those stand- the use of carrageenan, or salts of car- ardized foods that do not provide for rageenan, combined with polysorbate such use. 80. (d) To assure safe use of the additive, (e) The carrageenan and salts of car- the label and labeling of the additive rageenan produced in accordance with shall bear the name of the additive, this section, and foods containing the furcelleran. same, in addition to the other requirements of the Act, are labeled to show § 172.660 Salts of furcelleran. the presence of polysorbate 80, and the The food additive salts of furcelleran label or labeling of the carrageenan may be safely used in food in accord- and salts of carrageenan so produced ance with the following prescribed con- bear adequate directions for use. ditions:

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(a) The food additive consists of fur- tion of 10-percent calcium chloride. A celleran, meeting the provisions of tough worm-like gel will form in- § 172.655, modified by increasing the stantly. concentration of one of the naturally (ii) To the 1-percent distilled water occurring salts (ammonium, calcium, solution prepared for identification potassium, or sodium) of furcelleran to test (i), 0.50 gram of sodium chloride is the level that it is the dominant salt in added. The solution is heated to 80 °C the additive. with stirring, held at 80 °C for 1 (b) The food additive is used or in- minute, and allowed to cool to room tended for use in the amount necessary temperature without stirring. A firm for an emulsifier, stabilizer, or thick- gel will form. ener in foods, except for those stand- (2) Residual isopropyl alcohol (IPA) ardized foods that do not provide for not to exceed 0.075 percent as deter- such use. mined by the procedure described in (c) To assure safe use of the additive, the ‘‘Gellan gum’’ monograph in the the label and labeling of the additive Food Chemicals Codex, 7th ed. (2010), shall bear the name of the salt of fur- pp. 425–426, which is incorporated by celleran that dominates the mixture by reference. The Director of the Office of reason of the modification, e.g., ‘‘so- the Federal Register approves this in- dium furcelleran’’, ‘‘potassium furcel- corporation by reference in accordance leran’’, etc. with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United § 172.665 Gellan gum. States Pharmacopeial Convention, The food additive gellan gum may be 12601 Twinbrook Pkwy., Rockville, MD safely used in food in accordance with 20852 (Internet address http:// the following prescribed conditions: www.usp.org). Copies may be examined (a) The additive is a high molecular at the Food and Drug Administration’s weight polysaccharide gum produced Main Library, 10903 New Hampshire from Pseudomonas elodea by a pure cul- Ave., Bldg. 2, Third Floor, Silver ture fermentation process and purified Spring, MD 20993, 301–796–2039, or at the by recovery with isopropyl alcohol. It National Archives and Records Admin- is composed of tetrasaccharide repeat istration (NARA). For information on units, each containing one molecule of the availability of this material at rhamnose and glucuronic acid, and two NARA, call 202–741–6030 or go to: http:// molecules of glucose. The glucuronic www.archives.gov/federal-register/cfr/ibr- acid is neutralized to a mixed potas- locations.html. sium, sodium, calcium, and magnesium (e) The additive is used or intended salt. The polysaccharide may contain for use in accordance with current good acyl (glyceryl and acetyl) groups as the manufacturing practice as a stabilizer O-glycosidically linked esters. and thickener as defined in § 170.3(o)(28) (b) The strain of P. elodea is non- of this chapter. The additive may be pathogenic and nontoxic in man and used in foods where standards of iden- animals. tity established under section 401 of (c) The additive is produced by a the Federal Food, Drug, and Cosmetic process that renders it free of viable Act do not preclude such use. cells of P. elodea. (f) To assure safe use of the additive: (d) The additive meets the following specifications: (1) The label of its container shall (1) Positive for gellan gum when sub- bear, in addition to other information jected to the following identification required by the Federal Food, Drug, tests: and Cosmetic Act, the name of the ad- (i) A 1-percent solution is made by ditive and the designation ‘‘food hydrating 1 gram of gellan gum in 99 grade’’. milliliters of distilled water. The mix- (2) The label or labeling of the food ture is stirred for about 2 hours, using additive container shall bear adequate a motorized stirrer and a propeller- directions for use. type stirring blade. A small amount of [55 FR 39614, Sept. 28, 1990, as amended at 57 the above solution is drawn into a wide FR 55445, Nov. 25, 1992; 64 FR 1758, Jan. 12, bore pipet and transferred into a solu- 1999; 78 FR 71463, Nov. 29, 2013]

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§ 172.695 Xanthan gum. without agitation as before. Formation of a gel on cooling indicates that the sample is a The food additive xanthan gum may gelling polysaccharide and not xanthan gum. be safely used in food in accordance Record the sample as ‘‘positive’’ for xan- with the following prescribed condi- than gum if a firm, rubbery gel forms in the tions: presence of locust bean gum but not in its (a) The additive is a polysaccharide absence. Record the sample as ‘‘negative’’ for gum derived from Xanthomonas xanthan gum if no gel forms or if a soft or campestris by a pure-culture fermenta- brittle gel forms both with locust bean gum and in a 1 percent solution of the sample tion process and purified by recovery (containing no locust bean gum). with isopropyl alcohol. It contains D- glucose, D-mannose, and D-glucuronic (4) Positive for xanthan gum when acid as the dominant hexose units and subjected to the following procedure: is manufactured as the sodium, potassium, or calcium salt. PYRUVIC ACID TEST (b) The strain of Xanthomonas Pipet 10 milliliters of an 0.6 percent solu- campestris is nonpathogenic and tion of the polysaccharide in distilled water nontoxic in man or other animals. (60 milligrams of water-soluble gum) into a (c) The additive is produced by a 50-milliliter flask equipped with a standard process that renders it free of viable taper glass joint. Pipet in 20 milliliters of 1N hydrochloric acid. Weigh the flask. Reflux cells of Xanthomonas campestris. the mixture for 3 hours. Take precautions to (d) The additive meets the following avoid loss of vapor during the refluxing. Cool specifications: the solution to room temperature. Add dis- (1) Residual isopropyl alcohol not to tilled water to make up any weight loss from exceed 750 parts per million. the flask contents. (2) An aqueous solution containing 1 Pipet 1 milliliter of a 2,4-dinitrophenyl- percent of the additive and 1 percent of hydrazine reagent (0.5 percent in 2N hydro- potassium chloride stirred for 2 hours chloric acid) into a 30-milliliter separatory funnel followed by a 2-milliliter aliquot (4 has a minimum viscosity of 600 centi- milligrams of water-soluble gum) of the poises at 75 °F, as determined by polysaccharide hydrolyzate. Mix and allow Brookfield Viscometer, Model LVF (or the reaction mixture to stand at room tem- equivalent), using a No. 3 spindle at 60 perature for 5 minutes. Extract the mixture r.p.m., and the ratio of viscosities at 75 with 5 milliliters of ethyl acetate. Discard °F and 150 °F is in the range of 1.02 to the aqueous layer. 1.45. Extract the hydrazone from the ethyl acetate with three 5 milliliter portions of 10 per- (3) Positive for xanthan gum when cent sodium carbonate solution. Dilute the subjected to the following procedure: combined sodium carbonate extracts to 100 milliliters with additional 10 percent sodium LOCUST BEAN GUM GEL TEST carbonate in a 10-milliliter volumetric flask. Measure the optical density of the sodium Blend on a weighing paper or in a weighing carbonate solution at 375 millimicrons. pan 1.0 gram of powdered locust bean gum Compare the results with a curve of the op- with 1.0 gram of the powdered polysaccharide tical density versus concentration of an au- to be tested. Add the blend slowly (approxi- thentic sample of pyruvic acid that has been mately 1⁄2 minute) at the point of maximum run through the procedure starting with the agitation to a stirred solution of 200 milli- preparation of the hydrazone. liters of distilled water previously heated to Record the percent by weight of pyruvic 80 °C in a 400-milliliter beaker. Continue me- acid in the test polysaccharide. Note ‘‘posi- chanical stirring until the mixture is in solu- tive’’ for xanthan gum if the sample contains tion, but stir for a minimum time of 30 min- more than 1.5 percent of pyruvic acid and utes. Do not allow the water temperature to ‘‘negative’’ for xanthan gum if the sample drop below 60 °C. contains less than 1.5 percent of pyruvic acid Set the beaker and its contents aside to by weight. cool in the absence of agitation. Allow a minimum time of 2 hours for cooling. Exam- (e) The additive is used or intended ine the cooled beaker contents for a firm for use in accordance with good manu- rubbery gel formation after the temperature facturing practice as a stabilizer, emul- ° drops below 40 C. sifier, thickener, suspending agent, In the event that a gel is obtained, make up a 1 percent solution of the polysaccharide bodying agent, or foam enhancer in to be tested in 200 milliliters of distilled foods for which standards of identity water previously heated to 80 °C (omit the lo- established under section 401 of the Act cust bean gum). Allow the solution to cool do not preclude such use.

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(f) To assure safe use of the additive: ber of moles of ethylene oxide reacted to (1) The label of its container shall produce any product that is a component of bear, in addition to other information the blend shall be in the range of 4–14 or 30– required by the Act, the name of the 70. additive and the designation ‘‘food a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]- grade’’. omega-hydroxypoly(oxyethylene) produced (2) The label or labeling of the food by the condensation of 1 mole of p-(1,1,3,3- tetramethylbutyl) phenol with 1 mole of additive container shall bear adequate ethylene oxide. directions for use. Sodium acrylate and acrylamide copolymer with a minimum average molecular Subpart H—Other Specific Usage weight of 10,000,000 in which 30 percent of the Additives polymer is comprised of acrylate units and 70 percent acrylamide units, for use as a drift § 172.710 Adjuvants for pesticide use control agent in herbicide formulations ap- dilutions. plied to crops at a level not to exceed 0.5 The following surfactants and related ounces of the additive per acre. adjuvants may be safely added to pes- § 172.712 1,3-Butylene glycol. ticide use dilutions by a grower or ap- plicant prior to application to the The food additive 1,3-butylene glycol growing crop: (CAS Reg. No. 107–88–0) may be safely used in food in accordance with the fol- n-Alkyl (C -C ) amine acetate, where the 8 18 lowing prescribed conditions: alkyl groups (C8-C18) are derived from coconut oil, as a surfactant in emulsifier blends (a) It is prepared by the aldol con- at levels not in excess of 5 percent by weight densation of acetaldehyde followed by of the emulsifier blends that are added to catalytic hydrogenation. herbicides for application to corn and sor- (b) The food additive shall conform ghum. to the identity and specifications of Di-n-alkyl (C8-C18) dimethyl ammonium chloride, where the alkyl groups (C8-C18) are the Food Chemicals Codex, 7th ed. derived from coconut oil, as surfactants in (2010), p. 126, which is incorporated by emulsifier blends at levels not in excess of 5 reference. The Director of the Office of percent by weight of emulsifier blends that the Federal Register approves this in- are added to herbicides for application to corn or sorghum. corporation by reference in accordance Diethanolamide condensate based on a with 5 U.S.C. 552(a) and 1 CFR part 51. mixture of saturated and unsaturated soy- You may obtain copies from the United bean oil fatty acids (C16-C18) as a surfactant States Pharmacopeial Convention, in emulsifier blends that are added to the 12601 Twinbrook Pkwy., Rockville, MD herbicide atrazine for application to corn. 20852 (Internet address http:// Diethanolamide condensate based on www.usp.org). Copies may be examined stripped coconut fatty acids (C10 C18) as a surfactant in emulsifier blends that are at the Food and Drug Administration’s added to the herbicide atrazine for applica- Main Library, 10903 New Hampshire tion to corn. Ave., Bldg. 2, Third Floor, Silver a-(p-Dodecylphenyl)-omega-hydroxypoly Spring, MD 20993, 301–796–2039, or at the (oxyethylene) produced by the condensation National Archives and Records Admin- of 1 mole of dodecylphenol (dodecyl group is a proplyene tetramer isomer) with an aver- istration (NARA). For information on age of 4–14 or 30–70 moles of ethylene oxide; the availability of this material at if a blend of products is used, the average NARA, call 202–741–6030 or go to: http:// number of moles of ethylene oxide reacted to www.archives.gov/federal-register/cfr/ibr- produce any product that is a component of locations.html. the blend shall be in the range of 4–14 or 30– 70. (c) It is used in the manufacture of Ethylene dichloride. sausage casings as a formulation aid as Polyglyceryl phthalate ester of coconut oil defined in § 170.3(o)(14) of this chapter fatty acids. and as a processing aid as defined in a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]- § 170.3(o)(24) of this chapter. omega-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-(1,1,3,3- [62 FR 26228, May 13, 1997, as amended at 78 tetramethylbutyl) phenol with an average of FR 14664, Mar. 7, 2013; 78 FR 71463, Nov. 29, 4–14 or 30–70 moles of ethylene oxide; if a 2013] blend of products is used, the average num-

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§ 172.715 Calcium lignosulfonate. federallregister/ Calcium lignosulfonate may be safely codeloflfederallregulations/ used in or on food, subject to the provi- ibrllocations.html. sions of this section. (2) The maximum iodine value is 3.0, (a) Calcium lignosulfonate consists of as determined by A.O.C.S. method Cd sulfonated lignin, primarily as calcium 1–25, ‘‘Iodine Value of Fats and Oils and sodium salts. Wijs Method,’’ revised 1993, which is in- (b) It is used in an amount not to ex- corporated by reference in accordance ceed that reasonably required to ac- with 5 U.S.C. 552(a) and 1 CFR part 51. complish the intended physical or tech- The availability of this incorporation nical effect when added as a dispersing by reference is given in paragraph agent and stabilizer in pesticides for (b)(1) of this section. preharvest or postharvest application (3) The heavy metals (as Pb) content to bananas. cannot be more than 10 parts per million, as determined by the ‘‘Heavy Met- § 172.720 Calcium lactobionate. als Test,’’ of the ‘‘Food Chemicals The food additive calcium Codex,’’ 4th ed. (1996), pp. 760–761, Meth- lactobionate may be safely used in food od II (with a 2-gram sample and 20 in accordance with the following pre- microgram of lead ion in the control), scribed conditions: which is incorporated by reference in (a) The food additive is the calcium accordance with 5 U.S.C. 552(a) and 1 salt of lactobionic acid (4-(b,D- CFR part 51. Copies are available from galactosido)-D-gluconic acid) produced the National Academy Press, Box 285, by the oxidation of lactose. 2101 Constitution Ave. NW., Wash- (b) It is used or intended for use as a ington, DC 20055 (Internet address firming agent in dry pudding mixes at http://www.nap.edu), or may be exam- a level not greater than that required ined at the Food and Drug Administra- to accomplish the intended effect. tion’s Main Library, 10903 New Hamp- shire Ave., Bldg. 2, Third Floor, Silver § 172.723 Epoxidized soybean oil. Spring, MD 20993, 301–796–2039, or at the Epoxidized soybean oil may be safely National Archives and Records Admin- used in accordance with the following istration (NARA). For information on prescribed conditions: the availability of this material at (a) The additive is prepared by react- NARA, call 202–741–6030, or go to: http:// ing soybean oil in toluene with hydro- www.archives.gov/federallregister/ gen peroxide and formic acid. codeloflfederallregulations/ (b) It meets the following specifica- ibrllocations.html. tions: (c) The additive is used as a halogen (1) Epoxidized soybean oil contains stabilizer in brominated soybean oil at oxirane oxygen, between 7.0 and 8.0 per- a level not to exceed 1 percent. cent, as determined by the American Oil Chemists’ Society (A.O.C.S.) meth- [60 FR 32903, June 26, 1995, as amended at 64 od Cd 9–57, ‘‘Oxirane Oxygen,’’ re- FR 1759, Jan. 12, 1999; 78 FR 14665, Mar. 7, approved 1989, which is incorporated by 2013; 81 FR 5591, Feb. 3, 2016] reference in accordance with 5 U.S.C § 172.725 Gibberellic acid and its po- 552(a) and 1 CFR part 51. Copies are tassium salt. available from the American Oil Chem- ists’ Society, P. O. Box 3489, Cham- The food additives gibberellic acid paign, IL 61826–3489, or may be exam- and its potassium salt may be used in ined at the Office of Food Additive the malting of barley in accordance Safety (HFS–200), Center for Food Safe- with the following prescribed condi- ty and Applied Nutrition, Food and tions: Drug Administration, 5001 Campus Dr., (a) The additives meet the following College Park, MD 20740, 240–402–1200, or specifications: at the National Archives and Records (1) The gibberellic acid is produced Administration (NARA). For informa- by deep-culture fermentation of a suit- tion on the availability of this mate- able nutrient medium by a strain of rial at NARA, call 202–741–6030, or go Fusarium moniliforme or a selection of to: http://www.archives.gov/ this culture.

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(2) The gibberellic acid produced is of be used in the production of distilled 80 percent purity or better. spirits only’’, whichever is appropriate. (3) The empirical formula of gibberellic acid is represented by § 172.730 Potassium bromate. C19H22O6. The food additive potassium bromate (4) Potassium gibberellate is the po- may be safely used in the malting of tassium salt of the specified gibberellic barley under the following prescribed acid. conditions: (5) The potassium gibberellate is of 80 (a)(1) It is used or intended for use in percent purity or better. the malting of barley under conditions (6) The gibberellic acid or potassium whereby the amount of the additive gibberellate may be diluted with sub- present in the malt from the treatment stances generally recognized as safe in does not exceed 75 parts per million of foods or with salts of fatty acids con- bromate (calculated as Br), and the forming to § 172.863. treated malt is used only in the pro- (b) They are used or intended for use duction of fermented malt beverages or in the malting of barley under condi- distilled spirits. tions whereby the amount of either or (2) The total residue of inorganic bro- both additives present in the malt is mides in fermented malt beverages, re- not in excess of 2 parts per million ex- sulting from the use of the treated pressed as gibberellic acid, and the malt plus additional residues of inor- treated malt is to be used in the pro- ganic bromides that may be present duction of fermented malt beverages or from uses in accordance with other reg- distilled spirits only, whereby the fin- ulations in this chapter promulgated ished distilled spirits contain none and under sections 408 and/or 409 of the act, the finished malt beverage contains does not exceed 25 parts per million of not more than 0.5 part per million of bromide (calculated as Br). No toler- gibberellic acid. ance is established for bromide in dis- (c) To insure the safe use of the food tilled spirits because there is evidence additives the label of the package shall that inorganic bromides do not pass bear, in addition to the other informa- over in the distillation process. tion required by the Act: (b) To assure safe use of the additive, (1) The name of the additive, the label or labeling of the food addi- ‘‘gibberellic acid’’ or ‘‘potassium tive shall bear, in addition to the other gibberellate’’, whichever is appro- information required by the Act, the priate. following: (2) An accurate statement of the con- (1) The name of the additive. centration of the additive contained in (2) Adequate directions for use. the package. (c) To assure safe use of the additive, (3) Adequate use directions to provide the label or labeling of the treated not more than 2 parts per million of malt shall bear, in addition to other in- gibberellic acid in the finished malt. formation required by the Act, the (4) Adequate labeling directions to statement, ‘‘Brewer’s Malt—To be used provide that the final malt is properly in the production of fermented malt labeled as described in paragraph (d) of beverages only’’, or ‘‘Distiller’s Malt— this section. To be used in the production of dis- (d) To insure the safe use of the addi- tilled spirits only’’, whichever is the tive the label of the treated malt shall case. bear, in addition to the other information required by the Act, the state- § 172.735 Glycerol ester of rosin. ments: Glycerol ester of wood rosin, gum (1) ‘‘Contains not more than 2 parts rosin, or tall oil rosin may be safely per million lll’’, the blank being used in food in accordance with the fol- filled in with the words ‘‘gibberellic lowing prescribed conditions: acid’’ or ‘‘potassium gibberellate’’, (a) It has an acid number of 3 to 9, a whichever is appropriate; and drop-softening point of 88 to 96 °C; and (2) ‘‘Brewer’s malt—To be used in the a color of N or paler as determined in production of fermented malt bev- accordance with Official Naval Stores erages only’’ or ‘‘Distiller’s malt—To Standards of the United States. It is

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purified by countercurrent steam dis- 56, as determined by the methods enti- tillation or steam stripping. tled ‘‘Acid Value,’’ p. 1220 and (b) It is used to adjust the density of ‘‘Hydroxyl Value,’’ p. 1223, respec- citrus oils used in the preparation of tively, in the Food Chemicals Codex, beverages whereby the amount of the 7th ed. (2010), which is incorporated by additive does not exceed 100 parts per reference. The Director of the Office of million of the finished beverage. the Federal Register approves this in- [42 FR 14491, Mar. 15, 1977, as amended at 70 corporation by reference in accordance FR 15758, Mar. 29, 2005; 72 FR 46896, Aug. 22, with 5 U.S.C. 552(a) and 1 CFR part 51. 2007] You may obtain copies from the United States Pharmacopeial Convention, § 172.736 Glycerides and polyglycides 12601 Twinbrook Pkwy., Rockville, MD of hydrogenated vegetable oils. 20852 (Internet address http:// The food additive glycerides and www.usp.org). Copies may be examined polyglycides of hydrogenated vegetable at the Food and Drug Administration’s oils may be safely used in food in ac- Main Library, 10903 New Hampshire cordance with the following prescribed Ave., Bldg. 2, Third Floor, Silver conditions: Spring, MD 20993, 301–796–2039, or at the (a) The additive is manufactured by National Archives and Records Admin- heating a mixture of hydrogenated oils istration (NARA). For information on of vegetable origin and polyethylene the availability of this material at glycol in the presence of an alkaline NARA, call 202–741–6030 or go to: http:// catalyst followed by neutralization www.archives.gov/federal-register/cfr/ibr- with any acid that is approved or is locations.html. generally recognized as safe for this (3) Lead, not greater than 0.1 mg/kg use to yield the finished product. as determined by the American Oil (b) The additive consists of a mixture Chemists’ Society (A.O.C.S.) method of mono-, di- and tri-glycerides and Ca 18c–91, ‘‘Determination of Lead by polyethylene glycol mono- and di- Direct Graphite Furnace Atomic Ab- esters of fatty acids (polyglycides) of sorption Spectrophotometry,’’ updated hydrogenated vegetable oils and meets 1995, and incorporated by reference in the following specifications: accordance with 5 U.S.C. 552(a) and 1 (1) Total ester content, greater than CFR part 51. Copies are available from 90 percent as determined by a method American Oil Chemists’ Society, P. O. entitled ‘‘Determination of Esterified Box 3489, Champaign, IL 61826–3489, or Glycerides and Polyoxyethylene may be examined at the Food and Drug Glycols,’’ approved November 16, 2001, Administration’s Main Library, 10903 printed by Gattefosse S.A.S., and in- New Hampshire Ave., Bldg. 2, Third corporated by reference. The Director Floor, Silver Spring, MD 20993, 301–796– of the Office of the Federal Register 2039, or at the National Archives and approves this incorporation by ref- Records Administration (NARA). For erence in accordance with 5 U.S.C. information on the availability of this 552(a) and 1 CFR part 51. You may ob- material at NARA, call 202–741–6030, or tain a copy from the Office of Food Ad- go to http://www.archives.gov/ ditive Safety, 5001 Campus Dr., College federallregister/ Park, MD 20740 or you may examine a codeloflfederallregulations/ copy at the Food and Drug Administra- ibrllocations.html. tion’s Main Library, 10903 New Hamp- (4) 1,4-Dioxane, not greater than 10 shire Ave., Bldg. 2, Third Floor, Silver milligrams per kilogram (mg/kg), and Spring, MD 20993, 301–796–2039, or at the ethylene oxide, not greater than 1 mg/ National Archives and Records Admin- kg, as determined by a gas istration (NARA). For information on chromatographic method entitled the availability of this material at ‘‘Determination of Ethylene Oxide and NARA, call 202–741–6030, or go to http:// 1,4-Dioxane by Headspace Gas Chroma- www.archives.gov/federallregister/ tography,’’ approved November 5, 1998, codeloflfederallregulations/ printed by Gattefosse S.A.S., and in- ibrllocations.html. corporated by reference in accordance (2) Acid value, not greater than 2, with 5 U.S.C. 552(a) and 1 CFR part 51; and hydroxyl value, not greater than see paragraph (b)(1) of this section for

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availability of the incorporation by (b) The additive meets the following reference. specifications: (c) The additive is used or intended Acid number 50–150. for use as an excipient in dietary sup- Hydroxyl number 15–50. plement tablets, capsules, and liquid Succinated ester content 45–75 percent. formulations that are intended for ingestion in daily quantities measured in (c) The additive is used or intended drops or similar small units of meas- for use as an emulsifier in or with ure. shortenings and edible oils intended for use in cakes, cake mixes, fillings, [71 FR 12620, Mar. 13, 2006, as amended at 78 icings, pastries, and toppings, in ac- FR 71463, Nov. 29, 2013; 81 FR 5591, Feb. 3, cordance with good manufacturing 2016] practice.

§ 172.755 Stearyl monoglyceridyl cit- § 172.770 Ethylene oxide polymer. rate. The polymer of ethylene oxide may The food additive stearyl be safely used as a foam stabilizer in monoglyceridyl citrate may be safely fermented malt beverages in accord- used in food in accordance with the fol- ance with the following conditions. lowing provisions: (a) It is the polymer of ethylene (a) The additive is prepared by con- oxide having a minimum viscosity of trolled chemical reaction of the fol- 1,500 centipoises in a 1 percent aqueous lowing: solution at 25 °C. Reactant Limitations (b) It is used at a level not to exceed 300 parts per million by weight of the Citric acid ...... fermented malt beverage. Monoglycerides of fatty Prepared by the glycerolysis of ed- (c) The label of the additive bears di- acids. ible fats and oils or derived from fatty acids conforming with rections for use to insure compliance § 172.860. with paragraph (b) of this section. Stearyl alcohol...... Derived from fatty acids conforming with § 172.860, or de- § 172.775 Methacrylic acid- rived synthetically in conformity divinylbenzene copolymer. with § 172.864. Methacrylic acid-divinylbenzene co- (b) The additive stearyl polymer may be safely used in food in monoglyceridyl citrate, produced as accordance with the following pre- described under paragraph (a) of this scribed conditions: section, meets the following specifica- (a) The additive is produced by the tions: polymerization of methacrylic acid and divinylbenzene. The divinylbenzene Acid number 40 to 52. functions as a cross-linking agent and Total citric acid 15 to 18 percent. constitutes a minimum of 4 percent of Saponification number 215–255. the polymer. (c) The additive is used or intended (b) Aqueous extractives from the ad- for use as an emulsion stabilizer in or ditive do not exceed 2 percent (dry with shortenings containing emulsi- basis) after 24 hours at 25 °C. fiers. (c) The additive is used as a carrier of vitamin B12 in foods for special dietary § 172.765 Succistearin (stearoyl pro- use. pylene glycol hydrogen succinate). The food additive succistearin (ste- § 172.780 Acacia (gum arabic). aroyl propylene glycol hydrogen succi- The food additive may be safely used nate) may be safely used in food in ac- in food in accordance with the fol- cordance with the following prescribed lowing prescribed conditions: conditions: (a) Acacia (gum arabic) is the dried (a) The additive is the reaction prod- gummy exudate from stems and uct of succinic anhydride, fully hydro- branches of trees of various species of genated vegetable oil (predominantly the genus Acacia, family Leguminosae. C16 or C18 fatty acid chain length), and (b) The ingredient meets the speci- propylene glycol. fications of the Food Chemicals Codex,

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8th ed. (2012), p. 516, which is incor- Hampshire Ave., Bldg. 2, 3d Floor, Sil- porated by reference. The Director of ver Spring, MD 20993, 301–796–2039, or at the Office of the Federal Register ap- the National Archives and Records Ad- proves this incorporation by reference ministration (NARA). For information in accordance with 5 U.S.C. 552(a) and 1 on the availability of this material at CFR part 51. You may obtain copies NARA, call 202–741–6030, or go to: http:// from the United States Pharmacopeial www.archives.gov/federal-register/cfr/ibr- Convention, 12601 Twinbrook Pkwy., locations.html. Rockville, MD 20852 (Internet address: (c) The ingredient is used in food in http://www.usp.org). Copies may be ex- accordance with good manufacturing amined at the Food and Drug Adminis- practices under the following condi- tration’s Main Library, 10903 New tions:

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Beverages, alcoholic ...... 20.0 ...... Thickener, emulsifier, or stabilizer. Breakfast cereals, § 170.3(n)(4) of this chapter ..... 6.0 ...... Dietary fiber; emulsifier and emulsifier salt; flavoring agent and adjuvant; formulation aid; processing aid; stabilizer and thickener; surface-finishing agent; texturizer. Cakes, brownies, pastries, biscuits, muffins, and 3.0 ...... Do. cookies. Grain-based bars (e.g., breakfast bars, granola 35.0 ...... Do. bars, rice cereal bars). Soups and soup mixes, § 170.3(n)(40) of this 2.5 ...... Do. chapter, except for soups and soup mixes containing meat or poultry that are subject to regulation by the U.S. Department of Agriculture under the Federal Meat Inspection Act or the Poultry Products Inspection Act. Food categories listed in § 184.1330 of this chap- Levels prescribed in Dietary fiber. ter, except for meat, poultry, and foods for § 184.1330 of this which standards of identity established under chapter. section 401 of the Federal Food, Drug, and Cosmetic Act preclude the use of acacia.

[70 FR 8034, Feb. 17, 2005, as amended at 78 (b) Specifications. (1) The additive FR 71464, Nov. 29, 2013; 78 FR 73437, Dec. 6, achieves a positive lytic result (OD600 2013] ≤0.06) when tested against any of the following L. monocytogenes isolates § 172.785 Listeria-specific available from American Type Culture bacteriophage preparation. Collection (ATCC): ATCC 35152 The additive may be safely used as an (serogroup 1/2a), ATCC 19118 (serogroup antimicrobial agent specific for Listeria 4b), and ATCC 15313 (serogroup 1/2b). monocytogenes (L. monocytogenes) in ac- The analytical method for determining cordance with the following conditions: the potency of the additive entitled (a) Identity. (1) The additive consists ‘‘Determination of Potency of LMP– of a mixture of equal proportions of six 102 TM,’’ dated October 9, 2003, and different individually purified lytic- printed by Intralytix, Inc., is incor- type (lacking lysogenic activity) porated by reference. The Director of bacteriophages (phages) specific the Office of the Federal Register ap- against L. monocytogenes. proves this incorporation by reference (2) Each phage is deposited at, and in accordance with 5 U.S.C. 552(a) and 1 assigned an identifying code by, a sci- CFR part 51. You may obtain a copy entifically-recognized culture collec- from the Office of Food Additive Safety tion center, and is made available to (HFS–200), Food and Drug Administra- FDA upon request. tion’s Main Library, 10903 New Hamp- (3) The additive is produced from one shire Ave., Bldg. 2, Third Floor, Silver or more cell cultures of L. Spring, MD 20993, 301–796–2039, or you monocytogenes in a safe and suitable nu- may examine a copy at the Center for trient medium. Food Safety and Applied Nutrition’s

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Library, 5001 Campus Dr., College 11, 2003, and printed by Intralytix, Inc., Park, MD 20740, or at the National Ar- is incorporated by reference. Copies are chives and Records Administration available at locations cited in para- (NARA). For information on the avail- graph (b)(1) of this section. ability of this material at NARA, call (7) Total organic carbon (TOC) is less 202–741–6030, or go to: http:// than or equal to 36 mg/kg. The analyt- www.archives.gov/federallregister/ ical method for determining TOC enti- codeloflfederallregulations/ tled ‘‘Determination of Total Organic ibrllocations.html. Carbon by Automated Analyzer,’’ dated (2) The mean phage titer of each March 30, 2001, and printed by monophage in the additive is 1 × 109 Intralytix, Inc., is incorporated by ref- plaque forming units (PFU)/ml. The an- erence. Copies are available at loca- alytical method for determining phage tions cited in paragraph (b)(1) of this titer entitled ‘‘Method to Determine section. Lytic Activity/Phage Titer,’’ dated No- (c) Conditions of use. The additive is vember 6, 2001, and printed by used in accordance with current good Intralytix, Inc., is incorporated by ref- manufacturing practice to control L. erence. Copies are available at loca- monocytogenes by direct application to tions cited in paragraph (b)(1) of this meat and poultry products that comply section. with the ready-to-eat definition in 9 (3) The phages present in the prepara- CFR 430.1. Current good manufacturing tion must not contain a functional por- practice is consistent with direct spray tion of any of the toxin-encoding se- application of the additive at a rate of quences described in 40 CFR 725.421(d). approximately 1 mL of the additive per No sequences derived from genes en- 500 cm2 product surface area. coding bacterial 16S ribosomal RNA [71 FR 47731, Aug. 18, 2006, as amended at 81 are present in the complete genomic FR v5591, Feb. 3, 2016] sequence of the phages. (4) L. monocytogenes toxin, Subpart I—Multipurpose Additives listeriolysin O (LLO), is not greater than 5 hemolytic units (HU)/ml. The § 172.800 Acesulfame potassium. analytical method for determining Acesulfame potassium (CAS Reg. No. LLO entitled ‘‘Quantitation of 55589–62–3), also known as acesulfame Listeriolysin O Levels in LMP–102 TM,’’ K, may be safely used as a general-pur- dated September 27, 2004, and printed pose sweetener and flavor enhancer in by Intralytix, Inc., is incorporated by foods generally, except in meat and reference. Copies are available at loca- poultry, in accordance with current tions cited in paragraph (b)(1) of this good manufacturing practice and in an section. amount not to exceed that reasonably (5) The additive is negative for L. required to accomplish the intended monocytogenes. The modified version of technical effect in foods for which the U.S. Department of Agriculture’s standards of identity established under method for determining L. section 401 of the Federal Food, Drug, monocytogenes entitled ‘‘LMP–102 TM and Cosmetic Act do not preclude such Listeria monocytogenes Sterility Test- use, under the following conditions: ing,’’ dated May 24, 2004, and printed by (a) Acesulfame potassium is the po- Intralytix, Inc., is incorporated by ref- tassium salt of 6-methyl-1,2,3- erence. Copies are available at loca- oxathiazine-4(3H)-one-2,2-dioxide. tions cited in paragraph (b)(1) of this (b) The additive meets the following section. specifications: (6) The additive is negative for gram- (1) Purity is not less than 99 percent positive and gram-negative bacteria on a dry basis. The purity shall be de- capable of growing in commonly used termined by a method titled microbiological media (e.g., Luria- ‘‘Acesulfame Potassium Assay,’’ which Bertani (LB) medium), including Esch- is incorporated by reference. Copies are erichia coli, Salmonella species and available from the Center for Food coagulase-positive Staphylococci, as de- Safety and Applied Nutrition (HFS– termined by the ‘‘Method to Determine 200), Food and Drug Administration, Microbial Contamination,’’ dated July 5001 Campus Dr., College Park, MD

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20740, or available for inspection at the drogen peroxide equivalent per 100 National Archives and Records Admin- grams of the additive, plus carrier, for istration (NARA). For information on use in flour maturing and bleaching; or the availability of this material at (2) approximately 0.75 gram of hydro- NARA, call 202–741–6030, or go to: http:// gen peroxide equivalent per 100 grams www.archives.gov/federallregister/ of the additive, plus carrier, for use in codeloflfederallregulations/ dough conditioning. ibrllocations.html. (c) It is used or intended for use: (1) (2) Fluoride content is not more than In maturing and bleaching of flour in a 30 milligrams per kilogram, as deter- quantity not more than sufficient for mined by method III of the Fluoride such effect; and (2) as a dough-condi- Limit Test of the Food Chemicals tioning agent in bread and roll produc- Codex, 7th ed. (2010), p. 1151, which is tion at not to exceed the quantity of incorporated by reference. The Direc- hydrogen peroxide equivalent nec- tor of the Office of the Federal Register essary for the artificial maturing ef- approves this incorporation by ref- fect. erence in accordance with 5 U.S.C. (d) To insure safe use of the additive, 552(a) and 1 CFR part 51. You may ob- the label of the food additive container tain copies from the United States and any intermediate premix thereof Pharmacopeial Convention, 12601 shall bear, in addition to the other in- Twinbrook Pkwy., Rockville, MD 20852 formation required by the act: (Internet address http://www.usp.org). (1) The name of the additive, ‘‘ace- Copies may be examined at the Food tone peroxides’’. and Drug Administration’s Main Li- (2) The concentration of the additive brary, 10903 New Hampshire Ave., Bldg. expressed in hydrogen peroxide equiva- 2, Third Floor, Silver Spring, MD 20993, lents per 100 grams. 301–796–2039, or at the National Ar- (3) Adequate use directions to provide chives and Records Administration a final product that complies with the (NARA). For information on the avail- limitations prescribed in paragraph (c) ability of this material at NARA, call of this section. 202–741–6030 or go to: http:// www.archives.gov/federal-register/cfr/ibr- § 172.803 Advantame. locations.html. (a) Advantame is the chemical N-[N- (c) If the food containing the additive [3-(3-hydroxy-4- is represented to be for special dietary methoxyphenyl)propyl]-a-aspartyl]-L- uses, it shall be labeled in compliance phenylalanine 1-methyl ester, with part 105 of this chapter. monohydrate (CAS Reg. No. 714229–20– [53 FR 28382, July 28, 1988, as amended at 57 6). FR 57961, Dec. 8, 1992; 59 FR 61540, 61543, 61545, (b) Advantame meets the following Dec. 1, 1994; 60 FR 21702, May 3, 1995; 63 FR specifications when it is tested accord- 36362, July 6, 1998; 68 FR 75413, Dec. 31, 2003; ing to the methods described or ref- 78 FR 71464, Nov. 29, 2013] erenced in the document entitled ‘‘Specifications and Analytical Meth- § 172.802 Acetone peroxides. ods for Advantame’’ dated April 1, 2009, The food additive acetone peroxides by the Ajinomoto Co. Inc., Sweetener may be safely used in flour, and in Department 15–1, Kyobashi 1-chome, bread and rolls where standards of Chuo-ku, Tokyo 104–8315, Japan. The identity do not preclude its use, in ac- Director of the Office of the Federal cordance with the following prescribed Register approves this incorporation conditions: by reference in accordance with 5 (a) The additive is a mixture of U.S.C. 552(a) and 1 CFR part 51. Copies monomeric and linear dimeric acetone are available from the Office of Food peroxide, with minor proportions of Additive Safety (HFS–200), Center for higher polymers, manufactured by re- Food Safety and Applied Nutrition, action of hydrogen peroxide and ace- 5001 Campus Dr., College Park, MD tone. 20740. Copies may be examined at the (b) The additive may be mixed with Food and Drug Administration’s Main an edible carrier to give a concentra- Library, 10903 New Hampshire Ave., tion of: (1) 3 grams to 10 grams of hy- Bldg. 2, Third Floor, Silver Spring, MD

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20993, 301–796–2039, or at the National the Office of the Federal Register ap- Archives and Records Administration proves this incorporation by reference (NARA). For information on the avail- in accordance with 5 U.S.C. 552(a) and 1 ability of this material at NARA, call CFR part 51. You may obtain copies 202–741–6030 or go to: http:// from the United States Pharmacopeial www.archives.gov/federal-register/cfr/ibr- Convention, 12601 Twinbrook Pkwy., locations.html. Rockville, MD 20852 (Internet address (1) Assay for advantame, not less http://www.usp.org). Copies may be ex- than 97.0 percent and not more than amined at the Food and Drug Adminis- 102.0 percent on a dry basis. tration’s Main Library, 10903 New (2) Free N-[N-[3-(3-hydroxy-4- Hampshire Ave., Bldg. 2, Third Floor, methoxyphenyl)propyl]-a-aspartyl]-L- Silver Spring, MD 20993, 301–796–2039, or phenylalanine, not more than 1.0 per- at the National Archives and Records cent. Administration (NARA). For informa- (3) Total other related substances, tion on the availability of this mate- not more than 1.5 percent. rial at NARA, call 202–741–6030 or go to: (4) Lead, not more than 1.0 milligram per kilogram. http://www.archives.gov/federal-register/ (5) Water, not more than 5.0 percent. cfr/ibr-locations.html. (6) Residue on ignition, not more (c)(1) When aspartame is used as a than 0.2 percent. sugar substitute tablet for sweetening (7) Specific rotation, determined at20 hot beverages, including coffee and tea, °C [a]D: ¥45.0 to ¥38.0° calculated on a L-leucine may be used as a lubricant in dry basis. the manufacture of such tablets at a (c) The food additive advantame may level not to exceed 3.5 percent of the be safely used as a sweetening agent weight of the tablet. and flavor enhancer in foods generally, (2) When aspartame is used in baked except in meat and poultry, in accord- goods and baking mixes, the amount of ance with current good manufacturing the additive is not to exceed 0.5 percent practice, in an amount not to exceed by weight of ready-to-bake products or that reasonably required to achieve the of finished formulations prior to bak- intended technical effect, in foods for ing. Generally recognized as safe which standards of identity established (GRAS) ingredients or food additives under section 401 of the Federal Food, approved for use in baked goods shall Drug, and Cosmetic Act do not pre- be used in combination with aspartame clude such use. to ensure its functionality as a sweet- (d) If the food containing the additive ener in the final baked product. The purports to be or is represented to be level of aspartame used in these prod- for special dietary use, it must be la- ucts is determined by an analytical beled in compliance with part 105 of method entitled ‘‘Analytical Method this chapter. for the Determination of Aspartame [79 FR 29085, May 21, 2014] and Diketopiperazine in Baked Goods and Baking Mixes,’’ October 8, 1992, § 172.804 Aspartame. which was developed by the Nutrasweet The food additive aspartame may be Co. Copies are available from the Office safely used in food in accordance with of Premarket Approval (HFS–200), Food good manufacturing practice as a and Drug Administration’s Main Li- sweetening agent and a flavor enhancer brary, 10903 New Hampshire Ave., Bldg. in foods for which standards of identity 2, Third Floor, Silver Spring, MD 20993, established under section 401 of the act 301–796–2039, or are available for inspec- do not preclude such use under the fol- tion at the Center for Food Safety and lowing conditions: Applied Nutrition’s Library, Food and (a) Aspartame is the chemical 1- Drug Administration, 5001 Campus Dr., methyl N-L-a-aspartyl-L-phenylalanine College Park, MD 20740, and at the Na- (C14H18N2O5). tional Archives and Records Adminis- (b) The additive meets the specifica- tration (NARA). For information on tions of the Food Chemicals Codex, 7th the availability of this material at ed. (2010), pp. 73–74, which is incor- NARA, call 202–741–6030, or go to: http:// porated by reference. The Director of www.archives.gov/federallregister/

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codeloflfederallregulations/ 0.0045 percent (45 parts per million) by ibrllocations.html. weight of the flour used, including any (d) To assure safe use of the additive, quantity of azodicarbonamide added to in addition to the other information re- flour in accordance with paragraph quired by the Act: (a)(1) of this section. (1) The principal display panel of any (b) To assure safe use of the additive: intermediate mix of the additive for (1) The label and labeling of the addi- manufacturing purposes shall bear a tive and any intermediate premix pre- statement of the concentration of the pared therefrom shall bear, in addition additive contained therein; to the other information required by (2) The label of any food containing the Act, the following: the additive shall bear, either on the (i) The name of the additive. principal display panel or on the infor- (ii) A statement of the concentration mation panel, the following statement: or the strength of the additive in any intermediate premixes. PHENYLKETONURICS: CONTAINS (2) The label or labeling of the food PHENYLALANINE additive shall also bear adequate direc- The statement shall appear in the lations for use. beling prominently and conspicuously as compared to other words, state- § 172.808 Copolymer condensates of ments, designs or devices and in bold ethylene oxide and propylene oxide. type and on clear contrasting back- Copolymer condensates of ethylene ground in order to render it likely to oxide and propylene oxide may be safe- be read and understood by the ordinary ly used in food under the following pre- individual under customary conditions scribed conditions: of purchase and use. (a) The additive consists of one of the (3) When the additive is used in a following: sugar substitute for table use, its label (1) a-Hydro-omega-hydroxy-poly (oxy- shall bear instructions not to use in ethylene) poly(oxypropylene)-(55–61 cooking or baking. moles)poly(oxyethylene) block copoly- (4) Packages of the dry, free-flowing mer, having a molecular weight range additive shall prominently display the of 9,760–13,200 and a cloud point above sweetening equivalence in teaspoons of 100 °C in 1 percent aqueous solution. sugar. (2) a-Hydro-omega-hydroxy-poly (oxy- (e) If the food containing the additive ethylene)poly(oxypropylene)-(53–59 purports to be or is represented for spe- moles)poly(oxyethylene)(14–16 moles) cial dietary uses, it shall be labeled in block copolymer, having a molecular compliance with part 105 of this chap- weight range of 3,500–4,125 and a cloud ter. point of 9 °C–12 °C in 10 percent aqueous [39 FR 27319, July 26, 1974] solution. (3) a-Hydro-omega-hydroxy-poly(ox- EDITORIAL NOTE: For FEDERAL REGISTER ci- yethylene)/poly(oxypropylene) (min- tations affecting § 172.804, see the List of CFR Sections Affected, which appears in the imum 15 moles)/poly(oxyethylene) Finding Aids section of the printed volume block copolymer, having a minimum and at www.govinfo.gov. average molecular weight of 1900 and a minimum cloud point of 9 °C–12 °C in 10 § 172.806 Azodicarbonamide. percent aqueous solution. The food additive azodicarbonamide (4) a-Hydro-omega-hydroxy-poly(ox- may be safely used in food in accord- yethylene) poly (oxypropylene)-(51–57 ance with the following prescribed con- moles) poly(oxyethylene) block copoly- ditions: mer, having an average molecular (a) It is used or intended for use: weight of 14,000 and a cloud point above (1) As an aging and bleaching ingre- 100 °C in 1 percent aqueous solution. dient in cereal flour in an amount not (b) The additive is used or intended to exceed 2.05 grams per 100 pounds of for use as follows: flour (0.0045 percent; 45 parts per mil- (1) The additive identified in para- lion). graph (a)(1) of this section is used in (2) As a dough conditioner in bread practice as a solubilizing and stabi- baking in a total amount not to exceed lizing agent in flavor concentrates

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(containing authorized flavoring oils) Office of Food Additive Safety (HFS– for use in foods for which standards of 200), Food and Drug Administration’s identity established under section 401 Main Library, 10903 New Hampshire of the Act do not preclude such use, Ave., Bldg. 2, Third Floor, Silver provided that the weight of the addi- Spring, MD 20993, 301–796–2039, 240–402– tive does not exceed the weight of the 1200, or may be examined at the Center flavoring oils in the flavor concentrate. for Food Safety and Applied Nutri- (2) The additive identified in para- tion’s Library, Food and Drug Admin- graph (a)(2) of this section is used as a istration, 5001 Campus Dr., College processing aid and wetting agent in Park, MD 20740, or at the National Ar- combination with dioctyl sodium sulfo- chives and Records Administration succinate for fumaric acid as pre- (NARA). For information on the avail- scribed in § 172.810. ability of this material at NARA, call (3) The additive identified in para- 202–741–6030, or go to: http:// graph (a)(3) of this section is used: www.archives.gov/federallregister/ (i) As a surfactant and defoaming codeloflfederallregulations/ agent, at levels not to exceed 0.05 per- ibrllocations.html. cent by weight, in scald baths for poul- (1) Positive for curdlan. try defeathering, followed by potable (2) Assay for curdlan (calculated as water rinse. The temperatures of the anhydrous glucose), not less than 80 scald baths shall be not less than 125 percent. °F. (3) pH of 1 percent aqueous suspen- (ii) As a foam control and rinse adju- sion, 6.0–7.5. vant in hog dehairing machines at a (4) Lead, not more than 0.5 mg/kg. use level of not more than 5 grams per (5) Heavy metals (as Pb), not more hog. than 0.002 percent. (4) The additive identified in para- (6) Total nitrogen, not more than 0.2 graph (a)(4) of this section is used as a percent. dough conditioner in yeast-leavened (7) Loss on drying, not more than 10 bakery products for which standards of percent. identity established under section 401 (8) Residue on ignition, not more of the Act do not preclude such use, than 6 percent. provided that the amount of the addi- (9) Gel strength of 2 percent aqueous tive dose not exceed 0.5 percent by suspension, not less than 600 × 103 dyne weight of the flour used. per square centimeter. [42 FR 14491, Mar. 15, 1977, as amended at 46 (10) Aerobic plate count, not more FR 57476, Nov. 24, 1981] than 103 per gram. (11) Coliform bacteria, not more than § 172.809 Curdlan. 3 per gram. Curdlan may be safely used in ac- (c) Curdlan is used or intended for cordance with the following conditions: use in accordance with good manufac- (a) Curdlan is a high molecular turing practice as a formulation aid, weight polymer of glucose (b-1,3- processing aid, stabilizer and thick- glucan; CAS Reg. No. 54724–00–4) pro- ener, and texturizer in foods for which duced by pure culture fermentation standards of identity established under from the nonpathogenic and section 401 of the act do not preclude nontoxicogenic bacterium Alcaligenes such use. faecalis var. myxogenes. [61 FR 65941, Dec. 16, 1996, as amended at 78 (b) Curdlan meets the following spec- FR 14665, Mar. 7, 2013; 81 FR 5591, Feb. 3, 2016] ifications when it is tested according to the methods described or referenced § 172.810 Dioctyl sodium sulfo- in the document entitled ‘‘Analytical succinate. Methods for Specification Tests for The food additive, dioctyl sodium Curdlan,’’ by Takeda Chemical Indus- sulfosuccinate, meets the specifica- tries, Ltd., 12–10 Nihonbashi, 2–Chome, tions of the Food Chemicals Codex, 7th Chuo-ku, Tokyo, 103, Japan, 1996, which ed. (2010), pp. 313–314, which is incor- is incorporated by reference in accord- porated by reference. The Director of ance with 5 U.S.C. 552(a) and 1 CFR the Office of the Federal Register ap- part 51. Copies are available from the proves this incorporation by reference

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in accordance with 5 U.S.C. 552(a) and 1 provisions of § 163.117 of this chapter CFR part 51. You may obtain copies and the use limitations prescribed in from the United States Pharmacopeial § 172.520, in an amount not to exceed 0.4 Convention, 12601 Twinbrook Pkwy., percent by weight thereof. Rockville, MD 20852 (Internet address (f) As a processing aid and wetting http://www.usp.org). Copies may be ex- agent in combination with a-hydro- amined at the Food and Drug Adminis- omega -hydroxy - poly(oxyethylene) - tration’s Main Library, 10903 New poly-(oxypropylene) (53–59 moles) Hampshire Ave., Bldg. 2, Third Floor, poly(oxyethylene) (14–16 moles) block Silver Spring, MD 20993, 301–796–2039, or copolymer, having a molecular weight at the National Archives and Records range of 3,500–4,125 and a cloud point of Administration (NARA). For informa- 9 °C–12 °C in 10 percent aqueous solution on the availability of this mate- tion, for fumaric acid used in fumaric rial at NARA, call 202–741–6030 or go to: acid-acidulated dry beverage base and http://www.archives.gov/federal-register/ in fumaric acid-acidulated fruit juice cfr/ibr-locations.html). The food additive, drinks, when standards of identity do dioctyl sodium sulfosuccinate, may be not preclude such use. The labeling of safely used in food in accordance with the dry beverage base shall bear ade- the following prescribed conditions: quate directions for use, and the addi- (a) As a wetting agent in the fol- tives shall be used in such an amount lowing fumaric acid-acidulated foods: that the finished beverage or fruit juice Dry gelatin dessert, dry beverage base, drink will contain not in excess of a and fruit juice drinks, when standards total of 10 parts per million of the of identity do not preclude such use. dioctyl sodium sulfosuccinate-block The labeling of the dry gelatin dessert copolymer combination. and dry beverage base shall bear ade- [42 FR 14491, Mar. 15, 1977, as amended at 49 quate directions for use, and the addi- FR 10105, Mar. 19, 1984; 78 FR 71464, Nov. 29, tive shall be used in such an amount 2013] that the finished gelatin dessert will contain not in excess of 15 parts per § 172.811 Glyceryl tristearate. million of the additive and the finished The food additive glyceryl tristearate beverage or fruit juice drink will con- may be safely used in food in accord- tain not in excess of 10 parts per mil- ance with the following prescribed con- lion of the additive. ditions: (b) As a processing aid in sugar fac- (a) The food additive (CAS Reg. No. tories in the production of unrefined 555–43–1) is prepared by reacting stearic cane sugar, in an amount not in excess acid with glycerol in the presence of a of 0.5 part per million of the additive suitable catalyst. per percentage point of sucrose in the (b) The food additive meets the fol- juice, syrup, or massecuite being proc- lowing specifications: essed, and so used that the final molasses will contain no more than 25 parts Acid number: Not to exceed 1.0. per million of the additive. Iodine number: Not to exceed 1.0. (c) As a solubilizing agent on gums Saponification number: 186–192. and hydrophilic colloids to be used in Hydroxyl number: Not to exceed 5.0. food as stabilizing and thickening Free glycerol content: Not to exceed 0.5 percent. agents, when standards of identity do Unsaponifiable matter: Not to exceed 0.5 per- not preclude such use. The additive is cent. used in an amount not to exceed 0.5 Melting point (Class II): 69 °C–73 °C. percent by weight of the gums or hydrophilic colloids. (c) The additive is used or intended (d) As an emulsifying agent for cocoa for use as follows when standards of fat in noncarbonated beverages con- identity established under section 401 taining cocoa, whereby the amount of of the Act do not preclude such use: the additive does not exceed 25 parts Uses Limitations per million of the finished beverage. (e) As a dispersing agent in ‘‘cocoa 1. As a crystallization accel- Not to exceed 1 percent of erator in cocoa products, in the combined weight of with dioctyl sodium sulfosuccinate for imitation chocolate, and in the formulation. manufacturing’’ that conforms to the compound coatings.

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Uses Limitations (b) The additive is used or intended for use as follows: 2. As a formulation aid as de- Not to exceed 0.5 percent. fined in § 170.3(o)(14) of this Uses Limitations chapter, lubricant and release agent as defined in As a masking agent for the Not to exceed 0.2 percent in § 170.3(o)(18) of this chapter, bitter aftertaste of sac- the finished beverage. and surface-finishing agent as charin used in manufac- defined in § 170.3(o)(30) of tured beverages and bev- this chapter in food. erage bases. 3. As a formulation aid as de- Not to exceed 3.0 percent As a stabilizer in mono- and Not to exceed 0.02 percent of fined in § 170.3(o)(14) of this of the combined weight diglycerides prepared by the mono- and chapter in confections. of the formulation. the glycerolysis of edible diglycerides. 4. As a formulation aid as de- Not to exceed 1.0 percent fats or oils. fined in § 170.3(o)(14) of this of the combined weight chapter in fats and oils as de- of the formulation. fined in § 170.3 (n)(12) of this (c) To assure safe use of the additive, chapter. in addition to the other information re- 5. As a winterization and frac- Not to exceed 0.5 percent quired by the Act: tionation aid in fat and oil by weight of the proc- processing. essed fat or oil. (1) The labeling of the additive shall bear adequate directions for use of the (d) To assure safe use of the additive: additive in compliance with the provi- (1) In addition to the other informa- sions of this section. tion required by the act, the label or (2) The labeling of beverage bases labeling of the additive shall bear the containing the additive shall bear ade- name of the additive. quate directions for use to provide that (2) The label of the additive shall beverages prepared therefrom shall bear adequate directions to provide a contain no more than 0.2 percent gly- final product that complies with the cine. limitations prescribed in paragraph (c) [42 FR 14491, Mar. 15, 1977, as amended at 49 of this section. FR 10105, Mar. 19, 1984; 78 FR 71464, Nov. 29, 2013] [53 FR 21632, June 9, 1988, as amended at 59 FR 24924, May 13, 1994] § 172.814 Hydroxylated lecithin. § 172.812 Glycine. The food additive hydroxylated The food additive glycine may be lecithin may be safely used as an emul- safely used for technological purposes sifier in foods in accordance with the in food in accordance with the fol- following conditions: lowing prescribed conditions: (a) The additive is obtained by the (a) The additive meets the specifica- treatment of lecithin in one of the following ways, under controlled conditions of the Food Chemicals Codex, 7th tions whereby the separated fatty acid ed. (2010), pp. 457–458, which is incor- fraction of the resultant product has porated by reference. The Director of an acetyl value of 30 to 38: the Office of the Federal Register approves this incorporation by reference (1) With hydrogen peroxide, benzoyl in accordance with 5 U.S.C. 552(a) and 1 peroxide, lactic acid, and sodium hy- CFR part 51. You may obtain copies droxide. from the United States Pharmacopeial (2) With hydrogen peroxide, acetic Convention, 12601 Twinbrook Pkwy., acid, and sodium hydroxide. Rockville, MD 20852 (Internet address (b) It is used or intended for use, in http://www.usp.org). Copies may be ex- accordance with good manufacturing amined at the Food and Drug Adminis- practice, as an emulsifier in foods, ex- tration’s Main Library, 10903 New cept for those standardized foods that Hampshire Ave., Bldg. 2, Third Floor, do not provide for such use. Silver Spring, MD 20993, 301–796–2039, or (c) To assure safe use of the additive, at the National Archives and Records the label of the food additive container Administration (NARA). For informa- shall bear, in addition to the other in- tion on the availability of this mate- formation required by the Act: rial at NARA, call 202–741–6030 or go to: (1) The name of the additive, http://www.archives.gov/federal-register/ ‘‘hydroxylated lecithin’’. cfr/ibr-locations.html. (2) Adequate directions for its use.

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§ 172.816 Methyl glucoside-coconut oil the limitations prescribed in paragraph ester. (b) of this section. Methyl glucoside-coconut oil ester § 172.820 Polyethylene glycol (mean may be safely used in food in accord- molecular weight 200-9,500). ance with the following conditions: (a) It is the methyl glucoside-coconut Polyethylene glycol identified in this oil ester having the following specifica- section may be safely used in food in tions: accordance with the following prescribed conditions: Acid number: 10–20 (a) Identity. (1) The additive is an ad- Hydroxyl number: 200–300 dition polymer of ethylene oxide and pH (5% aqueous): 4.8–5.0 water with a mean molecular weight of Saponification number: 178–190 200 to 9,500. (b) It is used or intended for use as (2) It contains no more than 0.2 per- follows: cent total by weight of ethylene and (1) As an aid in crystallization of su- diethylene glycols when tested by the crose and dextrose at a level not to ex- analytical methods prescribed in para- ceed the minimum quantity required to graph (b) of this section. produce its intended effect. (b) Analytical method. (1) The analyt- (2) As a surfactant in molasses at a ical method prescribed in the National level not to exceed 320 parts per million Formulary XV (1980), page 1244, for pol- in the molasses. yethylene glycol 400 shall be used to determine the total ethylene and § 172.818 Oxystearin. diethylene glycol content of poly- The food additive oxystearin may be ethylene glycols having mean molec- safely used in foods, when such use is ular weights of 450 or higher. not precluded by standards of identity (2) The following analytical method in accordance with the following condi- shall be used to determine the total tions: ethylene and diethylene glycol content (a) The additive is a mixture of the of polyethylene glycols having mean glycerides of partially oxidized stearic molecular weights below 450. and other fatty acids obtained by heating hydrogenated cottonseed or soy- ANALYTICAL METHOD bean oil under controlled conditions, in the presence of air and a suitable cata- ETHYLENE GLYCOL AND DIETHYLENE GLYCOL CONTENT OF POLYETHYLENE GLYCOLS lyst which is not a food additive as so defined. The resultant product meets The analytical method for determining the following specifications: ethylene glycol and diethylene glycol is as follows: Acid number: Maximum 15. Iodine number: Maximum 15. APPARATUS Saponification number: 225–240. Gas chromatograph with hydrogen flame Hydroxyl number: 30–45. ionization detector (Varian Aerograph 600 D Unsaponifiable material: Maximum 0.8 per- or equivalent). The following conditions cent. shall be employed with the Varian ± ° Refractive index (butyro): 60 1 at 48 C. Aerograph 600 D gas chromatograph: (b) It is used or intended for use as a Column temperature: 165 °C. ° crystallization inhibitor in vegetable Inlet temperature: 260 C. Carrier gas (nitrogen) flow rate: 70 milli- oils and as a release agent in vegetable liters per minute. oils and vegetable shortenings, where- Hydrogen and air flow to burner: Optimize by the additive does not exceed 0.125 to give maximum sensitivity. percent of the combined weight of the Sample size: 2 microliters. oil or shortening. Elution time: Ethylene glycol: 2.0 minutes. (c) To insure safe use of the additive, Diethylene glycol: 6.5 minutes. the label and labeling of the additive Recorder: ¥0.5 to + 1.05 millivolt, full span, container shall bear, in addition to the 1 second full response time. Syringe: 10-microliter (Hamilton 710 N or other information required by the Act: equivalent). (1) The name of the additive. Chromatograph column: 5 feet × 1⁄8 inch. (2) Adequate directions to provide an I.D. stainless steel tube packed with sorbitol oil or shortening that complies with (Mathieson-Coleman-Bell 2768 Sorbitol

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SX850, or equivalent) 12 percent in H2O by (3) As an adjuvant in dispersing vita- weight on 60–80 mesh nonacid washed diato- min and/or mineral preparations. maceous earth (Chromosorb W. Johns-Man- (4) As a coating on sodium nitrite to ville, or equivalent). inhibit hygroscopic properties. REAGENTS AND MATERIALS (d) Limitations. (1) It is used in an amount not greater than that required Carrier gas, nitrogen: Commercial grade in cylinder equipped with reducing regulator to to produce the intended physical or provide 50 p.s.i.g. to the gas chromatograph. technical effect. Ethylene glycol: Commercial grade. Purify (2) A tolerance of zero is established if necessary, by distillation. for residues of polyethylene glycol in Diethylene glycol: Commercial grade. Pu- milk. rify, if necessary, by distillation. Glycol standards: Prepare [42 FR 14491, Mar. 15, 1977, as amended at 49 chromatographic standards by dissolving FR 10105, Mar. 19, 1984] known amounts of ethylene glycol and diethylene glycol in water. Suitable con- § 172.822 Sodium lauryl sulfate. centrations for standardization range from 1 The food additive sodium lauryl sul- to 6 milligrams of each component per milli- fate may be safely used in food in ac- liter (for example 10 milligrams diluted to cordance with the following conditions: volume in a 10-milliliter volumetric flask is equivalent to 1 milligram per milliliter). (a) The additive meets the following specifications: STANDARDIZATION (1) It is a mixture of sodium alkyl Inject a 2-microliter aliquot of the glycol sulfates consisting chiefly of sodium standard into the gas chromatograph em- lauryl sulfate [CH2(CH2)10CH2OSO2Na]. ploying the conditions described above. (2) It has a minimum content of 90 Measure the net peak heights for the ethyl- percent sodium alkyl sulfates. ene glycol and for the diethylene glycol. (b) It is used or intended for use: Record the values as follows: (1) As an emulsifier in or with egg A = Peak height in millimeters of the whites whereby the additive does not ethylene glycol peak. B = milligrams of ethylene glycol per mil- exceed the following limits: liliter of standard solution. Egg white solids, 1,000 parts per million. C = Peak height in millimeters of the Frozen egg whites, 125 parts per million. diethylene glycol peak. Liquid egg whites, 125 parts per million. D = Milligrams of diethylene glycol per milliliter of standard solution. (2) As a whipping agent at a level not to exceed 0.5 percent by weight of gela- PROCEDURE tine used in the preparation of marsh- Weigh approximately 4 grams of poly- mallows. ethylene glycol sample accurately into a 10- (3) As a surfactant in: milliliter volumetric flask. Dilute to volume (i) Fumaric acid-acidulated dry bev- with water. Mix the solution thoroughly and erage base whereby the additive does inject a 2-microliter aliquot into the gas not exceed 25 parts per million of the chromatograph. Measure the heights, in millimeters, of the ethylene glycol peak and of finished beverage and such beverage the diethylene glycol peak and record as E base is not for use in a food for which and F, respectively. a standard of identity established under section 401 of the Act precludes Percent ethylene glycol = (E × B) / (A × sample weight in grams) such use. (ii) Fumaric acid-acidulated fruit Percent diethylene glycol = (F × D) / (C × juice drinks whereby the additive does sample weight in grams) not exceed 25 parts per million of the (c) Uses. It may be used, except in finished fruit juice drink and it is not milk or preparations intended for addi- used in a fruit juice drink for which a tion to milk, as follows: standard of identity established under (1) As a coating, binder, plasticizing section 401 of the Act precludes such agent, and/or lubricant in tablets used use. for food. (4) As a wetting agent at a level not (2) As an adjuvant to improve flavor to exceed 10 parts per million in the and as a bodying agent in nonnutritive partition of high and low melting frac- sweeteners identified in § 180.37 of this tions of crude vegetable oils and ani- chapter. mal fats, provided that the partition

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step is followed by a conventional re- § 172.826 Sodium stearyl fumarate. fining process that includes alkali neu- Sodium stearyl fumarate may be tralization and deodorization of the safely used in food in accordance with fats and oils. the following conditions: (c) To insure the safe use of the addi- (a) It contains not less than 99 per- tive, the label of the food additive con- cent sodium stearyl fumarate cal- tainer shall bear, in addition to the culated on the anhydrous basis, and other information required by the Act: not more than 0.25 percent sodium ste- (1) The name of the additive, sodium aryl maleate. lauryl sulfate. (b) The additive is used or intended (2) Adequate use directions to provide for use: a final product that complies with the (1) As a dough conditioner in yeast- limitations prescribed in paragraph (b) leavened bakery products in an amount of this section. not to exceed 0.5 percent by weight of [42 FR 14491, Mar. 15, 1977, as amended at 43 the flour used. FR 18668, May 2, 1978] (2) As a conditioning agent in dehydrated potatoes in an amount not to § 172.824 Sodium mono- and dimethyl exceed 1 percent by weight thereof. naphthalene sulfonates. (3) As a stabilizing agent in The food additive sodium mono- and nonyeast-leavened bakery products in dimethyl naphthalene sulfonates may an amount not to exceed 1 percent by be safely used in accordance with the weight of the flour used. following prescribed conditions: (4) As a conditioning agent in proc- (a) The additive has a molecular essed cereals for cooking in an amount weight range of 245–260. not to exceed 1 percent by weight of (b) The additive is used or intended the dry cereal, except for foods for for use: which standards of identity preclude (1) In the crystallization of sodium such use. carbonate in an amount not to exceed (5) As a conditioning agent in starch- 250 parts per million of the sodium car- thickened or flour-thickened foods in bonate. Such sodium carbonate is used an amount not to exceed 0.2 percent by or intended for use in potable water weight of the food. systems to reduce hardness and aid in sedimentation and coagulation by rais- § 172.828 Acetylated monoglycerides. ing the pH for the efficient utilization of other coagulation materials. The food additive acetylated monoglycerides may be safely used in (2) As an anticaking agent in sodium or on food in accordance with the fol- nitrite at a level not in excess of 0.1 percent by weight thereof for author- lowing prescribed conditions: ized uses in cured fish and meat. (a) The additive is manufactured by: (c) In addition to the general labeling (1) The interesterification of edible requirements of the Act: fats with triacetin and in the presence (1) Sodium carbonate produced in ac- of catalytic agents that are not food cordance with paragraph (b)(1) of this additives or are authorized by regula- section shall be labeled to show the tion, followed by a molecular distilla- presence of the additive and its label or tion or by steam stripping; or labeling shall bear adequate directions (2) The direct acetylation of edible for use. monoglycerides with acetic anhydride (2) Sodium nitrite produced in ac- without the use of catalyst or molec- cordance with paragraph (b)(2) of this ular distillation, and with the removal section shall bear the labeling required by vacuum distillation, if necessary, of by § 172.175 and a statement declaring the acetic acid, acetic anhydride, and the presence of sodium mono- and di- triacetin. methyl naphthalene sulfonates. (b) The food additive has a Reichert- Meissl value of 75–200 and an acid value [42 FR 14491, Mar. 15, 1977, as amended at 63 of less than 6. FR 7069, Feb. 12, 1998]

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(c) The food additive is used at a (7) Specific rotation, determined at level not in excess of the amount rea- 20 °C [a]D: ¥40.0° to 43.4° calculated on sonably required to produce its in- a dry basis. tended effect in food, or in food-proc- (c) The food additive neotame may be essing, food-packing, or food-storage safely used as a sweetening agent and equipment. flavor enhancer in foods generally, except in meat and poultry, in accord- [42 FR 14491, Mar. 15, 1977, as amended at 50 ance with current good manufacturing FR 3508, Jan. 25, 1985] practice, in an amount not to exceed § 172.829 Neotame. that reasonably required to accomplish the intended technical effect, in foods (a) Neotame is the chemical N-[N- for which standards of identity estab- (3,3-dimethylbutyl)-L-a-aspartyl]-L- lished under section 401 of the Federal phenylalanine-1-methyl ester (CAS Food, Drug, and Cosmetic Act do not Reg. No. 165450–17–9). preclude such use. (b) Neotame meets the following (d) When neotame is used as a sugar specifications when it is tested accord- substitute tablet, L-leucine may be ing to the methods described or ref- used as a lubricant in the manufacture erenced in the document entitled of tablets at a level not to exceed 3.5 ‘‘Specifications and Analytical Meth- percent of the weight of the tablet. ods for Neotame’’ dated April 3, 2001, (e) If the food containing the additive by the NutraSweet Co., 699 North purports to be or is represented to be Wheeling Rd., Mount Prospect, IL for special dietary use, it shall be la- 60056. The Director of the Office of the beled in compliance with part 105 of Federal Register has approved the in- this chapter. corporation by reference of this material in accordance with 5 U.S.C. 552(a) [67 FR 45310, July 9, 2002, as amended at 81 FR 5591, Feb. 3, 2016] and 1 CFR part 51. Copies are available from the Office of Food Additive Safety § 172.830 Succinylated monoglycerides. (HFS–200), Food and Drug Administra- tion’s Main Library, 10903 New Hamp- The food additive succinylated shire Ave., Bldg. 2, Third Floor, Silver monoglycerides may be safely used in Spring, MD 20993, 301–796–2039. Copies food in accordance with the following may be examined at the Center for prescribed conditions: Food Safety and Applied Nutrition’s (a) The additive is a mixture of semi- Library, 5001 Campus Dr., rm. 1C–100, and neutral succinic acid esters of College Park, MD 20740, or at the Na- mono- and diglycerides produced by the tional Archives and Records Adminis- succinylation of a product obtained by tration (NARA). For information on the glycerolysis of edible fats and oils, the availability of this material at or by the direct esterification of glyc- NARA, call 202–741–6030, or go to: http:// erol with edible fat-forming fatty acids. www.archives.gov/federallregister/ codeloflfederallregulations/ (b) The additive meets the following ibrllocations.html. specifications: (1) Assay for neotame, not less than Succinic acid content: 14.8%–25.6% 97.0 percent and not more than 102.0 Melting point: 50 °C–60 °C. percent on a dry basis. Acid number: 70–120 (2) Free dipeptide acid (N-[N-(3,3- (c) The additive is used or intended dimethylbutyl)-L-a-aspartyl]-L- for use in the following foods: phenylalanine), not more than 1.5 per- (1) As an emulsifier in liquid and cent. plastic shortenings at a level not to ex- (3) Other related substances, not ceed 3 percent by weight of the short- more than 2.0 percent. ening. (4) Lead, not more than 2.0 milli- (2) As a dough conditioner in bread grams per kilogram. baking, when such use is permitted by (5) Water, not more than 5.0 percent. an appropriate food standard, at a level (6) Residue on ignition, not more not to exceed 0.5 percent by weight of than 0.2 percent the flour used.

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§ 172.831 Sucralose. (b) It is used, or intended for use, in (a) Sucralose is the chemical 1,6- antioxidant formulations for addition to oils and fats whereby the additive dichloro-1,6-dideoxy-b-D- does not exceed 200 parts per million of fructofuranosyl-4-chloro-4-deoxy-a-D- galactopyranoside (CAS Reg. No. 56038– the combined weight of the oil or fat 13–2). and the additive. (b) The additive meets the specifica- (c) To assure safe use of the additive: tions of the Food Chemicals Codex, 7th (1) The container label shall bear, in ed. (2010), pp. 993–995, which is incor- addition to the other information re- porated by reference. The Director of quired by the Act, the name of the ad- the Office of the Federal Register ap- ditive. proves this incorporation by reference (2) The label or accompanying label- in accordance with 5 U.S.C. 552(a) and 1 ing shall bear adequate directions for CFR part 51. You may obtain copies the use of the additive which, if fol- from the United States Pharmacopeial lowed, will result in a food that com- Convention, 12601 Twinbrook Pkwy., plies with the requirements of this sec- Rockville, MD 20852 (Internet address tion. http://www.usp.org). Copies may be examined at the Food and Drug Adminis- § 172.833 Sucrose acetate isobutyrate tration’s Main Library, 10903 New (SAIB). Hampshire Ave., Bldg. 2, Third Floor, Sucrose acetate isobutyrate may be Silver Spring, MD 20993, 301–796–2039, or safely used in foods in accordance with at the National Archives and Records the following prescribed conditions: Administration (NARA). For informa- (a) Sucrose acetate isobutyrate (CAS tion on the availability of this mate- Reg. No. 27216–37–1), or SAIB, is the rial at NARA, call 202–741–6030 or go to: chemical alpha-D-glucopyranoside, O- http://www.archives.gov/federal-register/ acetyl-tris-O-(2-methyl-1-oxopropyl)- cfr/ibr-locations.html. beta-D-fructofuranosyl, acetate tris(2- (c) The additive may be used as a methyl propanoate). sweetener in foods generally, in accordance with current good manufacturing (b) SAIB, a pale, straw-colored liquid, practice in an amount not to exceed meets the following specifications: (1) that reasonably required to accomplish Assay: Not less than 98.8 percent and the intended effect. not more than 101.9 percent, based on (d) If the food containing the additive the following formula: purports to be or is represented to be Assay = ((SV 0.10586) ÷ 56.1) × 100 for special dietary use, it shall be labeled in compliance with part 105 of Where SV = Saponification value this chapter. (2) Saponification value: 524–540 de- [63 FR 16433, Apr. 3, 1998, as amended at 64 termined using 1 gram of sample by the FR 43909, Aug. 12, 1999; 78 FR 14665, Mar. 7, ‘‘Guide to Specifications for General 2013; 78 FR 71464, Nov. 29, 2013] Notices, General Analytical Tech- niques, Identification Tests, Test Solu- § 172.832 Monoglyceride citrate. tions, and Other Reference Materials,’’ A food additive that is a mixture of in the ‘‘Compendium of Food Additive glyceryl monooleate and its citric acid Specifications, Addendum 4, Food and monoester manufactured by the reac- Agriculture Organization of the United tion of glyceryl monooleate with citric Nations (FAO), Food and Nutrition acid under controlled conditions may Paper 5, Revision 2’’ (1991), pp. 203 and be safely used as a synergist and solu- 204, which is incorporated by reference, bilizer for antioxidants in oils and fats, in accordance with 5 U.S.C. 552(a) and 1 when used in accordance with the con- CFR part 51. Copies are available from ditions prescribed in this section. the Office of Food Additive Safety (a) The food additive meets the fol- (HFS–200), Food and Drug Administra- lowing specifications: tion’s Main Library, 10903 New Hamp- Acid number, 70–100. shire Ave., Bldg. 2, Third Floor, Silver Total citric acid (free and combined), 14 per- Spring, MD 20993, 301–796–2039, 240–402– cent–17 percent. 1200, or may be examined at the Center

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for Food Safety and Applied Nutri- erence; see paragraph (b)(2) of this section’s Library, 5001 Campus Dr., Col- tion for availability of the incorpora- lege Park, MD 20740, or at the National tion by reference. Archives and Records Administration (c) The food additive is used as a sta- (NARA). For information on the avail- bilizer (as defined in § 170.3(o)(28) of this ability of this material at NARA, call chapter) of emulsions of flavoring oils 202–741–6030, or go to: http:// in nonalcoholic beverages. www.archives.gov/federallregister/ (d) The total SAIB content of a bev- codeloflfederallregulations/ erage containing the additive does not ibrllocations.html. exceed 300 milligrams/kilogram of the (3) Acid value: Not to exceed 0.20 de- finished beverage. termined using 50 grams of sample by [64 FR 29958, June 4, 1999; 64 FR 43072, Aug. 9, the ‘‘Guide to Specifications for Gen- 1999, as amended at 78 FR 14665, Mar. 7, 2013; eral Notices, General Analytical Tech- 81 FR 5591, Feb. 3, 2016] niques, Identification Tests, Test Solu- tions, and Other Reference Materials,’’ § 172.834 Ethoxylated mono- and in the ‘‘Compendium of Food Additive diglycerides. Specifications, Addendum 4, FAO Food The food additive ethoxylated mono- and Nutrition Paper 5, Revision 2,’’ p. and diglycerides (polyoxyethylene (20) 189 (1991), which is incorporated by ref- mono- and diglycerides of fatty acids) erence; see paragraph (b)(2) of this sec- (polyglycerate 60) may be safely used tion for availability of the incorpora- in food in accordance with the fol- tion by reference. lowing prescribed conditions: (4) Lead: Not to exceed 1.0 milli- (a) The food additive is manufactured grams/kilogram determined by the by: ‘‘Atomic Absorption (1) Glycerolysis of edible fats pri- Spectrophotometric Graphite Furnace marily composed of stearic, palmitic, Method, Method I,’’ in the ‘‘Food and myristic acids; or Chemicals Codex,’’ 4th ed. (1996), pp. 763 (2) Direct esterification of glycerol and 764, with an attached modification with a mixture of primarily stearic, to the sample digestion section in Ap- palmitic, and myristic acids; pendix III.B (July 1996), which is incorporated by reference. Copies are avail- to yield a product with less than 0.3 able from the National Academy Press, acid number and less than 0.2 percent 2101 Constitution Ave. NW., Box 285, water, which is then reacted with Washington, DC 20055 (Internet http:// ethylene oxide. www.nap.edu), or may be examined at (b) The additive meets the following the Food and Drug Administration’s specifications: Main Library, 10903 New Hampshire Saponification number, 65–75. Ave., Bldg. 2, Third Floor, Silver Acid number, 0–2. Spring, MD 20993, 301–796–2039, or at the Hydroxyl number, 65–80. National Archives and Records Admin- Oxyethylene content, 60.5–65.0 percent. istration (NARA). For information on (c) The additive is used or intended the availability of this material at for use in the following foods when NARA, call 202–741–6030, or go to: http:// standards of identity established under www.archives.gov/federallregister/ section 401 of the Act do not preclude codeloflfederallregulations/ such use: ibrllocations.html. (5) Triacetin: Not to exceed 0.10 per- Use Limitations cent determined by gas chroma- 1. As an emulsifier in pan-re- Not to exceed levels required tography as described in the ‘‘Guide to lease agents for and as a to produce the intended ef- Specifications for General Notices, dough conditioner in yeast- fects, total not to exceed General Analytical Techniques, Identi- leavened bakery products. 0.5 percent by weight of the flour used. fication Tests, Test Solutions, and 2. As an emulsifier in cakes Not to exceed 0.5 percent by Other Reference Materials,’’ in the and cake mixes. weight of the dry ingredi- ‘‘Compendium of Food Additive Speci- ents. fications, Addendum 4, FAO Food and 3. As an emulsifier in Not to exceed 0.45 percent whipped vegetable oil top- by weight of the finished Nutrition Paper 5, Revision 2,’’ (1991), pings and topping mixes. whipped vegetable oil top- pp. 13–26, which is incorporated by ref- pings.

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Use Limitations with sorbitan monostearate may be used in excess of 0.4 percent, provided 4. As an emulsifier in icings Not to exceed 0.5 percent by and icing mixes. weight of the finished that the amount of the additive does icings. not exceed 0.77 percent and the amount 5. As an emulsifier in frozen Not to exceed 0.2 percent by of sorbitan monostearate does not ex- desserts. weight of the finished fro- ceed 0.27 percent of the weight of the zen desserts. 6. As an emulsifier in edible Not to exceed 0.4 percent by finished whipped edible oil topping. vegetable fat-water emul- weight of the finished vege- (2) As an emulsifier in cakes and cake sions intended for use as table fat-water emulsions. mixes, with or without one or a com- substitutes for milk or cream in beverage coffee. bination of the following: (i) Polysorbate 65. (d) When the name ‘‘polyglycerate (ii) Sorbitan monostearate. 60’’ is used in labeling it shall be fol- When used alone, the maximum lowed by either ‘‘polyoxyethylene (20) amount of polysorbate 60 shall not ex- mono-and diglycerides of fatty acids’’ ceed 0.46 percent of the cake or cake or ‘‘ethoxylated mono- and mix, on a dry-weight basis. When used diglycerides’’ in parentheses. with polysorbate 65 and/or sorbitan [42 FR 14491, Mar. 15, 1977, as amended at 42 monostearate, it shall not exceed 0.46 FR 37973, July 26, 1977; 50 FR 49536, Dec. 3, percent, nor shall the polysorbate 65 1985] exceed 0.32 percent or the sorbitan monostearate exceed 0.61 percent, and § 172.836 Polysorbate 60. no combination of these emulsifiers The food additive polysorbate 60 shall exceed 0.66 percent of the cake or (polyoxyethylene (20) sorbitan mono- cake mix, all calculated on a dry- stearate) which is a mixture of weight basis. polyoxyethylene ethers of mixed par- (3) As an emulsifier, alone or in com- tial stearic and palmitic acid esters of bination with sorbitan monostearate, sorbitol anhydrides and related com- in nonstandardized confectionery coat- pounds, may be safely used in food in ings and standardized cacao products accordance with the following pre- specified in §§ 163.123, 163.130, 163.135, scribed conditions: 163.140, 163.145, and 163.150 of this chap- (a) The food additive is manufactured ter, as follows: by reacting stearic acid (usually con- (i) It is used alone in an amount not taining associated fatty acids, chiefly to exceed 0.5 percent of the weight of palmitic) with sorbitol to yield a prod- the finished nonstandardized confec- uct with a maximum acid number of 10 tionery coating or standardized cacao and a maximum water content of 0.2 product. percent, which is then reacted with (ii) It is used with sorbitan mono- ethylene oxide. stearate in any combination of up to (b) The food additive meets the fol- 0.5 percent of polysorbate 60 and up to lowing specifications: 1 percent of sorbitan monostearate: Saponification number 45–55. Provided, That the total combination Acid number 0–2. does not exceed 1 percent of the weight Hydroxyl number 81–96. of the finished nonstandardized confec- Oxyethylene content 65 percent–69.5 percent. tionery coating or standardized cacao (c) It is used or intended for use as product. follows: (4) [Reserved] (1) As an emulsifier in whipped edible (5) As an emulsifier in cake icings oil topping with or without one or a and cake fillings, with or without one combination of the following: or a combination of the following: (i) Sorbitan monostearate; (i) Polysorbate 65. (ii) Polysorbate 65; (ii) Sorbitan monostearate. (iii) Polysorbate 80; When used alone, the maximum whereby the maximum amount of the amount of polysorbate 60 shall not ex- additive or additives used does not exceed 0.46 percent of the weight of the ceed 0.4 percent of the weight of the cake icings and cake fillings. When finished whipped edible oil topping; ex- used with polysorbate 65 and/or sorbi- cept that a combination of the additive tan monostearate, it shall not exceed

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0.46 percent, nor shall the polysorbate not to exceed 0.5 percent by weight of 65 exceed 0.32 percent or the sorbitan the flour used. monostearate exceed 0.7 percent, and (12) As an emulsifier, alone or in no combination of these emulsifiers combination with sorbitan monostea- shall exceed 1 percent of the weight of rate, in the minimum quantity re- the cake icing or cake filling. quired to accomplish the intended ef- (6) To impart greater opacity to fect, in formulations of white mineral sugar-type confection coatings where- oil conforming with § 172.878 and/or pe- by the maximum amount of the addi- troleum wax conforming with § 172.886 tive does not exceed 0.2 percent of the for use as protective coatings on raw weight of the finished sugar coating. fruits and vegetables. (7) As an emulsifier in nonstandard- (13) As a dispersing agent in artifi- ized dressings whereby the maximum cially sweetened gelatin desserts and in amount of the additive does not exceed artificially sweetened gelatin dessert 0.3 percent of the weight of the finished mixes, whereby the amount of the addi- dressings. tive does not exceed 0.5 percent on a (8) As an emulsifier, alone or in com- dry-weight basis. bination with polysorbate 80, in (14) As an emulsifier in chocolate fla- shortenings and edible oils intended for vored syrups, whereby the maximum use in foods as follows, when standards amount of the additive does not exceed of identity established under section 0.05 percent in the finished product. 401 of the act do not preclude such use: (15) As a surfactant and wetting (i) It is used alone in an amount not agent for natural and artificial colors to exceed 1 percent of the weight of the in food as follows: finished shortening or oil. (i) In powdered soft drink mixes in an (ii) It is used with polysorbate 80 in amount not to exceed 4.5 percent by any combination providing no more weight of the mix. than 1 percent of polysorbate 60 and no (ii) In sugar-based gelatin dessert more than 1 percent of polysorbate 80, mixes in an amount not to exceed 0.5 provided that the total combination percent by weight of the mix. does not exceed 1 percent of the fin- (iii) In artificially sweetened gelatin ished shortening or oil. dessert mixes in an amount not to ex- (iii) The 1–percent limitation speci- ceed 3.6 percent by weight of the mix. fied in paragraph (c)(8) (i) and (ii) of (iv) In sugar-based pudding mixes in this section may be exceeded in premix an amount not to exceed 0.5 percent by concentrates of shortening or edible oil weight of the mix. if the labeling complies with the re- (v) In artificially sweetened pudding quirements of paragraph (d) of this sec- mixes in an amount not to exceed 0.5 tion. percent by weight of the mix. (9) As an emulsifier in solid-state, ed- (16) As an emulsifier in ice cream, ible vegetable fat-water emulsions in- frozen custard, fruit sherbet, and non- tended for use as substitutes for milk standardized frozen desserts when used or cream in beverage coffee, with or alone or in combination with poly- without one or a combination of the sorbate 65 and/or polysorbate 80, where- following: by the maximum amount of the addi- (i) Polysorbate 65. tives, alone or in combination, does not (ii) Sorbitan monostearate. exceed 0.1 percent of the finished frozen The maximum amount of the additive dessert. or additives shall not exceed 0.4 per- (d) To assure safe use of the additive, cent by weight of the finished edible in addition to the other information re- vegetable fat-water emulsion. quired by the Act: (10) As a foaming agent in non- (1) The label of the additive and any alcoholic mixes, to be added to alco- intermediate premixes shall bear: holic beverages in the preparation of (i) The name of the additive. mixed alcoholic drinks, at a level not (ii) A statement of the concentration to exceed 4.5 percent by weight of the or strength of the additive in any in- nonalcoholic mix. termediate premixes. (11) As a dough conditioner in yeast- (2) The label or labeling shall bear leavened bakery products in an amount adequate directions to provide a final

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product that complies with the limita- cake mix, all calculated on a dry- tions prescribed in paragraph (c) of this weight basis. section. (3) As an emulsifier in whipped edible oil topping with or without one or a [42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 25, 1978; 45 FR 58836, Sept. 5, combination of the following: 1980; 46 FR 8466, Jan. 27, 1981; 64 FR 57976, (i) Sorbitan monostearate; Oct. 28, 1999] (ii) Polysorbate 60; (iii) Polysorbate 80; § 172.838 Polysorbate 65. whereby the maximum amount of the The food additive polysorbate 65 additive or additives used does not ex- (polyoxyethylene (20) sorbitan ceed 0.4 percent of the weight of the tristearate), which is a mixture of finished whipped edible oil topping. polyoxyethylene ethers of mixed ste- (4) As an emulsifier in solid-state, ed- aric acid esters of sorbitol anhydrides ible vegetable fat-water emulsions in- and related compounds, may be safely tended for use as substitutes for milk used in food in accordance with the fol- or cream in beverage coffee, with or lowing prescribed conditions: without one or a combination of the (a) The food additive is manufactured following: by reacting stearic acid (usually con- (i) Sorbitan monostearate. taining associated fatty acids, chiefly (ii) Polysorbate 60. palmitic) with sorbitol to yield a product with a maximum acid number of 15 The maximum amount of the additive and a maximum water content of 0.2 or additives shall not exceed 0.4 per- percent, which is then reacted with cent by weight of the finished edible ethylene oxide. vegetable fat-water emulsion. (b) The food additive meets the fol- (5) As an emulsifier in cake icings lowing specifications: and cake fillings, with or without one or a combination of the following: Saponification number 88–98. (i) Sorbitan monostearate. Acid number 0–2. (ii) Polysorbate 60. Hydroxyl number 44–60. Oxyethylene content 46 percent–50 percent. When used alone, the maximum amount of polysorbate 65 shall not ex- (c) The additive is used, or intended ceed 0.32 percent of the weight of the for use, as follows: cake icing or cake filling. When used (1) As an emulsifier in ice cream, fro- with sorbitan monostearate and/or zen custard, ice milk, fruit sherbet and polysorbate 60, it shall not exceed 0.32 nonstandardized frozen desserts when percent, nor shall the sorbitan mono- used alone or in combination with stearate exceed 0.7 percent or the poly- polysorbate 80, whereby the maximum sorbate 60 exceed 0.46 percent, and no amount of the additives, alone or in combination of these emulsifiers shall combination, does not exceed 0.1 per- exceed 1 percent of the weight of the cent of the finished frozen dessert. cake icing or cake filling. (2) As an emulsifier in cakes and cake (d) To assure safe use of the additive, mixes, with or without one or a com- in addition to the other information re- bination of the following: quired by the Act: (i) Sorbitan monostearate. (1) The label of the additive and any (ii) Polysorbate 60. intermediate premixes shall bear: When used alone, the maximum (i) The name of the additive. amount of polysorbate 65 shall not ex- (ii) A statement of the concentration ceed 0.32 percent of the cake or cake or strength of the additive in any in- mix, on a dry-weight basis. When used termediate premixes. with sorbitan monostearate and/or (2) The label or labeling shall bear polysorbate 60, it shall not exceed 0.32 adequate directions to provide a final percent, nor shall the sorbitan mono- product that complies with the limita- stearate exceed 0.61 percent or the tions prescribed in paragraph (c) of this polysorbate 60 exceed 0.46 percent, and section. no combination of these emulsifiers [42 FR 14491, Mar. 15, 1977, as amended at 43 shall exceed 0.66 percent of the cake or FR 2871, Jan. 20, 1978]

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§ 172.840 Polysorbate 80. shall not exceed 300 milligrams from the recommended daily dose of the The food additive polysorbate 80 preparations. (polyoxyethylene (20) sorbitan monooleate), which is a mixture of (iii) In vitamin-mineral preparations polyoxyethylene ethers of mixed par- containing both calcium caseinate and tial oleic acid esters of sorbitol anhy- fat-soluble vitamins, whereby the max- drides and related compounds, may be imum intake of polysorbate 80 shall safely used in food in accordance with not exceed 475 milligrams from the rec- the following prescribed conditions: ommended daily dose of the prepara- (a) The food additive is manufactured tions. by reacting oleic acid (usually con- (5) As a surfactant in the production taining associated fatty acids) with of coarse crystal sodium chloride sorbitol to yield a product with a max- whereby the maximum amount of the imum acid number of 7.5 and a max- additive in the finished sodium chlo- imum water content of 0.5 percent, ride does not exceed 10 parts per mil- which is then reacted with ethylene lion. oxide. (6) In special dietary foods, as an (b) The food additive meets the fol- emulsifier for edible fats and oils, with lowing specifications: directions for use which provide for the ingestion of not more than 360 milli- Saponification number 45–55. grams of polysorbate 80 per day. Acid number 0–2. (7) As a solubilizing and dispersing Hydroxyl number 65–80. Oxyethylene content 65 percent–69.5 percent. agent for dill oil in canned spiced green beans, not to exceed 30 parts per mil- (c) The additive is used or intended lion. for use as follows: (8) As an emulsifier, alone or in com- (1) An emulsifier in ice cream, frozen bination with polysorbate 60, in custard, ice milk, fruit sherbet, and shortenings and edible oils intended for nonstandardized frozen desserts, when use in foods as follows, when standards used alone or in combination with of identity established under section polysorbate 65 whereby the maximum 401 of the act do not preclude such use: amount of the additives, alone or in (i) It is used alone in an amount not combination, does not exceed 0.1 per- to exceed 1 percent of the weight of the cent of the finished frozen dessert. finished shortening or oil. (2) In yeast-defoamer formulations (ii) It is used with polysorbate 60 in whereby the maximum amount of the any combination providing no more additive does not exceed 4 percent of than 1 percent of polysorbate 80 and no the finished yeast defoamer and the more than 1 percent of polysorbate 60, maximum amount of the additive in provided that the total combination the yeast from such use does not ex- does not exceed 1 percent of the fin- ceed 4 parts per million. ished shortening or oil. (3) As a solubilizing and dispersing (iii) The 1–percent limitation speci- agent in pickles and pickle products, fied in paragraph (c)(8) (i) and (ii) of whereby the maximum amount of the this section may be exceeded in premix additive does not exceed 500 parts per concentrates of shortening or edible oil million. if the labeling complies with the re- (4) As a solubilizing and dispersing quirements of paragraph (d) of this sec- agent in: tion. (i) Vitamin-mineral preparations (9) As an emulsifier in whipped edible containing calcium caseinate in the ab- oil topping with or without one or a sence of fat-soluble vitamins, whereby combination of the following: the maximum intake of polysorbate 80 (i) Sorbitan monostearate; shall not exceed 175 milligrams from (ii) Polysorbate 60; the recommended daily dose of the (iii) Polysorbate 65; preparations. (ii) Fat-soluble vitamins in vitamin whereby the maximum amount of the and vitamin-mineral preparations con- additive or additives used does not ex- taining no calcium caseinate, whereby ceed 0.4 percent of the weight of the the maximum intake of polysorbate 80 finished whipped edible oil topping.

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(10) It is used as a wetting agent in (a)(1) Polydextrose (CAS Reg. No. scald water for poultry defeathering, 68424–04–4) is a partially metabolizable followed by potable water rinse. The water-soluble polymer prepared by the concentration of the additive in the condensation of a melt which consists scald water does not exceed 0.0175 per- either of approximately 89 percent D- cent. glucose, 10 percent sorbitol, and 1 per- (11) As a dispersing agent in gelatin cent citric acid or of approximately 90 desserts and in gelatin dessert mixes, percent D-glucose, 10 percent sorbitol, whereby the amount of the additive and 0.1 percent phosphoric acid, on a does not exceed 0.082 percent on a dry- weight basis. weight basis. (2) Polydextrose may be partially (12) As an adjuvant added to herbi- neutralized with potassium hydroxide, cide use and plant-growth regulator or partially reduced by transition use dilutions by a grower or applicator metal catalytic hydrogenation in aque- prior to application of such dilutions to ous solution. the growing crop. Residues resulting from such use are exempt from the re- (b) The additive meets the specifica- quirement of a tolerance. When so used tions of the Food Chemicals Codex, 7th or intended for use, the additive shall ed. (2010), pp. 811–814, which is incor- be exempt from the requirements of porated by reference. The Director of paragraph (d)(1) of this section. the Office of the Federal Register ap- (13) As a defoaming agent in the prep- proves this incorporation by reference aration of the creaming mixture for in accordance with 5 U.S.C. 552(a) and 1 cottage cheese and lowfat cottage CFR part 51. You may obtain copies cheese, as identified in §§ 133.128 and from the United States Pharmacopeial 133.131 of this chapter, respectively, Convention, 12601 Twinbrook Pkwy., whereby the amount of the additive Rockville, MD 20852 (Internet address does not exceed .008 percent by weight http://www.usp.org). Copies may be ex- of the finished products. amined at the Food and Drug Adminis- (14) As a surfactant and wetting tration’s Main Library, 10903 New agent for natural and artificial colors Hampshire Ave., Bldg. 2, Third Floor, for use in barbecue sauce where the Silver Spring, MD 20993, 301–796–2039, or level of the additive does not exceed at the National Archives and Records 0.005 percent by weight of the barbecue Administration (NARA). For informa- sauce. tion on the availability of this mate- (d) To assure safe use of the additive, rial at NARA, call 202–741–6030 or go to: in addition to the other information re- http://www.archives.gov/federal-register/ quired by the Act: cfr/ibr-locations.html. (1) The label of the additive and any (c) When standards of identity estab- intermediate premixes shall bear: lished under section 401 of the act do (i) The name of the additive. not preclude such use, polydextrose (ii) A statement of the concentration may be used in accordance with cur- or strength of the additive in any in- rent good manufacturing practices as a termediate premixes. bulking agent, formulation aid, humec- (2) The label or labeling shall bear tant, and texturizer in all foods, except adequate directions to provide a final product that complies with the limita- meat and poultry, baby food, and in- tions prescribed in paragraph (c) of this fant formula. section. (d) If the food containing the additive purports to be or is represented for spe- [42 FR 14491, Mar. 15, 1977, as amended at 43 cial dietary uses, it shall be labeled in FR 2871, Jan. 20, 1978; 45 FR 58835, Sept. 5, compliance with part 105 of this chap- 1980; 46 FR 8466, Jan. 27, 1981] ter. § 172.841 Polydextrose. (e) The label and labeling of food a single serving of which would be ex- Polydextrose as identified in this section may be safely used in food in ac- pected to exceed 15 grams of the addi- cordance with the following prescribed tive shall bear the statement: ‘‘Sen- conditions: sitive individuals may experience a

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laxative effect from excessive con- sorbate 60, it shall not exceed 0.61 per- sumption of this product’’. cent, nor shall the polysorbate 65 exceed 0.32 percent or the polysorbate 60 [46 FR 30081, June 5, 1981, as amended at 59 FR 37421, July 22, 1994; 60 FR 54425, Oct. 24, exceed 0.46 percent, and no combina- 1995; 61 FR 14480, Apr. 2, 1996; 62 FR 30985, tion of the emulsifiers shall exceed 0.66 June 6, 1997; 63 FR 57597, Oct. 28, 1998; 65 FR percent of the weight of the cake or 64605, Oct. 30, 2000; 65 FR 79719, Dec. 20, 2000; cake mix, calculated on a dry-weight 72 FR 46564, Aug. 21, 2007; 78 FR 71464, Nov. 29, basis. 2013] (3) As an emulsifier, alone or in combination with polysorbate 60 in non- § 172.842 Sorbitan monostearate. standardized confectionery coatings The food additive sorbitan monostea- and standardized cacao products speci- rate, which is a mixture of partial ste- fied in §§ 163.123, 163.130, 163.135, 163.140, aric and palmitic acid esters of sorbitol 163.145, and 163.150 of this chapter, as anhydrides, may be safely used in or on follows: food in accordance with the following (i) It is used alone in an amount not prescribed conditions: to exceed 1 percent of the weight of the (a) The food additive is manufactured finished nonstandardized confectionery by reacting stearic acid (usually con- coating or standardized cacao product. taining associated fatty acids, chiefly (ii) It is used with polysorbate 60 in palmitic) with sorbitol to yield essen- any combination of up to 1 percent sor- tially a mixture of esters. bitan monostearate and up to 0.5 per- (b) The food additive meets the fol- cent polysorbate 60 provided that the lowing specifications: total combination does not exceed 1 Saponification number, 147–157 percent of the weight of the finished Acid number, 5–10 nonstandardized confectionery coating Hydroxyl number, 235–260 or standardized cacao product. (c) It is used or intended for use, (4) As an emulsifier in cake icings alone or in combination with poly- and cake fillings, with or without one sorbate 60 as follows: or a combination of the following: (1) As an emulsifier in whipped edible (i) Polysorbate 65. oil topping with or without one or a (ii) Polysorbate 60. combination of the following: When used alone, the maximum (i) Polysorbate 60; amount of sorbitan monostearate shall (ii) Polysorbate 65; not exceed 0.7 percent of the weight of (iii) Polysorbate 80; the cake icing or cake filling. When whereby the maximum amount of the used with polysorbate 65 and/or poly- additive or additives used does not ex- sorbate 60, it shall not exceed 0.7 per- ceed 0.4 percent of the weight of the cent, nor shall the polysorbate 65 ex- finished whipped edible oil topping; exceed 0.32 percent or the polysorbate 60 cept that a combination of the additive exceed 0.46 percent, and no combina- with polysorbate 60 may be used in ex- tion of these emulsifiers shall exceed 1 cess of 0.4 percent: Provided, That the percent of the weight of the cake icing amount of the additive does not exceed or cake filling. 0.27 percent and the amount of poly- (5) As an emulsifier in solid-state, ed- sorbate 60 does not exceed 0.77 percent ible vegetable fat-water emulsions in- of the weight of the finished whipped tended for use as substitutes for milk edible oil topping. or cream in beverage coffee, with or (2) As an emulsifier in cakes and cake without one or a combination of the mixes, with or without one or a com- following: bination of the following: (i) Polysorbate 60. (i) Polysorbate 65. (ii) Polysorbate 65. (ii) Polysorbate 60. The maximum amount of the additive When used alone, the maximum or additives shall not exceed 0.4 per- amount of sorbitan monostearate shall cent by weight of the finished edible not exceed 0.61 percent of the cake or vegetable fat-water emulsion. cake mix, on a dry-weight basis. When (6) It is used alone as a rehydration used with polysorbate 65 and/or poly- aid in the production of active dry

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yeast in an amount not to exceed 1 per- (ii) Dried egg white at a level not to cent by weight of the dry yeast. exceed 0.5 percent. (7) As an emulsifier, alone or in com- (iii) Whipped vegetable oil topping at bination with polysorbate 60, in the a level not to exceed 0.3 percent of the minimum quantity required to accom- weight of the finished whipped vege- plish the intended effect, in formula- table oil topping. tions of white mineral oil conforming (3) As a conditioning agent in dehy- with § 172.878 and/or petroleum wax drated potatoes in an amount not to conforming with § 172.886 for use as pro- exceed 0.5 percent by weight thereof. tective coatings on raw fruits and vege- (d) To assure safe use of the additive: tables. (1) The label and labeling of the food (d) To assure safe use of the additive, additive and any intermediate premix in addition to the other information re- prepared therefrom shall bear, in addi- quired by the Act: tion to the other information required (1) The label of the additive and any by the act, the following: intermediate premixes shall bear: (i) The name of the additive. (i) The name of the additive. (ii) A statement of the concentration (ii) A statement of the concentration or strength of the additive in any in- or strength of the additive in any intermediate premixes. termediate premixes. (2) The label or labeling of the food (2) The label or labeling shall bear adequate directions to provide a final additive shall also bear adequate direc- product that complies with the limitations of use to provide a finished food tions prescribed in paragraph (c) of this that complies with the limitations pre- section. scribed in paragraph (c) of this section. [42 FR 14491, Mar. 15, 1977, as amended at 43 § 172.846 Sodium stearoyl lactylate. FR 2871, Jan. 20, 1978] The food additive sodium stearoyl § 172.844 Calcium stearoyl-2-lactylate. lactylate (CAS Reg. No. 25–383–997) may be safely used in food in accordance The food additive calcium stearoyl-2- with the following prescribed condi- lactylate may be safely used in or on tions: food in accordance with the following (a) The additive, which is a mixture prescribed conditions: of sodium salts of stearoyl lactylic (a) The additive, which is a mixture acids and minor proportions of sodium of calcium salts of stearoyl lactylic salts of related acids, is manufactured acids and minor proportions of other by the reaction of stearic acid and lac- calcium salts of related acids, is manu- tic acid and conversion to the sodium factured by the reaction of stearic acid and lactic acid and conversion to the salts. calcium salts. (b) The additive meets the specifica- (b) The additive meets the following tions of the ‘‘Food Chemicals Codex,’’ specifications: 3d Ed. (1981), pp. 300–301, which is incorporated by reference. Copies may be Acid number, 50–86. obtained from the National Academy Calcium content, 4.2–5.2 percent. Press, 2101 Constitution Ave. NW., Lactic acid content, 32–38 percent. Washington, DC 20418, or may be exam- Ester number, 125–164. ined at the National Archives and (c) It is used or intended for use as Records Administration (NARA). For follows: information on the availability of this (1) As a dough conditioner in yeast- material at NARA, call 202–741–6030, or leavened bakery products and prepared go to: http://www.archives.gov/ mixes for yeast-leavened bakery prod- federallregister/ ucts in an amount not to exceed 0.5 codeloflfederallregulations/ part for each 100 parts by weight of ibrllocations.html. flour used. (c) It is used or intended for use as (2) As a whipping agent in: follows when standards of identity es- (i) Liquid and frozen egg white at a tablished under section 401 of the Act level not to exceed 0.05 percent. do not preclude such use:

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(1) As a dough strengthener, emulsi- acid derived from tall oil fatty acids fier, or processing aid in baked prod- meeting the requirements of § 172.862. ucts, pancakes, and waffles, in an (b) They are used as emulsifiers, plas- amount not to exceed 0.5 part for each ticizers, or surface-active agents in the 100 parts by weight of flour used. following foods, when standards of (2) As a surface-active agent, emulsi- identity do not preclude their use: fier, or stabilizer in icings, fillings, puddings, and toppings, at a level not Foods Limitations to exceed 0.2 percent by weight of the Bakery mixes ...... finished food. Baked products ...... Cake icings, fillings, and toppings (3) As an emulsifier or stabilizer in Dehydrated fruits and vegetables liquid and solid edible fat-water emul- Dehydrated fruit and vegetable sions intended for use as substitutes juices. Edible vegetable fat-water emul- As substitutes for milk or for milk or cream in beverage coffee, at sions. cream in beverage cof- a level not to exceed 0.3 percent by fee. weight of the finished edible fat-water Frozen desserts ...... emulsion. Liquid shortening ...... For household use. Pancake mixes ...... (4) As a formulation aid, processing Precooked instant rice ...... aid, or surface-active agent in dehy- Pudding mixes ...... drated potatoes, in an amount not to exceed 0.5 percent of the dry weight of (c) They are used in an amount not the food. greater than required to produce the (5) As an emulsifier, stabilizer, or intended physical or technical effect, texturizer in snack dips, at a level not and they may be used with shortening to exceed 0.2 percent by weight of the and edible fats and oils when such are finished product. required in the foods identified in para- (6) As an emulsifier, stabilizer, or graph (b) of this section. texturizer in cheese substitutes and § 172.850 Lactylated fatty acid esters imitations and cheese product sub- of glycerol and propylene glycol. stitutes and imitations, at a level not to exceed 0.2 percent by weight of the The food additive lactylated fatty finished food. acid esters of glycerol and propylene (7) As an emulsifier, stabilizer, or glycol may be safely used in food in ac- texturizer in sauces or gravies, and the cordance with the following prescribed products containing the same, in an conditions: amount not to exceed 0.25 percent by (a) The additive is a mixture of esters weight of the finished food. produced by the lactylation of a product obtained by reacting edible fats or (8) In prepared mixes for each of the oils with propylene glycol. foods listed in paragraphs (c) (1) (b) The additive meets the following through (7) of this section, provided the specifications: Water insoluble com- additive is used only as specified in bined lactic acid, 14–18 percent; and each of those paragraphs. acid number, 12 maximum. (9) As an emulsifier, stabilizer, or (c) It is used in amounts not in excess texturizer in cream liqueur drinks, at a of that reasonably required to produce level not to exceed 0.5 percent by the intended physical effect as an weight of the finished product. emulsifier, plasticizer, or surface-ac- [45 FR 51767, Aug. 5, 1980, as amended at 49 tive agent in food. FR 10105, Mar. 19, 1984; 50 FR 49536, Dec. 3, 1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333, Jan. § 172.852 Glyceryl-lacto esters of fatty 27, 1986; 65 FR 60859, Oct. 13, 2000] acids. Glyceryl-lacto esters of fatty acids § 172.848 Lactylic esters of fatty acids. (the lactic acid esters of mono- and Lactylic esters of fatty acids may be diglycerides) may be safely used in safely used in food in accordance with food in accordance with the following the following prescribed conditions: prescribed conditions: (a) They are prepared from lactic (a) They are manufactured from glyc- acid and fatty acids meeting the re- erin, lactic acid, and fatty acids con- quirements of § 172.860(b) and/or oleic forming with § 172.860 and/or oleic acid

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derived from tall oil fatty acids con- § 172.856 Propylene glycol mono- and forming with § 172.862 and/or edible fats diesters of fats and fatty acids. and oils. Propylene glycol mono- and diesters (b) They are used in amounts not in of fats and fatty acids may be safely excess of those reasonably required to used in food, subject to the following accomplish their intended physical or prescribed conditions: technical effect as emulsifiers and plas- (a) They are produced from edible ticizers in food. fats and/or fatty acids in compliance with § 172.860 and/or oleic acid derived § 172.854 Polyglycerol esters of fatty from tall oil fatty acids in compliance acids. with § 172.862. Polyglycerol esters of fatty acids, up (b) They are used in food in amounts to and including the decaglycerol not in excess of that reasonably re- esters, may be safely used in food in ac- quired to produce their intended effect. cordance with the following prescribed conditions: § 172.858 Propylene glycol alginate. (a) They are prepared from corn oil, The food additive propylene glycol cottonseed oil, lard, palm oil from alginate (CAS Reg. No. 9005–37–2) may fruit, peanut oil, safflower oil, sesame be used as an emulsifier, flavoring ad- oil, soybean oil, and tallow and the juvant, formulation aid, stabilizer, sur- fatty acids derived from these sub- factant, or thickener in foods in ac- stances (hydrogenated and nonhydro- cordance with the following prescribed genated) meeting the requirements of conditions: § 172.860(b) and/or oleic acid derived (a) The additive meets the specifica- from tall oil fatty acids meeting the tions of the Food Chemicals Codex, 3d Ed. (1981), p. 256, which is incorporated requirements of § 172.862. by reference (Copies are available from (b) They are used as emulsifiers in the National Academy Press, 2101 Con- food, in amounts not greater than that stitution Ave. NW., Washington, DC required to produce the intended phys- 20418, or available for inspection at the ical or technical effect. National Archives and Records Admin- (c) Polyglycerol esters of a mixture istration (NARA). For information on of stearic, oleic, and coconut fatty the availability of this material at acids are used as a cloud inhibitor in NARA, call 202–741–6030, or go to: http:// vegetable and salad oils when use is www.archives.gov/federallregister/ not precluded by standards of identity. codeloflfederallregulations/ The fatty acids used in the production ibrllocations.html.), and the additional of the polyglycerol esters meet the re- specification that it shall have up to 85 quirements of § 172.860(b), and the percent of the carboxylic acid groups polyglycerol esters are used at a level esterified with the remaining groups not in excess of the amount required to either free or neutralized. perform its cloud-inhibiting effect. (b) The additive is used or intended Oleic acid derived from tall oil fatty for use in the following foods as defined acids conforming with § 172.862 may be in § 170.3(n) of this chapter, when stand- used as a substitute for or together ards of identity established under sec- with the oleic acid permitted by this tion 401 of the act do not preclude such paragraph. use: (d) Polyglycerol esters of butter oil (1) As a stabilizer in frozen dairy desserts, in fruit and water ices, and in fatty acids are used as emulsifiers in confections and frostings at a level not combination with other approved emul- to exceed 0.5 percent by weight of the sifiers in dry, whipped topping base. finished product. The fatty acids used in the production (2) As an emulsifier, flavoring adju- of the polyglycerol esters meet the re- vant, stabilizer, or thickener in baked quirements of § 172.860(b), and the goods at a level not to exceed 0.5 per- polyglycerol esters are used at a level cent by weight of the finished product. not in excess of the amount required to (3) As an emulsifier, stabilizer, or perform their emulsifying effect. thickener in cheeses at a level not to

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exceed 0.9 percent by weight of the fin- propanol) may be used in the prepara- ished product. tion of sucrose fatty acid esters. (4) As an emulsifier, stabilizer, or (b) Sucrose fatty acid esters meet the thickener in fats and oils at a level not following specifications: to exceed 1.1 percent by weight of the (1) The total content of mono-, di-, finished product. and tri-esters is not less than 80 per- (5) As an emulsifier, stabilizer, or cent as determined by a method title thickener in gelatins and puddings at a ‘‘Sucrose Fatty Acid Esters, Method of level not to exceed 0.6 percent by Assay,’’ which is incorporated by ref- weight of the finished product. erence. Copies are available from the (6) As a stabilizer or thickener in gra- Center for Food Safety and Applied Nu- vies and in sweet sauces at a level not trition (HFS–200), Food and Drug Ad- to exceed 0.5 percent by weight of the ministration, 5001 Campus Dr., College finished product. Park, MD 20740, or available for inspec- (7) As a stabilizer in jams and jellies tion at the National Archives and at a level not to exceed 0.4 percent by Records Administration (NARA). For weight of the finished product. information on the availability of this (8) As an emulsifier, stabilizer, or material at NARA, call 202–741–6030, or thickener in condiments and relishes go to: at a level not to exceed 0.6 percent by http://www.archives.gov/ weight of the finished product. federallregister/ (9) As a flavoring adjunct or adjuvant codeloflfederallregulations/ in seasonings and flavors at a level not ibrllocations.html. to exceed 1.7 percent by weight of the (2) The free sucrose content is not finished product. more than 5 percent as determined by (10) As an emulsifier, flavoring adju- Test S.2 in the method titled ‘‘Sucrose vant, formulation aid, stabilizer or Fatty Acid Esters, Method of Assay,’’ thickener, or surface active agent in which is incorporated by reference. The other foods, where applicable, at a availability of this incorporation by level not to exceed 0.3 percent by reference is given in paragraph (b)(1) of weight of the finished product. this section. (c) To ensure safe use of the additive, (3) The acid value is not more than 6. the label of the food additive container (4) The residue on ignition (sulfated shall bear, in addition to the other in- ash) is not more than 2 percent. formation required by the act: (5) The total ethyl acetate content is (1) The name of the additive, ‘‘pro- not more than 350 parts per million as pylene glycol alginate’’ or ‘‘propylene determined by a method titled ‘‘Deter- glycol ester of alginic acid’’. mination of Ethyl Acetate,’’ which is (2) Adequate directions for use. incorporated by reference. Copies are [47 FR 29950, July 9, 1982] available from the Center for Food Safety and Applied Nutrition (HFS– § 172.859 Sucrose fatty acid esters. 200), Food and Drug Administration, Sucrose fatty acid esters identified in 5001 Campus Dr., College Park, MD this section may be safely used in ac- 20740, or available for inspection at the cordance with the following prescribed National Archives and Records Admin- conditions: istration (NARA). For information on (a) Sucrose fatty acid esters are the the availability of this material at mono-, di-, and tri-esters of sucrose NARA, call 202–741–6030, or go to: http:// with fatty acids and are derived from www.archives.gov/federallregister/ sucrose and edible tallow or hydro- codeloflfederallregulations/ genated edible tallow or edible vege- ibrllocations.html. table oils. The only solvents which (6) Arsenic is not more than 3 parts may be used in the preparation of su- per million. crose fatty acid esters are those gen- (7) Total heavy metal content (as Pb) erally recognized as safe in food or reg- is not more than 50 parts per million. ulated for such use by an appropriate (8) Lead is not more than 10 parts per section in this part. Ethyl acetate or million. methyl ethyl ketone or dimethyl sulf- (9) The total content of methyl ethyl oxide and isobutyl alcohol (2-methyl-1- ketone or of methanol shall not be

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more than 10 parts per million as deter- (1) As emulsifiers as defined in mined by a method titled ‘‘Methyl § 170.3(o)(8) of this chapter, or as stabi- Ethyl Ketone Test; Methyl Alcohol lizers as defined in § 170.3(o)(28) of this Test,’’ which is incorporated by ref- chapter, in baked goods and baking erence. Copies are available from the mixes as defined in § 170.3(n)(1) of this Center for Food Safety and Applied Nu- chapter, in chewing gum as defined in trition (HFS–200), Food and Drug Ad- § 170.3(n)(6) of this chapter, in coffee ministration, 5001 Campus Dr., College and tea beverages with added dairy in- Park, MD 20740, or available for inspec- gredients and/or dairy product ana- tion at the National Archives and logues, in confections and frostings as Records Administration (NARA). For defined in § 170.3(n)(9) of this chapter, information on the availability of this in dairy product analogues as defined material at NARA, call 202–741–6030, or in § 170.3(n)(10) of this chapter, in frozen go to: http://www.archives.gov/ dairy desserts and mixes as defined in federallregister/ § 170.3(n)(20) of this chapter, and in codeloflfederallregulations/ whipped milk products. ibrllocations.html. (2) As texturizers as defined in (10) The total dimethyl sulfoxide con- § 170.3(o)(32) of this chapter in biscuit mixes, in chewing gum as defined in tent is not more than 2 parts per mil- § 170.3(n)(6) of this chapter, in confec- lion as determined by a method enti- tions and frostings as defined in tled ‘‘Determination of Dimethyl Sulf- § 170.3(n)(9) of this chapter, and in oxide,’’ which is incorporated by ref- surimi-based fabricated seafood prod- erence. Copies are available from the ucts. Center for Food Safety and Applied Nu- (3) As components of protective coat- trition (HFS–200), Food and Drug Ad- ings applied to fresh apples, avocados, ministration, 5001 Campus Dr., College bananas, banana plantains, limes, mel- Park, MD 20740, or available for inspec- ons (honeydew and cantaloupe), pa- tion at the National Archives and paya, peaches, pears, pineapples, and Records Administration (NARA). For plums to retard ripening and spoiling. information on the availability of this (d) Sucrose fatty acid esters are used material at NARA, call 202–741–6030, or in accordance with current good manu- go to: http://www.archives.gov/ facturing practice and in an amount federallregister/ not to exceed that reasonably required codeloflfederallregulations/ to accomplish the intended effect. ibrllocations.html. (11) The total isobuytl alcohol (2- [47 FR 55475, Dec. 10, 1982, as amended at 48 methyl-1-propanol) content is not more FR 38226, Aug. 23, 1983; 52 FR 10883, Apr. 6, 1987; 53 FR 22294, 22297, June 15, 1988; 54 FR than 10 parts per million as determined 24897, June 12, 1989; 60 FR 44756, Aug. 29, 1995] by a method entitled ‘‘Determination of Isobutyl Alcohol,’’ which is incor- § 172.860 Fatty acids. porated by reference. Copies are avail- The food additive fatty acids may be able from the Center for Food Safety safely used in food and in the manufac- and Applied Nutrition (HFS–200), Food ture of food components in accordance and Drug Administration, 5001 Campus with the following prescribed condi- Dr., College Park, MD 20740, or avail- tions: able for inspection at the National Ar- (a) The food additive consists of one chives and Records Administration or any mixture of the following (NARA). For information on the avail- straight-chain monobasic carboxylic ability of this material at NARA, call acids and their associated fatty acids 202–741–6030, or go to: http:// manufactured from fats and oils de- www.archives.gov/federallregister/ rived from edible sources: Capric acid, codeloflfederallregulations/ caprylic acid, lauric acid, myristic ibrllocations.html. acid, oleic acid, palmitic acid, and ste- (c) Sucrose fatty acid esters may be aric acid. used as follows when standards of iden- (b) The food additive meets the fol- tity established under section 401 of lowing specifications: the Federal Food, Drug, and Cosmetic (1) Unsaponifiable matter does not Act do not preclude such use: exceed 2 percent.

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(2) It is free of chick-edema factor: ists,’’ Volume 50 (No. 1), pages 216–218 (i) As evidenced during the bioassay (1967), or the modified method using a method for determining the chick- sulfuric acid clean-up procedure, as de- edema factor as prescribed in para- scribed in the ‘‘Journal of the Associa- graph (c)(2) of this section; or tion of the Offical Analytical Chem- (ii) As evidenced by the absence of ists,’’ Volume 51 (No. 2), pages 489–490 chromatographic peaks with a reten- (1968), which are incorporated by ref- tion time relative to aldrin (RA) be- erence. See paragraph (c)(2) of this sec- tween 10 and 25, using the gas tion for availability of these ref- chromatographic-electron capture erences. method prescribed in paragraph (c)(3) (d) It is used or intended for use as of this section. If chromatographic follows: peaks are found with RA values be- (1) In foods as a lubricant, binder, tween 10 and 25, the food additive shall and as a defoaming agent in accordance meet the requirements of the bioassay with good manufacturing practice. method prescribed in paragraph (c)(2) (2) As a component in the manufac- of this section for determining chick- ture of other food-grade additives. edema factor. (e) To assure safe use of the additive, (c) For the purposes of this section: the label and labeling of the additive (1) Unsaponifiable matter shall be de- and any premix thereof shall bear, in termined by the method described in addition to the other information re- the 13th Ed. (1980) of the ‘‘Official quired by the act, the following: Methods of Analysis of the Association (1) The common or usual name of the of Official Analytical Chemists,’’ which acid or acids contained therein. is incorporated by reference. Copies are (2) The words ‘‘food grade,’’ in jux- available from the AOAC INTER- taposition with and equally as promi- NATIONAL, 481 North Frederick Ave., nent as the name of the acid. suite 500, Gaithersburg, MD 20877, or available for inspection at the National [42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, Archives and Records Administration 1984; 54 FR 24897, June 12, 1989] (NARA). For information on the availability of this material at NARA, call § 172.861 Cocoa butter substitute from 202–741–6030, or go to: http:// coconut oil, palm kernel oil, or both www.archives.gov/federallregister/ oils. codeloflfederallregulations/ The food additive, cocoa butter sub- ibrllocations.html. stitute from coconut oil, palm kernel (2) Chick-edema factor shall be deter- oil, or both oils, may be safely used in mined by the bioassay method de- food in accordance with the following scribed in ‘‘Official Methods of Anal- conditions: ysis of the Association of Official Ana- (a) Cocoa butter substitute from co- lytical Chemists,’’ 13th Ed. (1980), sec- conut oil, palm kernel oil (CAS Reg. tions 28.127–28.130, which is incor- No. 85665–33–4), or both oils is a mixture porated by reference. Copies may be of triglycerides. It is manufactured by obtained from the AOAC INTER- esterification of glycerol with food- NATIONAL, 481 North Frederick Ave., grade fatty acids (complying with suite 500, Gaithersburg, MD 20877, or § 172.860) derived from edible coconut may be examined at the National Ar- oil, edible palm kernel oil, or both oils. chives and Records Administration (b) The ingredient meets the fol- (NARA). For information on the avail- lowing specifications: ability of this material at NARA, call 202–741–6030, or go to: http:// Acid number: Not to exceed 0.5. www.archives.gov/federallregister/ Saponification number: 220 to 260. code of federal regulations/ Iodine number: Not to exceed 3. l l l ° ibrllocations.html. Melting range: 30 to 44 C. (3) The gas chromatographic-electron (c) The ingredient is used or intended capture method for testing fatty acids for use as follows: for chick-edema shall be the method (1) As coating material for sugar, described in the ‘‘Journal of the Asso- table salt, vitamins, citric acid, suc- ciation of Official Analytical Chem- cinic acid, and spices; and

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(2) In compound coatings, cocoa which is incorporated by reference. creams, cocoa-based sweets, toffees, Copies may be obtained from the Amer- caramel masses, and chewing sweets as ican Society for Testing Materials, 100 defined in § 170.3 (n)(9) and (n)(38) of Barr Harbor Dr., West Conshohocken, this chapter, except that the ingredient Philadelphia, PA 19428-2959, or may be may not be used in a standardized food examined at the National Archives and unless permitted by the standard of Records Administration (NARA). For identity. information on the availability of this (d) The ingredient is used in accord- material at NARA, call 202–741–6030, or ance with current good manufacturing go to: http://www.archives.gov/ practice and in an amount not to ex- federallregister/ ceed that reasonably required to ac- codeloflfederallregulations/ complish the intended effect. ibrllocations.html. [56 FR 66970, Dec. 27, 1991; 57 FR 2814, Jan. 23, (3) The requirements for absence of 1992] chick-edema factor as prescribed in § 172.860. § 172.862 Oleic acid derived from tall (c) It is used or intended for use as oil fatty acids. follows: The food additive oleic acid derived (1) In foods as a lubricant, binder, from tall oil fatty acids may be safely and defoaming agent in accordance used in food and as a component in the with good manufacturing practice. manufacture of food-grade additives in (2) As a component in the manufac- accordance with the following pre- ture of other food-grade additives. scribed conditions: (d) To assure safe use of the additive, (a) The additive consists of purified the label and labeling of the additive oleic acid separated from refined tall and any premix thereof shall bear, in oil fatty acids. addition to the other information re- (b) The additive meets the following quired by the Act, the following: specifications: (1) The common or usual name of the (1) Specifications for oleic acid pre- acid. scribed in the Food Chemicals Codex, (2) The words ‘‘food grade’’ in jux- 7th ed. (2010), pp. 743–744, which is in- taposition with and equally as promi- corporated by reference, except that nent as the name of the acid. titer (solidification point) shall not exceed 13.5 °C and unsaponifiable matter [42 FR 14491, Mar. 15, 1977, as amended at 49 shall not exceed 0.5 percent. The Direc- FR 10105, Mar. 19, 1984; 78 FR 71465, Nov. 29, tor of the Office of the Federal Register 2013] approves this incorporation by ref- § 172.863 Salts of fatty acids. erence in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may ob- The food additive salts of fatty acids tain copies from the United States may be safely used in food and in the Pharmacopeial Convention, 12601 manufacture of food components in ac- Twinbrook Pkwy., Rockville, MD 20852 cordance with the following prescribed (Internet address http://www.usp.org). conditions: Copies may be examined at the Food (a) The additive consists of one or and Drug Administration’s Main Li- any mixture of two or more of the alu- brary, 10903 New Hampshire Ave., Bldg. minum, calcium, magnesium, potas- 2, Third Floor, Silver Spring, MD 20993, sium, and sodium salts of the fatty 301–796–2039, or at the National Ar- acids conforming with § 172.860 and/or chives and Records Administration oleic acid derived from tall oil fatty (NARA). For information on the avail- acids conforming with § 172.862. ability of this material at NARA, call (b) The food additive is used or in- 202–741–6030 or go to: http:// tended for use as a binder, emulsifier, www.archives.gov/federal-register/cfr/ibr- and anticaking agent in food in accord- locations.html. ance with good manufacturing prac- (2) The resin acid content does not tice. exceed 0.01 as determined by ASTM (c) To assure safe use of the additive, method D1240–82, ‘‘Standard Test Meth- the label and labeling of the additive od for Rosin Acids in Fatty Acids,’’ and any premix thereof shall bear, in

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addition to the other information re- (3) n-Octyl; manufactured by the quired by the Act, the following: hydrodimerization of 1,3-butadiene, fol- (1) The common or usual name of the lowed by catalytic hydrogenation of fatty acid salt or salts contained there- the resulting dienol, and distillation to in. produce n-octyl alcohol with a min- (2) The words ‘‘food grade,’’ in jux- imum purity of 99 percent. The analyt- taposition with and equally as promi- ical method for n-octyl alcohol entitled nent as the name of the salt. ‘‘Test Method [Normal-octanol]’’ dated October 2003, and printed by Kuraray § 172.864 Synthetic fatty alcohols. Co., Ltd., is incorporated by reference. Synthetic fatty alcohols may be safe- The Director of the Office of the Fed- ly used in food and in the synthesis of eral Register approves this incorpora- food components in accordance with tion by reference in accordance with 5 the following prescribed conditions: U.S.C. 552(a) and 1 CFR part 51. You (a) The food additive consists of any may obtain a copy from the Office of one of the following fatty alcohols: Food Additive Safety, 5001 Campus Dr., (1) Hexyl, octyl, decyl, lauryl, College Park, MD 20740, or you may ex- myristyl, cetyl, and stearyl; manufac- amine a copy at the Food and Drug Ad- tured by fractional distillation of alco- ministration’s Main Library, 10903 New hols obtained by a sequence of oxida- Hampshire Ave., Bldg. 2, Third Floor, tion and hydrolysis of organo-alu- Silver Spring, MD 20993, 301–796–2039, or minums generated by the controlled re- at the National Archives and Records action of low molecular weight Administration (NARA). For informa- trialkylaluminum with purified ethyl- tion on the availability of this mate- ene (minimum 99 percent by volume rial at NARA, call 202–741–6030, or go to http://www.archives.gov/federallregister/ C2H4), and utilizing the hydrocarbon solvent as defined in paragraph (b) of codeloflfederallregulations/ this section, such that: ibrllocations.html. (i) Hexyl, octyl, decyl, lauryl, and (b) The hydrocarbon solvent used in myristyl alcohols contain not less than the process described in paragraph 99 percent of total alcohols and not less (a)(1) of this section is a mixture of liq- than 96 percent of straight chain alco- uid hydrocarbons essentially paraffinic hols. Any nonalcoholic impurities are in nature, derived from petroleum and primarily paraffins. refined to meet the specifications de- (ii) Cetyl and stearyl alcohols con- scribed in paragraph (b)(1) of this sec- tain not less than 98 percent of total tion when subjected to the procedures alcohols and not less than 94 percent of described in paragraph (b) (2) and (3) of this section. straight chain alcohols. Any non- (1) The hydrocarbon solvent meets alcoholic impurities are primarily the following specifications: paraffins. (i) Boiling-point range: 175 °C–275 °C. (iii) The synthetic fatty alcohols con- (ii) Ultraviolet absorbance limits as tain no more than 0.1 weight percent of follows: total diols as determined by a method available upon request from the Com- Maximum missioner of Food and Drugs. absorbance per (2) Hexyl, octyl, and decyl; manufac- Wavelength (millicrons) centimeter tured by fractional distillation of alco- optical path length hols obtained by a sequence of oxidation, hydrolysis, and catalytic hydro- 280–289 ...... 0.15 genation (catalyst consists of copper, 290–299 ...... 12 300–359 ...... 05 chromium, and nickel) of organo-alu- 360–400 ...... 02 minums generated by the controlled reaction of low molecular weight (2) Use ASTM method D86–82, trialkylaluminum with purified ethyl- ‘‘Standard Method for Distillation of ene (minimum 99 percent by volume Petroleum Products,’’ which is incor- C2H4), and utilizing an external coolant porated by reference, to determine such that these alcohols meet the spec- boiling point range. Copies of the ma- ifications prescribed in paragraph (a)(1) terial incorporated by reference may (i) and (iii) of this section. be obtained from the American Society

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for Testing Materials, 100 Barr Harbor Tuberculin syringe. 1-milliliter capacity, Dr., West Conshohocken, Philadelphia, with 3-inch, 22-gauge needle. PA 19428-2959, or may be examined at Volumetric flask. 5-milliliter capacity. Spectrophotometric cells. Fused quartz the National Archives and Records Ad- ground glass stoppered cells, optical path ministration (NARA). For information length in the range of 1.000 centimeter ±0.005 on the availability of this material at centimeter. With distilled water in the cells, NARA, call 202–741–6030, or go to: http:// determine any absorbance difference. www.archives.gov/federallregister/ Spectrophotometer. Spectral range 250 milli- codeloflfederallregulations/ microns—400 millimicrons with spectral slit ibrllocations.html. width of 2 millimicrons or less: under instrument operating conditions for these absorb- (3) The analytical method for deter- ance measurements, the spectrophotometer mining ultraviolet absorbance limits is shall also meet the following performance as follows: requirements: Absorbance repeatability, ±0.01 at 0.4 ab- GENERAL INSTRUCTIONS sorbance. Absorbance accuracy, 1 ±0.05 at 0.4 absorb- All glassware should be scrupulously ance. cleaned to remove all organic matter such as Wavelength repeatability, ±0.2 milli- oil, grease, detergent residues, etc. Examine micron. all glassware, including stoppers and stop- Wavelength accuracy, ±1.0 millimicron. cocks, under ultraviolet light to detect any Nitrogen cylinder. Water-pumped or equiva- residual fluorescent contamination. As a pre- lent purity nitrogen in cylinder equipped cautionary measure, it is recommended prac- with regulator and valve to control flow at 5 tice to rinse all glassware with purified iso- p.s.i.g. octane immediately before use. No grease is to be used on stopcocks or joints. Great care REAGENTS AND MATERIALS to avoid contamination of hydrocarbon sol- Organic solvents. All solvents used through- vent samples in handling and to assure about the procedure shall meet the specifica- sence of any extraneous material arising tions and tests described in this specifica- from inadequate packaging is essential. Be- tion. The isooctane, benzene, hexane, and 1,2- cause some of the polynuclear hydrocarbons dichloroethane designated in the list fol- sought in this test are very susceptible to lowing this paragraph shall pass the fol- photo-oxidation, the entire procedure is to lowing test: be carried out under subdued light. To the specified quantity of solvent in a 250-milliliter beaker, add 1 milliliter of puri- APPARATUS fied n-hexadecane and evaporate in the vacu- Chromatographic tube. 450 millimeters in um oven under a stream of nitrogen. Dis- length (packing section), inside diameter 19 continue evaporation when not over 1 milli- millimeters ±1 millimeter, equipped with a liter of residue remains. (To the residue from wad of clean Pyrex brand filtering wool (Cor- benzene add a 5-milliliter portion of purified ning Glass Works Catalog No. 3950 or equiva- isooctane, reevaporate, and repeat once to lent). The tube shall contain a 250-milliliter insure complete removal of benzene.) reservoir and a 2-millimeter tetrafluoro- Dissolve the 1 milliliter of hexadecane res- ethylene polymer stopcock at the opposite idue in isooctane and make to 5 milliliters end. Overall length of the tube is 670 millimeters. 1 As determined by using potassium chro- Stainless steel rod. 2 feet in length, 2 to 4 mate for reference standard and described in millimeters in diameter. National Bureau of Standards Circular 484, Vacuum oven. Similar to Labline No. 3610 Spectrophotometry, U.S. Department of but modified as follows: A copper tube one- Commerce, (1949). The accuracy is to be de- fourth inch in diameter and 13 inches in termined by comparison with the standard length is bent to a right angle at the 4-inch values at 290, 345, and 400 millimicrons. Cir- point and plugged at the opposite end; eight cular 484 is incorporated by reference. Copies copper tubes one-eighth inch in diameter and are available from the Center for Food Safe- 5 inches in length are silver soldered in ty and Applied Nutrition (HFS–200), Food drilled holes (one-eighth inch in diameter) to and Drug Administration, 5001 Campus Dr., the one-fourth-inch tube, one on each side at College Park, MD 20740, or available for in- the 5-, 7.5-, 10- and 12.5-inch points; the one- spection at the National Archives and eighth-inch copper tubes are bent to conform Records Administration (NARA). For infor- with the inner periphery of the oven. mation on the availability of this material Beakers. 250-milliliter and 500-milliliter ca- at NARA, call 202–741–6030, or go to: http:// pacity. www.archives.gov/federallregister/ Graduated cylinders. 25-milliliter, 50-milli- codeloflfederallregulations/ liter, and 150-milliliter capacity. ibrllocations.html.

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volume. Determine the absorbance in the 1- out the procedure without a sample. Record centimeter path length cells compared to the absorbance in the wavelength range of isooctane as reference. The absorbance of the 280 to 400 millimicrons. Typical reagent solution of the solvent residue shall not ex- blank absorbance in this range should not ceed 0.02 per centimeter path length between exceed 0.04 in the 280 to 299 millimicron 280 and 300 mμ and shall not exceed 0.01 per range, 0.02 in the 300 to 359 millimicron centimeter path length between 300 and 400 range, and 0.01 in the 360 to 400 millimicron mμ. range. If the characteristic benzene peaks in Isooctane (2,2,4-trimethylpentane). Use 10 the 250 to 260 millimicron region are present, milliliters for the test described in the pre- remove the benzene by the procedure de- ceding paragraph. If necessary, isooctane scribed above under ‘‘Reagents and Mate- may be purified by passage through a column rials,’’ ‘‘Organic Solvents,’’ and record ab- of activated silica gel (Grade 12, Davison sorbance again. Chemical Co., Baltimore, Md., or equiva- Transfer 50 grams of silica gel to the lent). chromatographic tube for sample analysis. Benzene, spectro grade (Burdick and Jackson Raise and drop the column on a semisoft, Laboratories, Inc., Muskegon, Mich., or equiva- clean surface for about 1 minute to settle the lent). Use 80 milliliters for the test. If nec- gel. Pour 100 milliliters of hexane into the essary, benzene may be purified by distilla- column with the stopcock open and allow to tion or otherwise. drain to about one-half inch above the gel. Hexane, spectro grade (Burdick and Jackson Laboratories, Inc., Muskegon, Mich., or equiva- Turn off the stopcock and allow the column lent). Use 650 milliliters for the test. If nec- to cool for 30 minutes. After cooling, vibrate essary, hexane may be purified by distilla- the column to eliminate air and stir the top tion or otherwise. 1 to 2 inches with a small diameter stainless 1,2-Dichloroethane, spectro grade (Matheson, steel rod. Take care not to get the gel above Coleman, and Bell, East Rutherford, N.J., or the liquid and onto the sides of the column. equivalent). Use 20 milliliters for test. If nec- Weigh out 40 grams ±0.1 gram of the hydro- essary, 1,2-dichloroethane may be purified by carbon solvent sample into a 250-milliliter distillation. beaker, add 50 milliliters of hexane, and pour Eluting mixtures: the solution into the column. Rinse the 1. 10 percent 1,2-dichloroethane in hexane. beaker with 50 milliliters of hexane and add Pipet 100 milliliters of 1,2-dichloroethane this to the column. Allow the hexane sample into a 1-liter glass-stoppered volumetric solution to elute into a 500-milliliter beaker flask and adjust to volume with hexane, with until the solution is about one-half inch mixing. above the gel. Rinse the column three times 2. 40 percent benzene in hexane. Pipet 400 with 50-milliliter portions of hexane. Allow milliliters of benzene into a 1-liter glass- each hexane rinse to separately elute to stoppered volumetric flask and adjust to vol- about one-half inch above the gel. Replace ume with hexane, with mixing. the eluate beaker (discard the hexane eluate) n-Hexadecane, 99 percent olefin-free. Dilute with a 250-milliliter beaker. Add two sepa- 1.0 milliliter of n-hexadecane to 5 milliliters rate 25-milliliter portions of 10 percent 1,2- with isooctane and determine the absorbance dichloroethane and allow each to separately in a 1-centimeter cell compared to isooctane elute as before. Finally, add 150 milliliters of as reference between 280 mμ-400mμ. The ab- 10 percent 1,2-dichloroethane for a total of sorbance per centimeter path length shall 200 milliliters. When the final 10 percent 1,2- not exceed 0.00 in this range. If necessary, n- dichloroethane fraction is about one-half hexadecane may be purified by percolation inch above the top of the gel bed, replace the through activated silica gel or by distilla- receiving beaker (discard the 1,2- tion. dichloroethane eluate) with a 250-milliliter Silica gel, 28–200 mesh (Grade 12, Davison beaker containing 1 milliliter of hexadecane. Chemical Co., Baltimore, Md., or equivalent). Adjust the elution rate to 2 to 3 milliliters Activate as follows: Weigh about 900 grams per minute, add two 25-milliliter portions of into a 1-gallon bottle, add 100 milliliters of 40 percent benzene and allow each to sepa- de-ionized water, seal the bottle and shake rately elute as before to within about one- and roll at intervals for 1 hour. Allow to half inch of the gel bed. Finally, add 150 mil- equilibrate overnight in the sealed bottle. liliters of 40 percent benzene for a total of 200 Activate the gel at 150 °C for 16 hours, in a milliliters. Evaporate the benzene in the 2-inch × 7-inch × 12-inch porcelain pan loose- oven with vacuum and sufficient nitrogen ly covered with aluminum foil, cool in a flow to just ripple the top of the benzene so- dessicator, transfer to a bottle and seal. lution. When the benzene is removed (as determined by a constant volume of hexa- PROCEDURE decane) add 5 milliliters of isooctane and Determination of ultraviolet absorbance. Be- evaporate. Repeat once to insure complete fore proceeding with the analysis of a sample removal of benzene. Remove the beaker and determine the absorbance in a 1-centimeter cover with aluminum foil (previously rinsed path cell for the reagent blank by carrying with hexane) until cool.

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Quantitatively transfer the hexadecane (b) Olestra meets the specifications residue to a 5-milliliter volumetric flask and of the Food Chemicals Codex, 7th ed. dilute to volume with isooctane. Determine (2010), pp. 744–746, which is incorporated the absorbance of the solution in 1-centi- by reference. The Director of the Office meter path length cells between 280 and 400 millimicrons using isooctane as a reference. of the Federal Register approves this Correct the absorbance values for any ab- incorporation by reference in accord- sorbance derived from reagents as deter- ance with 5 U.S.C. 552(a) and 1 CFR mined by carrying out the procedure without part 51. You may obtain copies from a sample. If the corrected absorbance does the United States Pharmacopeial Con- not exceed the limits prescribed in para- vention, 12601 Twinbrook Pkwy., Rock- graph (b)(1)(ii) of this section, the sample ville, MD 20852 (Internet address http:// meets the ultraviolet absorbance specifications for hydrocarbon solvent. www.usp.org). Copies may be examined at the Food and Drug Administration’s (c) Synthetic fatty alcohols may be Main Library, 10903 New Hampshire used as follows: Ave., Bldg. 2, Third Floor, Silver (1) As substitutes for the cor- Spring, MD 20993, 301–796–2039, or at the responding naturally derived fatty al- National Archives and Records Admin- cohols permitted in food by existing istration (NARA). For information on regulations in this part or part 173 of the availability of this material at this chapter provided that the use is in NARA, call 202–741–6030 or go to: http:// compliance with any prescribed limita- www.archives.gov/federal-register/cfr/ibr- tions. locations.html. (2) As substitutes for the cor- (c) Olestra may be used in place of responding naturally derived fatty al- fats and oils in prepackaged ready-to- cohols used as intermediates in the eat savory (i.e., salty or piquant but synthesis of food additives and other not sweet) snacks and prepackaged, substances permitted in food. unpopped popcorn kernels that are [42 FR 14491, Mar. 15, 1977, as amended at 47 ready-to-heat. In such foods, the addi- FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, tive may be used in place of fats and 1984; 54 FR 24897, June 12, 1989; 70 FR 72908, oils for frying or baking, in dough con- Dec. 8, 2005; 81 FR 5591, Feb. 3, 2016] ditioners, in sprays, in filling ingredients, or in flavors. § 172.866 Synthetic glycerin produced (d) To compensate for any inter- by the hydrogenolysis of carbo- ference with absorption of fat soluble hydrates. vitamins, the following vitamins shall Synthetic glycerin produced by the be added to foods containing olestra: hydrogenolysis of carbohydrates may 1.9 milligrams alpha-tocopherol equiva- be safely used in food, subject to the lents per gram olestra; 51 retinol provisions of this section: equivalents per gram olestra (as (a) It shall contain not in excess of retinyl acetate or retinyl palmitate); 12 0.2 percent by weight of a mixture of IU vitamin D per gram olestra; and 8 μg butanetriols. vitamin K1 per gram olestra. (b) It is used or intended for use in an (e)(1) Vitamins A, D, E, and K present amount not to exceed that reasonably in foods as a result of the requirement required to produce its intended effect. in paragraph (d) of this section shall be declared in the listing of ingredients. § 172.867 Olestra. Such vitamins shall not be considered Olestra, as identified in this section, in determining nutrient content for the may be safely used in accordance with nutritional label or for any nutrient the following conditions: claims, express or implied. (a) Olestra is a mixture of octa-, (i) An asterisk shall follow vitamins hepta-, and hexa-esters of sucrose with A, D, E, and K in the listing of ingredi- fatty acids derived from edible fats and ents; oils or fatty acid sources that are gen- (ii) The asterisk shall appear as a su- erally recognized as safe or approved perscript following each vitamin; for use as food ingredients. The chain (iii) Immediately following the ingre- lengths of the fatty acids are no less dient list an asterisk and statement, than 12 carbon atoms. ‘‘Dietarily insignificant’’ shall appear

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prominently and conspicuously as spec- (a) Sucrose oligoesters consist of ified in § 101.2(c) of this chapter; mixtures of sucrose fatty acid esters (2) Olestra shall not be considered as with an average degree of a source of fat or calories for purposes esterification ranging from four to of §§ 101.9 and 101.13 of this chapter. seven. It is produced by interesterification of sucrose with [61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, methyl esters of fatty acids derived 1996, as amended at 68 FR 46402, Aug. 5, 2003; 69 FR 29432, May 24, 2004; 78 FR 71465, Nov. 29, from edible fats and oils (including hy- 2013] drogenated fats and oils). The only solvents which may be used in the prepa- § 172.868 Ethyl cellulose. ration of sucrose oligoesters are dimethyl sulfoxide, isobutyl alcohol, and The food additive ethyl cellulose may those solvents generally recognized as be safely used in food in accordance safe in food. with the following prescribed condi- (b) Sucrose oligoesters meet the spec- tions: ifications in the methods listed in the (a) The food additive is a cellulose table in this paragraph. The methods ether containing ethoxy (OC2H5) groups for determining compliance with each attached by an ether linkage and con- specification are incorporated by ref- taining on an anhydrous basis not more erence. The Director of the Office of than 2.6 ethoxy groups per the Federal Register approves this in- anhydroglucose unit. corporation by reference in accordance (b) It is used or intended for use as with 5 U.S.C. 552(a) and 1 CFR part 51. follows: Copies may be examined at the Food (1) As a binder and filler in dry vita- and Drug Administration’s Main Li- min preparations. brary, 10903 New Hampshire Ave., Bldg. (2) As a component of protective 2, Third Floor, Silver Spring, MD 20993, coatings for vitamin and mineral tab- 301–796–2039, or at the National Ar- lets. chives and Records Administration (3) As a fixative in flavoring com- (NARA). For information on the avail- pounds. ability of this material at NARA, call 202–741–6030 or go to: http:// § 172.869 Sucrose oligoesters. www.archives.gov/federal-register/cfr/ibr- Sucrose oligoesters, as identified in locations.html. Copies of the methods this section, may be safely used in ac- are available from the sources listed in cordance with the following conditions: the table in this paragraph:

Specification Limit Method Cited Source for Obtaining Method

(1) Sucrose esters ...... Not less than 90% ...... ‘‘Method for Analyzing the Pu- Office of Food Additive Safe- rity of Sucrose Fatty Acid ty, Center for Food Safety Esters,’’ issued by and Applied Nutrition (HFS– Mitsubishi Chemical Corp., 200), Food and Drug Ad- June 17, 1998. ministration, 5001 Campus Dr., College Park, MD 20740.

(2) Mono-, di-, and tri-esters ... Not more than 45% ...... ‘‘Method for Measuring the Do. Ester Distribution of Su- crose Oligoesters,’’ issued by Mitsubishi Chemical Corp., June 17, 1998.

(3) Tetra-, penta-, hexa-, and Not less than 50% ...... Do. Do. hepta-esters.

(4) Octa-esters ...... Not more than 40% ...... Do. Do.

(5) Free Sucrose ...... Not more than 0.5% ...... ‘‘Free Sucrose Method,’’ Do. issued by Mitsubishi Chem- ical Corp., June 17, 1998.

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Specification Limit Method Cited Source for Obtaining Method

(6) Acid Value ...... Not more than 4.0 ...... ‘‘Acid Value,’’ Appendix VII, United States Pharmacopeial Method I (Commercial Fatty Convention, 12601 Acids), in the Food Chemi- Twinbrook Pkwy., Rockville, cals Codex, 7th ed. (2010), MD 20852 (Internet address p. 1220. http://www.usp.org)

(7) Residue on Ignition ...... Not more than 0.7% ...... ‘‘Residue on Ignition,’’ Appen- Do. dix IIC, Method I, in the Food Chemicals Codex, 7th ed. (2010), pp. 1141–1142 (using a 1-gram sample).

(8) Residual Methanol ...... Not more than 10 milligrams/ Method listed in the mono- Do kilogram. graph for ‘‘Sucrose Fatty Acid Esters’’ in the Food Chemicals Codex, 7th ed. (2010), pp. 998–1000.

(9) Residual Dimethyl Sulf- Not more than 2.0 milligrams/ ...... do Do. oxide. kilogram.

(10) Residual Isobutyl Alcohol Not more than 10 milligrams/ ...... do Do. kilogram.

(11) Lead ...... Not more than 1.0 milligram/ ‘‘Atomic Absorption Do. kilogram. Spectrophometric Graphite Furnace Method,’’ Method I in the Food Chemicals Codex, 7th ed. (2010), p. 1154–1155

(c) The additive is used as an emulsi- (2) A cellulose ether containing pro- fier (as defined in § 170.3(o)(8) of this pylene glycol groups attached by an chapter) or stabilizer (as defined in ether linkage having a hydroxypropoxy § 170.3(o)(28) of this chapter) in choco- (OC3H6OH) content of 5 to 16 percent late and in butter-substitute spreads, weight in weight (w/w) on an anhydrous at a level not to exceed 2.0 percent; ex- basis, i.e., 0.1 to 0.4 hydroxypropyl cept that the additive may not be used groups per anhydroglucose unit. The in a standardized food unless permitted common name for this form of the ad- by the standard of identity. ditive is low substituted hydroxypropyl cellulose. [68 FR 50072, Aug. 20, 2003, as amended at 78 FR 71465, Nov. 29, 2013] (b) The additive is used or intended for use as follows: § 172.870 Hydroxypropyl cellulose. (1) The additive identified in paragraph (a)(1) of this section is used or The food additive hydroxypropyl cel- intended for use as an emulsifier, film lulose may be safely used in food, ex- former, protective colloid, stabilizer, cept standardized foods that do not provide for such use, in accordance suspending agent, or thickener in food, with the following prescribed condi- in accordance with good manufacturing tions: practice. The additive also may be used as a binder in dietary supplements, in (a) The additive consists of one of the accordance with good manufacturing following: practice. (1) A cellulose ether containing propylene glycol groups attached by an (2) The additive identified in para- ether linkage that contains, on an an- graph (a)(2) of this section is used or hydrous basis, not more than 4.6 intended for use as a binder and dis- hydroxypropyl groups per integrator in tablets or wafers con- anhydroglucose unit. The additive has taining dietary supplements of vita- a minimum viscosity of 10 centipoises mins and/or minerals. The additive is for a 10 percent by weight aqueous solution at 25 degrees C.

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used in accordance with good manufac- tains adequate directions for use to turing practice. provide a final product that complies with the limitations prescribed in para- [46 FR 50065, Oct. 9, 1981, as amended at 76 FR 41689, July 15, 2011] graph (b) of this section. [42 FR 14491, Mar. 15, 1977, as amended at 47 § 172.872 Methyl ethyl cellulose. FR 38273, Aug. 31, 1982] The food additive methyl ethyl cellulose may be safely used in food in ac- § 172.876 Castor oil. cordance with the following prescribed The food additive castor oil may be conditions. safely used in accordance with the fol- (a) The additive is a cellulose ether lowing conditions: having the general formula (a) The additive meets the specifica- [C6H(10-x-y)O5(CH3)x(C2H5)y]n, where x is tions of the United States Pharma- the number of methyl groups and y is copeia XX (1980). the number of ethyl groups. The aver- (b) The additive is used or intended age value of x is 0.3 and the average for use as follows: value of y is 0.7. (b) The additive meets the following Use and Limitations specifications: Hard candy production—As a release agent (1) The methoxy content shall be not and antisticking agent, not to exceed 500 less than 3.5 percent and not more than parts per million in hard candy. Vitamin and mineral tablets—As a compo- 6.5 percent, calculated as OCH3, and the ethoxy content shall be not less than nent of protective coatings. 14.5 percent and not more than 19 per- [42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984] cent, calculated as OC2H5, both measured on the dry sample. (2) The viscosity of an aqueous solu- § 172.878 White mineral oil. tion, 2.5 grams of the material in 100 White mineral oil may be safely used milliliters of water, at 20 °C, is 20 to 60 in food in accordance with the fol- centipoises. lowing conditions: (3) The ash content on a dry basis has (a) White mineral oil is a mixture of a maximum of 0.6 percent. liquid hydrocarbons, essentially par- (c) The food additive is used as an affinic and naphthenic in nature ob- aerating, emulsifying, and foaming tained from petroleum. It is refined to agent, in an amount not in excess of meet the following specifications: that reasonably required to produce its (1) It meets the test requirements of intended effect. the United States Pharmacopeia XX (1980) for readily carbonizable sub- § 172.874 Hydroxypropyl stances (page 532). methylcellulose. (2) It meets the test requirements of The food additive hydroxypropyl U.S.P. XVII for sulfur compounds (page methylcellulose (CAS Reg. No. 9004–65– 400). 3) may be safely used in food, except in (3) It meets the specifications pre- standardized foods which do not pro- scribed in the ‘‘Journal of the Associa- vide for such use if: tion of Official Analytical Chemists,’’ (a) The additive complies with the Volume 45, page 66 (1962), which is in- definition and specifications prescribed corporated by reference, after correc- in the National Formulary, 12th edition of the ultraviolet absorbance for tion. any absorbance due to added anti- (b) It is used or intended for use as an oxidants. Copies of the material incor- emulsifier, film former, protective col- porated by reference are available from loid, stabilizer, suspending agent, or the Center for Food Safety and Applied thickener, in accordance with good Nutrition (HFS–200), Food and Drug manufacturing practice. Administration, 5001 Campus Dr., Col- (c) To insure safe use of the additive, lege Park, MD 20740, or available for in- the container of the additive, in addi- spection at the National Archives and tion to being labeled as required by the Records Administration (NARA). For general provisions of the act, shall be information on the availability of this accompanied by labeling which con- material at NARA, call 202–741–6030, or

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go to: http://www.archives.gov/ regulations issued in accordance with federallregister/ section 409 of the Act, in an amount codeloflfederallregulations/ not greater than that required to ibrllocations.html. produce its intended effect. (b) White mineral oil may contain (c) White mineral oil is used or in- any antioxidant permitted in food by tended for use as follows:

Limitation (inclusive of all petroleum hydro- Use carbons that may be used in combination with white mineral oil)

1. As a release agent, binder, and lubricant in or on capsules and tablets con- Not to exceed 0.6% of the capsule or tab- taining concentrates of flavoring, spices, condiments, and nutrients intended for let. addition to food, excluding confectionery. 2. As a release agent, binder, and lubricant in or on capsules and tablets con- Not to exceed 0.6% of the capsule or tab- taining food for special dietary use. let. 3. As a float on fermentation fluids in the manufacture of vinegar and wine to pre- In an amount not to exceed good manu- vent or retard access of air, evaporation, and wild yeast contamination during facturing practice. fermentation. 4. As a defoamer in food ...... In accordance with § 173.340 of this chapter. 5. In bakery products, as a release agent and lubricant ...... Not to exceed 0.15% of bakery products. 6. In dehydrated fruits and vegetables, as a release agent ...... Not to exceed 0.02% of dehydrated fruits and vegetables. 7. In egg white solids, as a release agent ...... Not to exceed 0.1% of egg white solids. 8. On raw fruits and vegetables, as a protective coating ...... In an amount not to exceed good manufacturing practice. 9. In frozen meat, as a component of hot-melt coating ...... Not to exceed 0.095% of meat. 10. As a protective float on brine used in the curing of pickles ...... In an amount not to exceed good manufacturing practice. 11. In molding starch used in the manufacture of confectionery ...... Not to exceed 0.3 percent in the molding starch. 12. As a release agent, binder, and lubricant in the manufacture of yeast ...... Not to exceed 0.15 percent of yeast. 13. As an antidusting agent in sorbic acid for food use ...... Not to exceed 0.25 percent in the sorbic acid. 14. As release agent and as sealing and polishing agent in the manufacture of Not to exceed 0.2 percent of confectionery. confectionery. 15. As a dust control agent for wheat, corn, soybean, barley, rice, rye, oats, and Applied at a level of no more than 0.02 sorghum. percent by weight of grain. 16. As a dust control agent for rice ...... ISO 100 oil viscosity (100 centistokes (cSt) at 100 °F) applied at a level of no more than 0.08 percent by weight of the rice grain.

[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 8764, Mar. 2, 1982; 47 FR 11838, Mar. 19, 1982; 48 FR 55728, Dec. 15, 1983; 49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 63 FR 66014, Dec. 1, 1998]

§ 172.880 Petrolatum. subjected to the analytical procedure described in § 172.886(b): Petrolatum may be safely used in food, subject to the provisions of this Ultraviolet absorbance per centimeter section. path length: (a) Petrolatum complies with the Millimicrons Maximum specifications set forth in the United States Pharmacopeia XX (1980) for 280–289 ...... 0.25 290–299 ...... 20 white petrolatum or in the National 300–359 ...... 14 Formulary XV (1980) for petrolatum. 360–400 ...... 04 (b) Petrolatum meets the following ultraviolet absorbance limits when (c) Petrolatum is used or intended for use as follows:

Limitation (inclusive of all petroleum hydrocarbons Use that may be used in combination with petrolatum)

In bakery products; as release agent and lubricant ...... With white mineral oil, not to exceed 0.15 percent of bakery product. In confectionery; as release agent and as sealing and polishing agent ... Not to exceed 0.2 percent of confectionery.

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Limitation (inclusive of all petroleum hydrocarbons Use that may be used in combination with petrolatum)

In dehydrated fruits and vegetables; as release agent ...... Not to exceed 0.02 percent of dehydrated fruits and vegetables. In egg white solids; as release agent ...... Not to exceed 0.1 percent of egg white solids. On raw fruits and vegetables; as protective coating ...... In an amount not to exceed good manufacturing practice. In beet sugar and yeast; as defoaming agent ...... As prescribed in § 173.340 of this chapter.

(d) Petrolatum may contain any 200), Food and Drug Administration, 5001 antioxidant permitted in food by regu- Campus Dr., College Park, MD 20740, or lations issued in accordance with sec- available for inspection at the National Ar- tion 409 of the Act, in an amount not chives and Records Administration (NARA). greater than that required to produce For information on the availability of this its intended effect. material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/ [42 FR 14491, Mar. 15, 1977, as amended at 49 codeloflfederallregulations/ FR 10105, Mar. 19, 1984] ibrllocations.html. For hydrocarbons boiling below 250 °F, the nonvolatile residue shall be § 172.882 Synthetic isoparaffinic petro- determined by ASTM method D1353–78, leum hydrocarbons. ‘‘Standard Test Method for Nonvolatile Mat- Synthetic isoparaffinic petroleum ter in Volatile Solvents for Use in Paint, hydrocarbons may be safely used in Varnish, Lacquer, and Related Products;’’ food, in accordance with the following for those boiling above 121 °C, ASTM method conditions: D381–80, ‘‘Standard Test Method for Existent (a) They are produced by synthesis Gum in Fuels by Jet Evaporation’’ shall be from petroleum gases and consist of a used. These methods are incorporated by ref- mixture of liquid hydrocarbons meet- erence. Copies may be obtained from the ing the following specifications: American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Phila- Boiling point 93–260 °C as determined by delphia, PA 19428-2959, or may be examined ASTM method D86–82, ‘‘Standard Method for at the National Archives and Records Ad- Distillation of Petroleum Products,’’ which ministration (NARA). For information on is incorporated by reference. Copies may be the availability of this material at NARA, obtained from the American Society for call 202–741–6030, or go to: http:// Testing Materials, 100 Barr Harbor Dr., West www.archives.gov/federallregister/ Conshohocken, Philadelphia, PA 19428-2959, codeloflfederallregulations/ or may be examined at the National Ar- ibrllocations.html. chives and Records Administration (NARA). For information on the availability of this (b) Isoparaffinic petroleum hydro- material at NARA, call 202–741–6030, or go to: carbons may contain antioxidants au- http://www.archives.gov/federallregister/ thorized for use in food in an amount codeloflfederallregulations/ ibrllocations.html. not to exceed that reasonably required Ultraviolet absorbance: to accomplish the intended technical 260–319 millimicrons—1.5 maximum. effect nor to exceed any prescribed lim- 320–329 millimicrons—0.08 maximum. itations. 330–350 millimicrons—0.05 maximum. Nonvolatile residual: 0.002 gram per 100 (c) Synthetic isoparaffinic petroleum milliliters maximum. hydrocarbons are used or intended for Synthetic isoparaffinic petroleum hydro- use as follows: carbons containing antioxidants shall meet the specified ultraviolet absorbance limits Uses Limitations after correction for any absorbance due to the antioxidants. The ultraviolet absorbance 1. In the froth-flotation cleaning of In an amount not to ex- shall be determined by the procedure de- vegetables. ceed good manufacturing practice. scribed for application of mineral oil, dis- 2. As a component of insecticide Do. regarding the last sentence of the procedure, formulations for use on proc- under ‘‘Specifications’’ on page 66 of the essed foods. ‘‘Journal of the Association of Official Ana- 3. As a component of coatings on Do. lytical Chemists,’’ Volume 45 (February fruits and vegetables. 1962), which is incorporated by reference. 4. As a coating on shell eggs ...... Do. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–

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Uses Limitations Use Limitations

5. As a float on fermentation Do. As a component of insecticide for- Do. fluids in the manufacture of vin- mulations used in compliance egar and wine and on brine with regulations issued in parts used in curing pickles, to pre- 170 through 189 of this chapter. vent or retard access of air, evaporation, and contamination with wild organisms during fer- § 172.886 Petroleum wax. mentation. Petroleum wax may be safely used in or on food, in accordance with the fol- [42 FR 14491, Mar. 15, 1977, as amended at 47 lowing conditions: FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, (a) Petroleum wax is a mixture of 1984; 54 FR 24897, June 12, 1989] solid hydrocarbons, paraffinic in na- § 172.884 Odorless light petroleum hy- ture, derived from petroleum, and re- drocarbons. fined to meet the specifications prescribed by this section. Odorless light petroleum hydro- (b) Petroleum wax meets the fol- carbons may be safely used in food, in lowing ultraviolet absorbance limits accordance with the following pre- when subjected to the analytical proce- scribed conditions: dure described in this paragraph. (a) The additive is a mixture of liquid hydrocarbons derived from petroleum Maximum ultraviolet or synthesized from petroleum gases. absorb- The additive is chiefly paraffinic, ance per centimeter isoparaffinic, or naphthenic in nature. path length (b) The additive meets the following specifications: 280–289 millimicrons ...... 0.15 290–299 millimicrons ...... 0.12 (1) Odor is faint and not kerosenic. 300–359 millimicrons ...... 0.08 (2) Initial boiling point is 300 °F min- 360–400 millimicrons ...... 0.02 imum. (3) Final boiling point is 650 °F max- ANALYTICAL SPECIFICATION FOR PETROLEUM imum. WAX (4) Ultraviolet absorbance limits de- GENERAL INSTRUCTIONS termined by method specified in § 178.3620(b)(1)(ii) of this chapter, as fol- Because of the sensitivity of the test, the lows: possibility of errors arising from contamination is great. It is of the greatest importance Maximum that all glassware be scrupulously cleaned to absorb- remove all organic matter such as oil, μ ance per grease, detergent residues, etc. Examine all Wavelength m centimeter optical glassware, including stoppers and stopcocks, pathlength under ultraviolet light to detect any residual fluorescent contamination. As a pre- 280–289 ...... 4.0 cautionary measure it is recommended prac- 290–299 ...... 3.3 tice to rinse all glassware with purified iso- 300–329 ...... 2.3 330–360 ...... 8 octane immediately before use. No grease is to be used on stopcocks or joints. Great care (c) The additive is used as follows: to avoid contamination of wax samples in handling and to assure absence of any extra- Use Limitations neous material arising from inadequate packaging is essential. Because some of the As a coating on shell eggs ...... In an amount not to ex- polynuclear hydrocarbons sought in this test ceed good manufac- are very susceptible to photo-oxidation, the turing practice. entire procedure is to be carried out under As a defoamer in processing beet Complying with sugar and yeast. § 173.340 of this chap- subdued light. ter. As a float on fermentation fluids in In an amount not to ex- APPARATUS the manufacture of vinegar and ceed good manufac- Separatory funnels. 250–milliliter, 500–milli- wine to prevent or retard ac- turing practice. liter, 1,000–milliliter, and preferably 2,000– cess of air, evaporation, and wild yeast contamination during milliliter capacity, equipped with tetra- fermentation. fluoroethylene polymer stopcocks. In the froth-flotation cleaning of Do. Reservoir. 500–milliliter capacity, equipped vegetables. with a 24/40 standard taper male fitting at

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the bottom and a suitable ball-joint at the Wavelength repeatability, ±0.2 milli- top for connecting to the nitrogen supply. micron. The male fitting should be equipped with Wavelength accuracy, ±1.0 millimicron. glass hooks. Nitrogen cylinder. Water-pumped or equiva- Chromatographic tube. 180 millimeters in lent purity nitrogen in cylinder equipped length, inside diameter to be 15.7 millimeters with regulator and valve to control flow at 5 ±0.1 millimeter, equipped with a coarse, frit- p.s.i.g. ted-glass disc, a tetrafluoroethylene polymer stopcock, and a female 24/40 standard tapered REAGENTS AND MATERIALS fitting at the opposite end. (Overall length of Organic solvents. All solvents used through- the column with the female joint is 235 milli- out the procedure shall meet the specifica- meters.) The female fitting should be tions and tests described in this specifica- equipped with glass hooks. tion. The isooctane, benzene, acetone, and Disc. Tetrafluoroethylene polymer 2–inch methyl alcohol designated in the list fol- diameter disc approximately 3⁄16–inch thick lowing this paragraph shall pass the fol- with a hole bored in the center to closely fit lowing test: the stem of the chromatographic tube. To the specified quantity of solvent in a Heating jacket. Conical, for 500–milliliter 250–milliliter Erlenmeyer flask, add 1 milli- separatory funnel. (Used with variable trans- liter of purified n-hexadecane and evaporate former heat control.) on the steam bath under a stream of nitro- Suction flask. 250–milliliter or 500–milliliter gen (a) loose aluminum foil jacket around filter flask. the flask will speed evaporation). Dis- Condenser. 24/40 joints, fitted with a drying continue evaporation when not over 1 milli- tube, length optional. liter of residue remains. (To the residue from Evaporation flask (optional). 250–milliliter benzene add a 10–milliliter portion of puri- or 500–milliliter capacity all-glass flask fied isooctane, reevaporate, and repeat once equipped with standard taper stopper having to insure complete removal of benzene.) inlet and outlet tubes to permit passage of Alternatively, the evaporation time can be nitrogen across the surface of contained liq- reduced by using the optional evaporation uid to be evaporated. flask. In this case the solvent and n-hexa- Vacuum distillation assembly. All glass (for decane are placed in the flask on the steam purification of dimethyl sulfoxide); 2–liter bath, the tube assembly is inserted, and a distillation flask with heating mantle; stream of nitrogen is fed through the inlet Vigreaux vacuum-jacketed condenser (or tube while the outlet tube is connected to a equivalent) about 45 centimeters in length solvent trap and vacuum line in such a way and distilling head with separable cold finger as to prevent any flow-back of condensate condenser. Use of tetrafluoroethylene poly- into the flask. mer sleeves on the glass joints will prevent Dissolve the 1 milliliter of hexadecane res- freezing. Do not use grease on stopcocks or idue in isooctane and make to 25 milliliters joints. volume. Determine the absorbance in the 5– Spectrophotometric cells. Fused quartz cells, centimeter path length cells compared to optical path length in the range of 5.000 cen- isooctane as reference. The absorbance of the timeters ±0.005 centimeter; also for checking solution of the solvent residue (except for spectrophotometer performance only, optical methyl alcohol) shall not exceed 0.01 per cen- path length in the range 1.000 centimeter timeter path length between 280 and 400 mμ. ±0.005 centimeter. With distilled water in the For methyl alcohol this absorbance value cells, determine any absorbance differences. shall be 0.00. Spectrophotometer. Spectral range 250 milli- Isooctane (2,2,4–trimethylpentane). Use 180 microns–400 millimicrons with spectral slit milliliters for the test described in the pre- width of 2 millimicrons or less, under instru- ceding paragraph. Purify, if necessary, by ment operating conditions for these absorb- passage through a column of activated silica ance measurements, the spectrophotometer gel (Grade 12, Davison Chemical Company, shall also meet the following performance Baltimore, Maryland, or equivalent) about 90 requirements: ± Absorbance repeatability, 0.01 at 0.4 ab- cular 484 is incorporated by reference. Copies sorbance. are available from the Center for Food Safe- 1 ± Absorbance accuracy, 0.05 at 0.4 absorb- ty and Applied Nutrition (HFS–200), Food ance. and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for in- 1 As determined by using potassium chro- spection at the National Archives and mate for reference standard and described in Records Administration (NARA). For infor- National Bureau of Standards Circular 484, mation on the availability of this material Spectrophotometry, U.S. Department of at NARA, call 202–741–6030, or go to: http:// Commerce, (1949). The accuracy is to be de- www.archives.gov/federallregister/ termined by comparison with the standard codeloflfederallregulations/ values at 290, 345, and 400 millimicrons. Cir- ibrllocations.html.

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centimeters in length and 5 centimeters to 8 hexadecane. Again, add 10 milliliters of iso- centimeters in diameter. octane to the residue and evaporate to 1 mil- Benzene, A.C.S. reagent grade. Use 150 milli- liliter of hexadecane to insure complete re- liters for the test. Purify, if necessary, by moval of all volatile materials. Dissolve the distillation or otherwise. 1 milliliter of hexadecane in isooctane and Acetone, A.C.S. reagent grade. Use 200 milli- make to 25–milliliter volume. Determine the liters for the test. Purify, if necessary, by reference. The absorbance of the solution distillation. should not exceed 0.02 per centimeter path Eluting mixtures: length in the 280 mμ–400 mμ range. (NOTE. 1. 10 percent benzene in isooctane. Pipet 50 Difficulty in meeting this absorbance speci- milliliters of benzene into a 500–milliliter fication may be due to organic impurities in glass-stoppered volumetric flask and adjust the distilled water. Repetition of the test to volume with isooctane, with mixing. omitting the dimethyl sulfoxide will disclose 2. 20 percent benzene in isooctane. Pipet 50 their presence. If necessary to meet the spec- milliliters of benzene into a 250–milliliter ification, purify the water by redistillation, glass-stoppered volumetric flask, and adjust passage through an ion-exchange resin, or to volume with isooctane, with mixing. otherwise.) 3. Acetone-benzene-water mixture. Add 20 Purify, if necessary, by the following pro- milliliters of water to 380 milliliters of ace- cedure: To 1,500 milliliters of dimethyl sulf- tone and 200 milliliters of benzene, and mix. oxide in a 2–liter glass-stoppered flask, add n-Hexadecane, 99 percent olefin-free. Dilute 6.0 milliliters of phosphoric acid and 50 1.0 milliliter of n-hexadecane to 25 milliliters grams of Norit A (decolorizing carbon, alka- with isooctane and determine the absorbance line) or equivalent. Stopper the flask, and in a 5–centimeter cell compared to isooctane with the use of a magnetic stirrer (tetra- as reference point between 280 mμ–400 mμ. fluoroethylene polymer coated bar) stir the The absorbance per centimeter path length solvent for 15 minutes. Filter the dimethyl shall not exceed 0.00 in this range. Purify, if sulfoxide through four thicknesses of fluted necessary, by percolation through activated paper (18.5 centimeters, Schleicher & silica gel or by distillation. Schuell, No. 597, or equivalent). If the initial Methyl alcohol, A.C.S. reagent grade. Use filtrate contains carbon fines, refilter 10.0 milliliters of methyl alcohol. Purify, if through the same filter until a clear filtrate necessary, by distillation. is obtained. Protect the sulfoxide from air Dimethyl sulfoxide. Pure grade, clear, and moisture during this operation by cov- water-white, m.p. 18° minimum. Dilute 120 ering the solvent in the funnel and collection milliliters of dimethyl sulfoxide with 240 flask with a layer of isooctane. Transfer the milliliters of distilled water in a 500–milli- filtrate to a 2–liter separatory funnel and liter separatory funnel, mix and allow to draw off the dimethyl sulfoxide into the 2– cool for 5–10 minutes. Add 40 milliliters of liter distillation flask of the vacuum dis- isooctane to the solution and extract by tillation assembly and distill at approxi- shaking the funnel vigorously for 2 minutes. mately 3–millimeter Hg pressure or less. Dis- Draw off the lower aqueous layer into a sec- card the first 200–milliliter fraction of the ond 500–milliliter separatory funnel and re- distillate and replace the distillate collec- peat the extraction with 40 milliliters of iso- tion flask with a clean one. Continue the dis- octane. Draw off and discard the aqueous tillation until approximately 1 liter of the layer. Wash each of the 40–milliliter extrac- sulfoxide has been collected. tives three times with 50–milliliter portions At completion of the distillation, the rea- of distilled water. Shaking time for each gent should be stored in glass-stoppered bot- wash is 1 minute. Discard the aqueous lay- tles since it is very hygroscopic and will ers. Filter the first extractive through anhy- react with some metal containers in the drous sodium sulfate prewashed with iso- presence of air. octane (see Sodium sulfate under ‘‘Reagents Phosphoric acid. 85 percent A.C.S. reagent and Materials’’ for preparation of filter), into grade. a 250–milliliter Erlenmeyer flask, or option- Sodium borohydride. 98 percent. ally into the evaporating flask. Wash the Magnesium oxide (Sea Sorb 43, Food Machin- first separatory funnel with the second 40– ery Company, Westvaco Division, distributed by milliliter isooctane extractive, and pass chemical supply firms, or equivalent). Place 100 through the sodium sulfate into the flask. grams of the magnesium oxide in a large Then wash the second and first separatory beaker, add 700 milliliters of distilled water funnels successively with a 10–milliliter por- to make a thin slurry, and heat on a steam tion of isooctane, and pass the solvent bath for 30 minutes with intermittent stir- through the sodium sulfate into the flask. ring. Stir well initially to insure that all the Add 1 milliliter of n-hexadecane and evapo- absorbent is completely wetted. Using a rate the isooctane on the steam bath under Buchner funnel and a filter paper (Schleicher nitrogen. Discontinue evaporation when not & Schuell No. 597, or equivalent) of suitable over 1 milliliter of residue remains. To the diameter, filter with suction. Continue suc- residue, add a 10–milliliter portion of iso- tion until water no longer drips from the octane and reevaporate to 1 milliliter of funnel. Transfer the absorbent to a glass

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trough lined with aluminum foil (free from Add 150 milliliters of isooctane and shake to rolling oil). Break up the magnesia with a preequilibrate the solvents. Draw off the in- clean spatula and spread out the absorbent dividual layers and store in glass-stoppered on the aluminum foil in a layer about 1 cen- flasks. timeter to 2 centimeters thick. Dry for 24 Place a representative 1–kilogram sample hours at 160 °C ±1 °C. Pulverize the magnesia of wax, or if this amount is not available, the with mortar and pestle. Sieve the pulverized entire sample, in a beaker of a capacity absorbent between 60–180 mesh. Use the mag- about three times the volume of the sample nesia retained on the 180–mesh sieve. and heat with occasional stirring on a steam Celite 545. Johns-Manville Company, diato- bath until the wax is completely melted and maceous earth, or equivalent. homogeneous. Weigh four 25–gram ±0.2 gram Magnesium oxide-Celite 545 mixture (2 + 1) by portions of the melted wax in separate 100– weight. Place the magnesium oxide (60–180 milliliter beakers. Reserve three of the por- mesh) and the Celite 545 in 2 to 1 proportions for later replicate analyses as nec- tions, respectively, by weight in a glass- essary. Pour one weighed portion imme- stoppered flask large enough for adequate diately after remelting (on the steam bath) mixing. Shake vigorously for 10 minutes. into a 500–milliliter separatory funnel con- Transfer the mixture to a glass trough lined taining 100 milliliters of the preequilibrated with aluminum foil (free from rolling oil) sulfoxide-phosphoric acid mixture that has and spread it out on a layer about 1 centi- been heated in the heating jacket at a tem- meter to 2 centimeters thick. Reheat the perature just high enough to keep the wax mixture at 160 °C ±1 °C for 2 hours, and store melted. (NOTE: In preheating the sulfoxide- in a tightly closed flask. acid mixture, remove the stopper of the sepa- Sodium sulfate, anhydrous, A.C.S. reagent ratory funnel at intervals to release the grade, preferably in granular form. For each pressure.) bottle of sodium sulfate reagent used, estab- Promptly complete the transfer of the lish as follows the necessary sodium sulfate sample to the funnel in the jacket with por- prewash to provide such filters required in tions of the preequilibrated isooctane, warm- the method: Place approximately 35 grams of ing the beaker, if necessary, and using a anhydrous sodium sulfate in a 30–milliliter total volume of just 50 milliliters of the sol- coarse, fritted-glass funnel or in a 65–milli- vent. If the wax comes out of solution during meter filter funnel with glass wool plug; these operations, let the stoppered funnel re- wash with successive 15–milliliter portions of main in the jacket until the wax redissolves. the indicated solvent until a 15–milliliter (Remove stopper from the funnel at intervals portion of the wash shows 0.00 absorbance to release pressure.) When the wax is in solu- per centimeter path length between 280 mμ tion, remove the funnel from the jacket and and 400 mμ when tested as prescribed under shake it vigorously for 2 minutes. Set up ‘‘Organic solvents.’’ Usually three portions three 250–milliliter separatory funnels with of wash solvent are sufficient. each containing 30 milliliters of Before proceeding with analysis of a sam- preequilibrated isooctane. After separation ple, determine the absorbance in a 5–centi- of the liquid phases, allow to cool until the meter path cell between 250 mμ and 400 mμ main portion of the wax-isooctane solution for the reagent blank by carrying out the begins to show a precipitate. Gently swirl procedure, without a wax sample, at room the funnel when precipitation first occurs on temperature, recording the spectra after the the inside surface of the funnel to accelerate extraction stage and after the complete pro- this process. Carefully draw off the lower cedure as prescribed. The absorbance per layer, filter it slowly through a thin layer of centimeter path length following the extrac- glass wool fitted loosely in a filter funnel tion stage should not exceed 0.040 in the into the first 250–milliliter separatory fun- wavelength range from 280 mμ to 400 mμ; the nel, and wash in tandem with the 30–milli- absorbance per centimeter path length fol- liter portions of isooctane contained in the lowing the complete procedure should not 250–milliliter separatory funnels. Shaking exceed 0.070 in the wavelength range from 280 time for each wash is 1 minute. Repeat the mμ to 299 mμ, inclusive, nor 0.045 in the extraction operation with two additional wavelength range from 300 mμ to 400 mμ. If in portions of the sulfoxide-acid mixture, re- either spectrum the characteristic benzene placing the funnel in the jacket after each peaks in the 250 mμ–260 mμ region are extraction to keep the wax in solution and present, remove the benzene by the proce- washing each extractive in tandem through dure under ‘‘Organic solvents’’ and record the same three portions of isooctane. absorbance again. Collect the successive extractives (300 mil- Place 300 milliliters of dimethyl sulfoxide liliters total) in a separatory funnel (pref- in a 1–liter separatory funnel and add 75 mil- erably 2–liter), containing 480 milliliters of liliters of phosphoric acid. Mix the contents distilled water, mix, and allow to cool for a of the funnel and allow to stand for 10 min- few minutes after the last extractive has utes. (The reaction between the sulfoxide been added. Add 80 milliliters of isooctane to and the acid is exothermic. Release pressure the solution and extract by shaking the fun- after mixing, then keep funnel stoppered.) nel vigorously for 2 minutes. Draw off the

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lower aqueous layer into a second separatory volume of approximately 5 milliliters. Swirl funnel (preferably 2–liter) and repeat the ex- the flask repeatedly to assure adequate traction with 80 milliliters of isooctane. washing of the sodium borohydride residues. Draw off and discard the aqueous layer. Fit the tetrafluoroethylene polymer disc Wash each of the 80–milliliter extractives on the upper part of the stem of the three times with 100–milliliter portions of chromatographic tube, then place the tube distilled water. Shaking time for each wash with the disc on the suction flask and apply is 1 minute. Discard the aqueous layers. Fil- the vacuum (approximately 135 millimeters ter the first extractive through anhydrous Hg pressure). Weight out 14 grams of the 2:1 sodium sulfate prewashed with isooctane (see magnesium oxide-Celite 545 mixture and Sodium Sulfate under ‘‘Reagents and Mate- pour the adsorbent mixture into the rials’’ for preparation of filter) into a 250– chromatographic tube in approximately 3– milliliter Erlenmeyer flask (or optionally centimeter layers. After the addition of each into the evaporation flask). Wash the first layer, level off the top of the adsorbent with separatory funnel with the second 80–milli- a flat glass rod or metal plunger by pressing liter isooctane extractive and pass through down firmly until the adsorbent is well the sodium sulfate. Then wash the second packed. Loosen the topmost few millimeters and first separatory funnels successively of each adsorbent layer with the end of a with a 20–milliliter portion of isooctane and metal rod before the addition of the next pass the solvent through the sodium sulfate layer. Continue packing in this manner until into the flask. Add 1 milliliter of n-hexa- all the 14 grams of the adsorbent is added to decane and evaporate the isooctane on the the tube. Level off the top of the adsorbent steam bath under nitrogen. Discontinue by pressing down firmly with a flat glass rod evaporation when not over 1 milliliter of res- or metal plunger to make the depth of the idue remains. To the residue, add a 10–milli- adsorbent bed approximately 12.5 centi- liter portion of isooctane, reevaporate to 1 meters in depth. Turn off the vacuum and re- milliliter of hexadecane, and repeat this op- move the suction flask. Fit the 500–milliliter eration once. reservoir onto the top of the Quantitatively transfer the residue with chromatographic column and prewet the col- isooctane to a 25–milliliter volumetric flask, umn by passing 100 milliliters of isooctane make to volume, and mix. Determine the ab- through the column. Adjust the nitrogen sorbance of the solution in the 5–centimeter pressure so that the rate of descent of the path length cells compared to isooctane as isooctane coming off of the column is be- reference between 280 mμ–400 mμ (take care tween 2–3 milliliters per minute. Discontinue to lose none of the solution in filling the pressure just before the last of the isooctane sample cell). Correct the absorbance values reaches the level of the adsorbent. (CAUTION: for any absorbance derived from reagents as Do not allow the liquid level to recede below determined by carrying out the procedure the adsorbent level at any time.) Remove the without a wax sample. If the corrected ab- reservoir and decant the 5–milliliter iso- sorbance does not exceed the limits pre- octane concentrate solution onto the column scribed in this paragraph (b), the wax meets and with slight pressure again allow the liq- the ultraviolet absorbance specifications. If uid level to recede to barely above the ad- the corrected absorbance per centimeter sorbent level. Rapidly complete the transfer path length exceeds the limits prescribed in similarly with two 5–milliliter portions of this paragraph (b), proceed as follows: isooctane, swirling the flask repeatedly each Quantitatively transfer the isooctane solu- time to assure adequate washing of the res- tion to a 125–milliliter flask equipped with idue. Just before the final 5–milliliter wash 24/40 joint and evaporate the isooctane on reaches the top of the adsorbent, add 100 mil- the steam bath under a stream of nitrogen to liliters of isooctane to the reservoir and con- a volume of 1 milliliter of hexadecane. Add tinue the percolation at the 2–3 milliliter per 10 milliliters of methyl alcohol and approxi- minute rate. Just before the last of the iso- mately 0.3 gram of sodium borohydride. octane reaches the adsorbent level, add 100 (Minimize exposure of the borohydride to the milliliters of 10 percent benzene in isooctane atmosphere. A measuring dipper may be to the reservoir and continue the percolation used.) Immediately fit a water-cooled con- at the aforementioned rate. Just before the denser equipped with a 24/40 joint and with a solvent mixture reaches adsorbent level, add drying tube into the flask, mix until the 25 milliliters of 20 percent benzene in iso- borohydride is dissolved, and allow to stand octane to the reservoir and continue the per- for 30 minutes at room temperature, with colation at 2–3 milliliters per minute until intermittent swirling. At the end of this pe- all this solvent mixture has been removed riod, disconnect the flask and evaporate the from the column. Discard all the elution sol- methyl alcohol on the steam bath under ni- vents collected up to this point. Add 300 mil- trogen until the sodium borohydride begins liliters of the acetone-benzene-water mixture to come out of the solution. Then add 10 mil- to the reservoir and percolate through the liliters of isooctane and evaporate to a vol- column to elute the polynuclear compounds. ume of about 2–3 milliliters. Again, add 10 Collect the eluate in a clean 1–liter sepa- milliliters of isooctane and concentrate to a ratory funnel. Allow the column to drain

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until most of the solvent mixture is re- for Determining Weight-Average and moved. Wash the eluate three times with Number-Average Molecular Weight and 300–milliliter portions of distilled water, for Determining Alkylacrylate Mon- shaking well for each wash. (The addition of omer Content of Poly(alkylacrylate) small amounts of sodium chloride facilitates separation.) Discard the aqueous layer after used as Processing Aid in Manufacture each wash. After the final separation, filter of Petroleum Wax,’’ which is incor- the residual benzene through anhydrous so- porated by reference in accordance dium sulfate prewashed with benzene (see So- with 5 U.S.C. 552(a) and 1 CFR part 51. dium sulfate under ‘‘Reagents and Materials’’ Copies are available from the Office of for preparation of filter) into a 250–milliliter Food Additive Safety (HFS–200), Center Erlenmeyer flask (or optionally into the for Food Safety and Applied Nutrition, evaporation flask). Wash the separatory fun- Food and Drug Administration, 5001 nel with two additional 20–milliliter portions Campus Dr., College Park, MD 20740, of benzene which are also filtered through the sodium sulfate. Add 1 milliliter of n- 240–402–1200, or may be examined at the hexadecane and completely remove the ben- Food and Drug Administration’s Main zene by evaporation under nitrogen, using Library, 10903 New Hampshire Ave., the special procedure to eliminate benzene Bldg. 2, Third Floor, Silver Spring, MD as previously described under ‘‘Organic Sol- 20993, 301–796–2039 or at the National vents.’’ Quantitatively transfer the residue Archives and Records Administration with isooctane to a 25–milliliter volumetric (NARA). For information on the avail- flask and adjust to volume. Determine the ability of this material at NARA, call absorbance of the solution in the 5–centi- 202–741–6030, or go to: http:// meter path length cells compared to isooctane as reference between 250 mμ–400 mμ. www.archives.gov/federallregister/ Correct for any absorbance derived from the codeloflfederallregulations/ reagents as determined by carrying out the ibrllocations.html. Petroleum wax shall procedure without a wax sample. If either contain not more than 1,050 parts per spectrum shows the characteristic benzene million of poly(alkylacrylate) or peaks in the 250 mμ–260 mμ region, evaporate poly(alkylmethacrylate) residues as the solution to remove benzene by the proce- determined by a method entitled dure under ‘‘Organic Solvents.’’ Dissolve the ‘‘Method for Determining Residual residue, transfer quantitatively, and adjust to volume in isooctane in a 25–milliliter vol- Level of Poly(alkylacrylate) in Petro- umetric flask. Record the absorbance again. leum Wax,’’ which is incorporated by If the corrected absorbance does not exceed reference. Copies are available from the limits prescribed in this paragraph (b), the addresses cited in this paragraph. the wax meets the ultraviolet absorbance (d) Petroleum wax is used or intended specifications. for use as follows:

(c) Petroleum wax may contain one Use Limitations or more of the following adjuvants in amounts not greater than that re- In chewing gum base, as a mas- In an amount not to ex- ticatory substance. ceed good manufac- quired to produce their intended effect: turing practice. (1) Antioxidants permitted in food by On cheese and raw fruits and Do. regulations issued in accordance with vegetables as a protective coat- section 409 of the act. ing. As a defoamer in food ...... In accordance with (2) Poly(alkylacrylate) (CAS Reg. No. § 173.340 of this chap- 27029–57–8), made from long chain (C16- ter. C ) alcohols and acrylic acid, or As a component of microcapsules In accordance with 22 for spice-flavoring substances. § 172.230 of this chap- poly(alkylmethacrylate) (CAS Reg. No. ter. 179529–36–3), made from long chain (C18- C ) methacrylate esters, having: 22 [42 FR 14491, Mar. 15, 1977, as amended at 45 (i) A number average molecular FR 48123, July 18, 1980; 47 FR 11838, Mar. 19, weight between 40,000 and 100,000; 1982; 50 FR 32561, Aug. 13, 1985; 51 FR 19544, (ii) A weight average molecular May 30, 1986; 54 FR 24897, June 12, 1989; 64 FR weight (MWw) to number average mo- 44122, Aug. 13, 1999; 78 FR 14665, Mar. 7, 2013; lecular weight (MWn) ratio (MWw/MWn) 81 FR 5592, Feb. 3, 2016] of not less than 3; and (iii) Unreacted alkylacrylate or § 172.888 Synthetic petroleum wax. alkylmethacrylate monomer content Synthetic petroleum wax may be not in excess of 14 percent, as deter- safely used in or on foods in accordance mined by a method entitled ‘‘Method with the following conditions:

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(a) Synthetic petroleum wax is a § 172.892 Food starch-modified. mixture of solid hydrocarbons, par- Food starch-modified as described in affinic in nature, prepared by either catalytic polymerization of ethylene or this section may be safely used in food. copolymerization of ethylene with lin- The quantity of any substance employed to effect such modification shall ear (C3 to C12) alpha-olefins, and refined to meet the specifications prescribed in not exceed the amount reasonably re- this section. quired to accomplish the intended (b) Synthetic petroleum wax meets physical or technical effect, nor exceed the ultraviolet absorbance limits of any limitation prescribed. To insure § 172.886(b) when subjected to the ana- safe use of the food starch-modified, lytical procedure described therein. the label of the food additive container (c) Synthetic petroleum wax has a shall bear the name of the additive number average molecular weight of ‘‘food starch-modified’’ in addition to not less than 500 nor greater than 1,200 other information required by the Act. as determined by vapor pressure os- Food starch may be modified by treat- mometry. ment prescribed as follows: (d) Synthetic petroleum wax may (a) Food starch may be acid-modified contain any antioxidant permitted in by treatment with hydrochloric acid or food by regulations issued in accord- sulfuric acid or both. ance with section 409 of the act, in an (b) Food starch may be bleached by amount not greater than that required treatment with one or more of the fol- to produce its intended effect. lowing: (e) Synthetic petroleum wax is used or intended for use as follows: Limitations Active oxygen obtained from hy- Use Limitations drogen peroxide and/or per- In chewing gum base, as a In accordance with § 172.615 acetic acid, not to exceed 0.45 masticatory substance. in an amount not to exceed percent of active oxygen. good manufacturing prac- Ammonium persulfate, not to ex- tice. ceed 0.075 percent and sulfur On cheese and raw fruits and In an amount not to exceed dioxide, not to exceed 0.05 per- vegetables as a protective good manufacturing prac- cent. coating. tice. Chlorine, as calcium hypochlorite, The finished food starch- As a defoamer in food ...... In accordance with § 173.340 not to exceed 0.036 percent of modified is limited to of this chapter. dry starch. use only as a component of batter for com- mercially processed [42 FR 14491, Mar. 15, 1977, as amended at 59 foods. FR 10986, Mar. 9, 1994] Chlorine, as sodium hypochlorite, not to exceed 0.0082 pound of § 172.890 Rice bran wax. chlorine per pound of dry starch. Potassium permanganate, not to Residual manganese Rice bran wax may be safely used in exceed 0.2 percent. (calculated as Mn), not food in accordance with the following to exceed 50 parts per million in food starch- conditions: modified. (a) It is the refined wax obtained Sodium chlorite, not to exceed 0.5 from rice bran and meets the following percent. specifications: (c) Food starch may be oxidized by Melting point 75 °C to 80 °C. Free fatty acids, maximum 10 percent. treatment with chlorine, as sodium hy- Iodine number, maximum 20. pochlorite, not to exceed 0.055 pound of Saponification number 75 to 120. chlorine per pound of dry starch. (d) Food starch may be esterified by (b) It is used or intended for use as treatment with one of the following: follows: Limitations Food Limitation in food Use Acetic anhydride ...... Acetyl groups in food Candy ...... 50 p.p.m ...... Coating. starch-modified not to Fresh fruits and fresh ...... do ...... Do. exceed 2.5 percent. vegetables. Adipic anhydride, not to exceed Do. Chewing gum ...... 21⁄2 pct ...... Plasticizing material. 0.12 percent, and acetic anhydride.

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Limitations Limitations

Monosodium orthophosphate ...... Residual phosphate in Epichlorohydrin, not to exceed 0.3 Acetyl groups in food food starch-modified percent, and acetic anhydride. starch-modified not to not to exceed 0.4 per- exceed 2.5 percent. cent calculated as Epichlorohydrin, not to exceed 0.3 phosphorus. percent, and succinic anhy- 1–Octenyl succinic anhydride, not dride, not to exceed 4 percent. to exceed 3 percent. Phosphorus oxychloride, not to Residual propylene 1–Octenyl succinic anhydride, not exceed 0.1 percent, and pro- chlorohydrin not more to exceed 2 percent, and alu- pylene oxide, not to exceed 10 than 5 parts per million minum sulfate, not to exceed 2 percent. in food starch-modi- percent. fied. 1-Octenyl succinic anhydride, not Limited to use as a sta- to exceed 3 percent, followed bilizer or emulsifier in (g) Food starch may be modified by by treatment with a beta-amy- beverages and bev- treatment with one of the following: lase enzyme that is either an erage bases as de- approved food additive of is fined in § 170.3(n)(3) of Limitations generally recognized as safe. this chapter. Phosphorus oxychloride, not to Chlorine, as sodium hypochlorite, Residual propylene exceed 0.1 percent. not to exceed 0.055 pound of chlorohydrin not more Phosphorus oxychloride, not to Acetyl groups in food chlorine per pound of dry than 5 parts per million exceed 0.1 percent, followed by starch-modified not to starch; 0.45 percent of active in food starch-modi- either acetic anhydride, not to exceed 2.5 percent. oxygen obtained from hydrogen fied. exceed 8 percent, or vinyl ace- peroxide; and propylene oxide, tate, not to exceed 7.5 percent. not to exceed 25 percent. Sodium trimetaphosphate ...... Residual phosphate in Sodium hydroxide, not to exceed food starch-modified 1 percent. not to exceed 0.04 percent, calculated as phosphorus. (h) Food starch may be modified by a Sodium tripolyphosphate and so- Residual phosphate in combination of the treatments pre- dium trimetaphosphate. food starch-modified scribed by paragraphs (a), (b), and/or (i) not to exceed 0.4 per- of this section and any one of the cent calculated as phosphorus. treatments prescribed by paragraph (c), Succinic anhydride, not to exceed (d), (e), (f), or (g) of this section, sub- 4 percent. ject to any limitations prescribed by Vinyl acetate ...... Acetyl groups in food the paragraphs named. starch-modified not to exceed 2.5 percent. (i) Food starch may be modified by treatment with the following enzymes:

(e) Food starch may be etherified by Enzyme Limitations treatment with one of the following: Alpha-amylase (E.C. 3.2.1.1) ...... The enzyme must be Limitations generally recognized as safe or approved as Acrolein, not to exceed 0.6 per- a food additive for this cent. purpose. The resulting Epichlorohydrin, not to exceed nonsweet nutritive sac- 0.3 percent. charide polymer has a Epichlorohydrin, not to exceed Residual propylene dextrose equivalent of 0.1 percent, and propylene chlorohydrin not more less than 20. oxide, not to exceed 10 per- than 5 parts per million Beta-amylase (E.C. 3.2.1.2). cent, added in combination or in food starch-modified. Glucoamylase (E.C. 3.2.1.3). in any sequence. Isoamylase (E.C. 3.2.1.68). Epichlorohydrin, not to exceed Do. Pullulanase (E.C. 3.2.1.41). 0.1 percent, followed by propylene oxide, not to exceed 25 percent. [42 FR 14491, Mar. 15, 1977, as amended at 43 Propylene oxide, not to exceed Do. FR 11697, Mar. 21, 1978; 46 FR 32015, June 19, 25 percent. 1981; 57 FR 54700, Nov. 20, 1992; 58 FR 21100, Apr. 19, 1993; 66 FR 17509, Apr. 2, 2001] (f) Food starch may be esterified and etherified by treatment with one of the § 172.894 Modified cottonseed products intended for human consumption. following: The food additive modified cotton- Limitations seed products may be used for human consumption in accordance with the Acrolein, not to exceed 0.6 per- Acetyl groups in food cent and vinyl acetate, not to starch-modified not to following prescribed conditions: exceed 7.5 percent. exceed 2.5 percent. (a) The additive is derived from:

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(1) Decorticated, partially defatted, safely used in food provided the total cooked, ground cottonseed kernels; or folic acid content of the yeast does not (2) Decorticated, ground cottonseed exceed 0.04 milligram per gram of yeast kernels, in a process that utilizes n- (approximately 0.008 milligram of hexane as an extracting solvent in such pteroyglutamic acid per gram of a way that no more than 60 parts per yeast). million of n-hexane residues and less than 1 percent fat by weight remain in § 172.898 Bakers yeast glycan. the finished product; or Bakers yeast glycan may be safely (3) Glandless cottonseed kernels used in food in accordance with the fol- roasted to attain a temperature of not lowing conditions: less than 250 °F in the kernel for not (a) Bakers yeast glycan is the less than 5 minutes for use as a snack comminuted, washed, pasteurized, and food, or in baked goods, or in soft dried cell walls of the yeast, Saccharo- candy; or myces cerevisiae. It is composed prin- (4) Raw glandless cottonseed kernels cipally of long chain carbohydrates, may be used in hard candy where the not less than 85 percent on a dry solids kernel temperature during cooking basis. The carbohydrate is composed of will exceed 250 °F for not less than 5 glycan and mannan units in approxi- minutes. mately a 2:1 ratio. (b) The additive is prepared to meet (b) The additive meets the following the following specifications: specifications on a dry weight basis: (1) Free gossypol content not to ex- Less than 0.4 part per million (ppm) ar- ceed 450 parts per million. senic, 0.13 ppm cadmium, 0.2 ppm lead, (2) It contains no added arsenic com- 0.05 ppm mercury, 0.09 ppm selenium, pound and therefore may not exceed a and 10 ppm zinc. maximum natural background level of (c) The viable microbial content of 0.2 part per million total arsenic, cal- the finished ingredient is: culated as As. (1) Less than 10,000 organisms/gram (c) To assure safe use of the additive, by aerobic plate count. the label of the food additive container (2) Less than 10 yeasts and molds/ shall bear, in addition to other infor- gram. mation required by the act, the name (3) Negative for Salmonella, E. coli, of the additive as follows: coagulase positive Staphylococci, Clos- (1) The additive identified in para- tridium perfringens, Clostridium botu- graph (a)(1) of this section as ‘‘par- linum, or any other recognized micro- tially defatted, cooked cottonseed bial pathogen or any harmful microbial flour’’. toxin. (2) The additive identified in para- (d) The additive is used or intended graph (a)(2) of this section as ‘‘defatted for use in the following foods when cottonseed flour’’. standards of identity established under (3) The additive identified in para- section 401 of the Act do not preclude graph (a)(3) of this section as ‘‘roasted such use: glandless cottonseed kernels’’. (4) The additive identified in para- Use Limitations graph (a)(4) of this section as ‘‘raw (1) In salad dressings as an emul- Not to exceed a con- glandless cottonseed kernels for use in sifier and emulsifier salt as de- centration of 5 percent fined in § 170.3(o)(8) of this of the finished salad cooked hard candy’’. chapter, stabilizer and thickener dressing. (d) The Food and Drug Administra- as defined in § 170.3(o)(28) of tion and the Environmental Protection this chapter, or texturizer as de- Agency have determined that glandless fined in § 170.3(o)(32) of this chapter. cottonseed kernels permitted for use (2) In frozen dessert analogs as a In an amount not to ex- by this section are a distinct com- stabilizer and thickener as de- ceed good manufac- modity from glanded cottonseed. fined in § 170.3(o)(28) of this turing practice. chapter, or texturizer as defined in § 170.3(o)(32) of this chapter. § 172.896 Dried yeasts. (3) In sour cream analogs as a Do. Dried yeast (Saccharomyces cerevisiae stabilizer and thickener as defined in § 170.3(o)(28) of this and Saccharomyces fragilis) and dried chapter, or texturizer as defined torula yeast (Candida utilis) may be in § 170.3(o)(32) of this chapter.

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Use Limitations 173.150 Milk-clotting enzymes, microbial. 173.160 Candida guilliermondii. (4) In cheese spread analogs as Do. 173.165 Candida lipolytica. a stabilizer and thickener as de- ′ fined in § 170.3(o)(28) of this 173.170 Aminoglycoside 3 - chapter, or texturizer as defined phosphotransferase II. in § 170.3(o)(32) of this chapter. (5) In cheese-flavored and sour Do. Subpart C—Solvents, Lubricants, Release cream-flavored snack dips as a stabilizer and thickener as de- Agents and Related Substances fined in § 170.3(o)(28) of this chapter, or texturizer as defined 173.210 Acetone. in § 170.3(o)(32) of this chapter. 173.220 1,3-Butylene glycol. 173.228 Ethyl acetate. (e) The label and labeling of the in- 173.230 Ethylene dichloride. gredient shall bear adequate directions 173.240 Isopropyl alcohol. to assure that use of the ingredient 173.250 Methyl alcohol residues. complies with this regulation. 173.255 Methylene chloride. 173.270 Hexane. [42 FR 14491, Mar. 15, 1977, as amended at 45 173.275 Hydrogenated sperm oil. FR 58836, Sept. 5, 1980] 173.280 Solvent extraction process for citric acid. PART 173—SECONDARY DIRECT 173.290 Trichloroethylene. FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMP- Subpart D—Specific Usage Additives TION 173.300 Chlorine dioxide. 173.310 Boiler water additives. Subpart A—Polymer Substances and 173.315 Chemicals used in washing or to as- Polymer Adjuvants for Food Treatment sist in the peeling of fruits and vegeta- Sec. bles. 173.5 Acrylate-acrylamide resins. 173.320 Chemicals for controlling micro- 173.10 Modified polyacrylamide resin. organisms in cane-sugar and beet-sugar 173.20 Ion-exchange membranes. mills. 173.21 Perfluorinated ion exchange mem- 173.322 Chemicals used in delinting cotton- branes. seed. 173.25 Ion-exchange resins. 173.325 Acidified sodium chlorite solutions. 173.40 Molecular sieve resins. 173.340 Defoaming agents. 173.45 Polymaleic acid and its sodium salt. 173.342 Chlorofluorocarbon 113 and 173.50 Polyvinylpolypyrrolidone. perfluorohexane. 173.55 Polyvinylpyrrolidone. 173.60 Dimethylamine-epichlorohydrin co- 173.345 Chloropentafluoroethane. polymer. 173.350 Combustion product gas. 173.65 Divinylbenzene copolymer. 173.355 Dichlorodifluoromethane. 173.70 Chloromethylated aminated styrene- 173.356 Hydrogen peroxide. divinylbenzene resin. 173.357 Materials used as fixing agents in 173.73 Sodium polyacrylate. the immobilization of enzyme prepara- 173.75 Sorbitan monooleate. tions. 173.360 Octafluorocyclobutane. Subpart B—Enzyme Preparations and 173.368 Ozone. Microorganisms 173.370 Peroxyacids. 173.110 Amyloglucosidase derived from 173.375 Cetylpyridinium chloride. Rhizopus niveus. 173.385 Sodium methyl sulfate. 173.115 Alpha-acetolactate decarboxylase (a- 173.395 Trifluoromethane sulfonic acid. ALDC) enzyme preparation derived from 173.400 Dimethyldialkylammonium chlo- a recombinant Bacillus subtilis. ride. 173.120 Carbohydrase and cellulase derived 173.405 Sodium dodecylbenzenesulfonate. from Aspergillus niger. 173.130 Carbohydrase derived from Rhizopus AUTHORITY: 21 U.S.C. 321, 342, 348. oryzae. SOURCE: 42 FR 14526, Mar. 15, 1977, unless 173.135 Catalase derived from Microccocus otherwise noted. lysodeikticus. 173.140 Esterase-lipase derived from Mucor EDITORIAL NOTE: Nomenclature changes to miehei. part 173 appear at 61 FR 14482, Apr. 2, 1996, 66 173.145 Alpha-Galactosidase derived from FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, Mortierella vinaceae var. raffinoseutilizer. 2001, and 81 FR 49896, July 29, 2016.

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