30 Part 172—Food Additives

Home , Anticaking agent, Benzyl acetate, Cinnamyl acetate, Dicarbonate, Dimethyl dicarbonate, Dioxolane

Pt. 172 21 CFR Ch. I (4–1–12 Edition)

shall be furnished in the form specified Subpart D—Special Dietary and Nutritional in §§ 171.1 and 171.100 for submitting pe- Additives titions. 172.310 Aluminum nicotinate. [42 FR 14491, Mar. 15, 1977, as amended at 42 172.315 Nicotinamide-ascorbic acid complex. FR 15674, Mar. 22, 1977] 172.320 Amino acids. 172.325 Bakers yeast protein. 172.330 Calcium pantothenate, calcium chlo- PART 172—FOOD ADDITIVES PER- ride double salt. MITTED FOR DIRECT ADDITION TO 172.335 D-Pantothenamide. FOOD FOR HUMAN CONSUMP- 172.340 Fish protein isolate. 172.345 Folic acid (folacin). TION 172.350 Fumaric acid and salts of fumaric acid. Subpart A—General Provisions 172.365 Kelp. 172.370 Iron-choline citrate complex. Sec. 172.372 N-Acetyl-L-methionine. 172.5 General provisions for direct food ad- 172.375 Potassium iodide. ditives. 172.379 Vitamin D2. 172.380 Vitamin D3. Subpart B—Food Preservatives 172.385 Whole fish protein concentrate. 172.395 Xylitol. 172.105 Anoxomer. 172.399 Zinc methionine sulfate. 172.110 BHA. 172.115 BHT. Subpart E—Anticaking Agents 172.120 Calcium disodium EDTA. 172.410 Calcium silicate. 172.130 Dehydroacetic acid. 172.430 Iron ammonium citrate. 172.133 Dimethyl dicarbonate. 172.480 Silicon dioxide. 172.135 Disodium EDTA. 172.490 Yellow prussiate of soda. 172.140 Ethoxyquin. 172.145 Heptylparaben. Subpart F—Flavoring Agents and Related 172.150 4-Hydroxymethyl-2,6-di-tert-butyl- Substances phenol. 172.510 Natural flavoring substances and 172.155 Natamycin (pimaricin). natural substances used in conjunction 172.160 Potassium nitrate. with flavors. 172.165 Quaternary ammonium chloride 172.515 Synthetic flavoring substances and combination. adjuvants. 172.167 Silver nitrate and hydrogen peroxide 172.520 Cocoa with dioctyl sodium sulfo- solution. succinate for manufacturing. 172.170 Sodium nitrate. 172.530 Disodium guanylate. 172.175 Sodium nitrite. 172.535 Disodium inosinate. 172.177 Sodium nitrite used in processing 172.540 DL-Alanine. smoked chub. 172.560 Modified hop extract. 172.180 Stannous chloride. 172.575 Quinine. 172.185 TBHQ. 172.580 Safrole-free extract of sassafras. 172.585 Sugar beet extract flavor base. 172.190 THBP. 172.590 Yeast-malt sprout extract.

Subpart C—Coatings, Films and Related Subpart G—Gums, Chewing Gum Bases Substances and Related Substances 172.210 Coatings on fresh citrus fruit. 172.610 Arabinogalactan. 172.215 Coumarone-indene resin. 172.615 Chewing gum base. 172.225 Methyl and ethyl esters of fatty 172.620 Carrageenan. acids produced from edible fats and oils. 172.623 Carrageenan with polysorbate 80. 172.230 Microcapsules for flavoring sub- 172.626 Salts of carrageenan. stances. 172.655 Furcelleran. 172.235 Morpholine. 172.660 Salts of furcelleran. 172.250 Petroleum naphtha. 172.665 Gellan gum. 172.255 Polyacrylamide. 172.695 Xanthan gum. 172.260 Oxidized polyethylene. Subpart H—Other Specific Usage Additives 172.270 Sulfated butyl oleate. 172.275 Synthetic paraffin and succinic de- 172.710 Adjuvants for pesticide use dilu- rivatives. tions. 172.280 Terpene resin. 172.712 1,3–Butylene glycol.

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172.715 Calcium lignosulfonate. 172.863 Salts of fatty acids. 172.720 Calcium lactobionate. 172.864 Synthetic fatty alcohols. 172.723 Epoxidized soybean oil. 172.866 Synthetic glycerin produced by the 172.725 Gibberellic acid and its potassium hydrogenolysis of carbohydrates. salt. 172.867 Olestra. 172.730 Potassium bromate. 172.868 Ethyl cellulose. 172.735 Glycerol ester of rosin. 172.869 Sucrose oligoesters. 172.736 Glycerides and polyglycides of hy- 172.870 Hydroxypropyl cellulose. drogenated vegetable oils. 172.872 Methyl ethyl cellulose. 172.755 Stearyl monoglyceridyl citrate. 172.874 Hydroxypropyl methylcellulose. 172.765 Succistearin (stearoyl propylene gly- 172.876 Castor oil. col hydrogen succinate). 172.878 White mineral oil. 172.770 Ethylene oxide polymer. 172.880 Petrolatum. 172.775 Methacrylic acid-divinylbenzene co- 172.882 Synthetic isoparaffinic petroleum polymer. hydrocarbons. 172.780 Acacia (gum arabic). 172.884 Odorless light petroleum hydro- 172.785 Listeria-specific bacteriophage prepa- carbons. ration. 172.886 Petroleum wax. Subpart I—Multipurpose Additives 172.888 Synthetic petroleum wax. 172.890 Rice bran wax. 172.800 Acesulfame potassium. 172.892 Food starch-modified. 172.802 Acetone peroxides. 172.894 Modified cottonseed products in- 172.804 Aspartame. tended for human consumption. 172.806 Azodicarbonamide. 172.896 Dried yeasts. 172.808 Copolymer condensates of ethylene 172.898 Bakers yeast glycan. oxide and propylene oxide. AUTHORITY: 21 U.S.C. 321, 341, 342, 348, 371, 172.809 Curdlan. 172.810 Dioctyl sodium sulfosuccinate. 379e. 172.811 Glyceryl tristearate. SOURCE: 42 FR 14491, Mar. 15, 1977, unless 172.812 Glycine. otherwise noted. 172.814 Hydroxylated lecithin. 172.816 Methyl glucoside-coconut oil ester. EDITORIAL NOTE: Nomenclature changes to 172.818 Oxystearin. part 172 appear at 61 FR 14482, Apr. 2, 1996, 66 172.820 Polyethylene gylcol (mean molec- FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, ular weight 200–9,500). 2001, 68 FR 15355, Mar. 31, 2003, 70 FR 40880, 172.822 Sodium lauryl sulfate. July 15, 2005, 70 FR 67651, Nov. 8, 2005, and 70 172.824 Sodium mono- and dimethyl naph- FR 72074, Dec. 1, 2005. thalene sulfonates. 172.826 Sodium stearyl fumarate. Subpart A—General Provisions 172.828 Acetylated monoglycerides. 172.829 Neotame. § 172.5 General provisions for direct 172.830 Succinylated monoglycerides. food additives. 172.831 Sucralose. 172.832 Monoglyceride citrate. (a) Regulations prescribing condi- 172.833 Sucrose acetate isobutyrate (SAIB). tions under which food additive sub- 172.834 Ethoxylated mono- and diglycerides. stances may be safely used predicate 172.836 Polysorbate 60. usage under conditions of good manu- 172.838 Polysorbate 65. 172.840 Polysorbate 80. facturing practice. For the purposes of 172.841 Polydextrose. this part, good manufacturing practice 172.842 Sorbitan monostearate. shall be defined to include the fol- 172.844 Calcium stearoyl-2-lactylate. lowing restrictions. 172.846 Sodium stearoyl lactylate. (1) The quantity of the substance 172.848 Lactylic esters of fatty acids. added to food does not exceed the 172.850 Lactylated fatty acid esters of glyc- amount reasonably required to accom- erol and propylene glycol. 172.852 Glyceryl-lacto esters of fatty acids. plish its intended physical, nutritive, 172.854 Polyglycerol esters of fatty acids. or other technical effect in food. 172.856 Propylene glycol mono- and diesters (2) Any substance intended for use in of fats and fatty acids. or on food is of appropriate food grade 172.858 Propylene glycol alginate. and is prepared and handled as a food 172.859 Sucrose fatty acid esters. ingredient. 172.860 Fatty acids. 172.861 Cocoa butter substitute from coco- (b) The existence of a regulation pre- nut oil, palm kernel oil, or both oils. scribing safe conditions of use for a 172.862 Oleic acid derived from tall oil fatty food additive shall not be construed to acids. relieve the use of the substance from

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compliance with any other provision of www.archives.gov/federallregister/ the Act. codeloflfederallregulations/ (c) The existence of any regulation ibrllocations.html. prescribing safe conditions of use for a (3) Phenol content: Not less than 3.2 nutrient substance does not constitute milliequivalent/gram and not more a finding that the substance is useful than 3.8 milliequivalent/gram as deter- or required as a supplement to the diet mined by a method entitled ‘‘Total of humans. Phenols,’’ 1982, which is incorporated by reference. Copies are available from Subpart B—Food Preservatives the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug § 172.105 Anoxomer. Administration, 5100 Paint Branch Anoxomer as identified in this sec- Pkwy., College Park, MD 20740, or at tion may be safely used in accordance the National Archives and Records Ad- with the following conditions: ministration (NARA). For information (a) Anoxomer is 1,4-benzenediol, 2- on the availability of this material at (1,1-dimethylethyl)-polymer with NARA, call 202–741–6030, or go to: http:// diethenylbenzene, 4-(1,1-dimethyl- www.archives.gov/federallregister/ ethyl)phenol, 4- methoxyphenol, 4,4′-(1- codeloflfederallregulations/ methylethylidene)bis(phenol) and 4- ibrllocations.html. methylphenol (CAS Reg. No. 60837–57–2) (4) Heavy metals as lead (as Pb), not prepared by condensation polymeriza- more than 10 parts per million. Arsenic tion of divinylbenzene (m- and p-) with (as As), not more than 3 parts per mil- tert-butylhydroquinone, tert-butyl- lion. Mercury (as Hg), not more than 1 phenol, hydroxyanisole, p-cresol and part per million. 4,4′-isopropylidenediphenol. (c) Anoxomer may be safely used as (b) The polymeric antioxidant meets an antioxidant in food at a level of not the following specifications: more than 5,000 parts per million based (1) Polymer, not less than 98.0 per- on fat and oil content of the food. cent as determined by an ultraviolet [48 FR 18798, Apr. 26, 1983, as amended at 54 method entitled ‘‘Ultraviolet Assay, FR 24896, June 12, 1989] ‘‘1982, which is incorporated by reference. Copies are available from the § 172.110 BHA. Center for Food Safety and Applied Nu- The food additive BHA (butylated hy- trition (HFS–200), Food and Drug Ad- droxyanisole) alone or in combination ministration, 5100 Paint Branch Pkwy., with other antioxidants permitted in College Park, MD 20740, or at the Na- food for human consumption in this tional Archives and Records Adminis- subpart B may be safely used in or on tration (NARA). For information on specified foods, as follows: the availability of this material at (a) The BHA meets the following NARA, call 202–741–6030, or go to: http:// specification: www.archives.gov/federallregister/ codeloflfederallregulations/ Assay (total BHA), 98.5 percent minimum. ibrllocations.html. Melting point 48 °C minimum. (2) Molecular weight: Total mono- (b) The BHA is used alone or in com- mers, dimers and trimers below 500 not bination with BHT, as an antioxidant more than 1 percent as determined by a in foods, as follows: method entitled ‘‘Low Molecular Weight Anoxomer Analysis,’’ 1982, Limitations (total BHA which is incorporated by reference. Food and BHT) Copies are available from the Center parts per million for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra- Dehydrated potato shreds ...... 50 tion, 5100 Paint Branch Pkwy., College Active dry yeast ...... 1 1,000 Beverages and desserts prepared from dry Park, MD 20740, or at the National Ar- mixes ...... 1 2 chives and Records Administration Dry breakfast cereals ...... 50 (NARA). For information on the avail- Dry diced glazed fruit ...... 1 32 Dry mixes for beverages and desserts ...... 1 90 ability of this material at NARA, call Emulsion stabilizers for shortenings ...... 200 202–741–6030, or go to: http:// Potato flakes ...... 50

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Limitations § 172.120 Calcium disodium EDTA. (total BHA Food and BHT) The food additive calcium disodium parts per million EDTA (calcium disodium ethylenediaminetetraacetate) may be safely Potato granules ...... 10 used in designated foods for the pur- Sweet potato flakes ...... 50 poses and in accordance with the condi- 1 BHA only. tions prescribed, as follows: (c) To assure safe use of the additive: (a) The additive contains a minimum (1) The label of any market package of 99 percent by weight of either the di- of the additive shall bear, in addition hydrate C10H12O8N2CaNa2·2H2O or the to the other information required by trihydrate C10H12O8N2CaNa2·3H2O, or the Act, the name of the additive. any mixture of the two. (2) When the additive is marketed in (b) It is used or intended for use as a suitable carrier, in addition to meet- follows: ing the requirement of paragraph (c)(1) (1) Alone, in the following foods at of this section, the label shall declare not to exceed the levels prescribed, cal- the percentage of the additive in the culated as the anhydrous compound: mixture. Limita- (3) The label or labeling of dry mixes tion for beverages and desserts shall bear Food (parts Use per mil- adequate directions for use to provide lion) that beverages and desserts prepared from the dry mixes contain no more Cabbage, pickled ...... 220 Promote color, flavor, and texture retention. than 2 parts per million BHA. Canned carbonated soft 33 Promote flavor reten- drinks. tion. § 172.115 BHT. Canned white potatoes 110 Promote color retention. Clams (cooked canned) 340 Promote color retention. The food additive BHT (butylated hy- Crabmeat (cooked 275 Retard struvite forma- droxytoluene), alone or in combination canned). tion; promote color with other antioxidants permitted in retention. this subpart B may be safely used in or Cucumbers pickled ...... 220 Promote color, flavor, and texture retention. on specified foods, as follows: Distilled alcoholic bev- 25 Promote stability of (a) The BHT meets the following erages. color, flavor, and/or specification: Assay (total BHT) 99 per- product clarity. Dressings, nonstandard- 75 Preservative. cent minimum. ized. (b) The BHT is used alone or in com- Dried lima beans 310 Promote color retention. bination with BHA, as an antioxidant (cooked canned). in foods, as follows: Egg product that is 1 200 Preservative. hard-cooked and con- Limitations sists, in a cylindrical (total BHA shape, of egg white Food and BHT) with an inner core of parts per egg yolk. million Fermented malt bev- 25 Antigushing agent. erages. Dehydrated potato shreds ...... 50 French dressing ...... 75 Preservative. Dry breakfast cereals ...... 50 Legumes (all cooked 365 Promote color retention. Emulsion stabilizers for shortenings ...... 200 canned, other than Potato flakes ...... 50 dried lima beans, pink Potato granules ...... 10 beans, and red Sweetpotato flakes ...... 50 beans). Mayonnaise ...... 75 Do. (c) To assure safe use of the additive: Mushrooms (cooked 200 Promote color retention. (1) The label of any market package canned). Oleomargarine ...... 75 Preservative. of the additive shall bear, in addition Pecan pie filling ...... 100 Promote color retention. to the other information required by Pink beans (cooked 165 Promote color retention. the Act, the name of the additive. canned). (2) When the additive is marketed in Potato salad ...... 100 Preservative. Processed dry pinto 800 Promote color retention. a suitable carrier, in addition to meet- beans. ing the requirement of paragraph (c)(1) Red beans (cooked 165 Promote color retention. of this section, the label shall declare canned). Salad dressing ...... 75 Preservative. the percentage of the additive in the Sandwich spread ...... 100 Do. mixture. Sauces ...... 75 Do.

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Limita- Sodium salt of dehydroacetic acid: Assay, tion minimum 98 percent (dry basis). Food (parts Use per mil- (b) It is used or intended for use as a lion) preservative for cut or peeled squash, Shrimp (cooked 250 Retard struvite forma- and is so used that no more than 65 canned). tion; promote color retention. parts per million expressed as dehydro- Spice extractives in 60 Promote color and fla- acetic acid remains in or on the pre- soluble carriers. vor retention. pared squash. Spreads, artificially col- 100 Promote color retention. ored and lemon-fla- (c) The label or labeling of any pack- vored or orange-fla- age of the additive intended for use in vored. food shall bear adequate directions for 1 By weight of egg yolk portion. use to insure compliance with this sec- (2) With disodium EDTA (disodium tion. ethylenediaminetetraacetate) in the § 172.133 Dimethyl dicarbonate. following foods at not to exceed, in combination, the levels prescribed, cal- Dimethyl dicarbonate (CAS Reg. No. culated as anhydrous C10H12O8N2CaNa2: 4525–33–1) may be safely used in food in accordance with the following pre- Limita- tion scribed conditions: Food (parts Use (a) The additive meets the following per million) specifications: (1) The additive has a purity of not Dressings, nonstandardized .... 75 Preservative. French dressing ...... 75 Do. less than 99.8 percent as determined by Mayonnaise ...... 75 Do. the following titration method: Salad dressing ...... 75 Do. Sandwich spread ...... 100 Do. PRINCIPLES OF METHOD Sauces ...... 75 Do. Dimethyl dicarbonate (DMDC) is mixed (c) To assure safe use of the additive: with excess diisobutylamine with which it (1) The label and labeling of the addi- reacts quantitatively. The excess amine is tive container shall bear, in addition to backtitrated with acid. the other information required by the APPARATUS Act, the name of the additive. (2) The label or labeling of the addi- 250-milliliter (mL) Beaker tive container shall bear adequate use 100-mL Graduate cylinder directions to provide a final food prod- 25-mL Pipette uct that complies with the limitations 10-mL Burette (automatic, eg., Metrohm burette) provided in paragraph (b) of this sec- Stirrer tion. Device for potentiometric titration (d) In the standardized foods listed in Reference electrode paragraph (b) of this section, the addi- Glass electrode tives are used only in compliance with the applicable standards of identity for REAGENTS such foods. Acetone, analytical-grade [42 FR 14491, Mar. 15, 1977, as amended at 48 Solution of 1 N diisobutylamine in chloro- FR 10815, Mar. 15, 1983; 58 FR 52222, Oct. 7, benzene, distilled 1993; 60 FR 33710, June 29, 1995; 65 FR 48379, 1 N Acetic Acid Aug. 8, 2000] PROCEDURE § 172.130 Dehydroacetic acid. Accurately weigh in about 2 grams of the The food additive dehydroacetic acid sample (W) and dissolve in 100 mL acetone. and/or its sodium salt may be safely Add accurately 25 mL of the 1 N diisobutyl- used in accordance with the following amine solution by pipette and allow to stand prescribed conditions: for 5 minutes. Subsequently, titrate the re- (a) The food additive meets the fol- action mixture potentiometrically with 1 N lowing specifications: hydrochloric acid (consumption=a mL) while stirring. For determining the blank con- Dehydroacetic acid: Melting point, 109 °C–111 sumption, carry out the analysis without a °C; assay, minimum 98 percent (dry basis). sample (consumption=b mL).

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CALCULATION cent, in an amount not to exceed 250 parts per million. ()ba− ×13. 4 (c) To ensure the safe use of the food = % DMDC additive, the label of the package con- W taining the additive shall bear, in addi- NOTE: For adding the diisobutylamine so- tion to other information required by lution, always use the same pipette and wait the Federal Food, Drug, and Cosmetic for a further three drops to fall when the Act: flow has stopped. (1) The name of the additive ‘‘di- (2) The additive contains not more methyl dicarbonate.’’ than 2,000 ppm (0.2 percent) dimethyl (2) The intended use of the additive. carbonate as determined by a method (3) Adequate directions for use to en- entitled ‘‘Gas Chromatography Method sure compliance with this section. for Dimethyl Carbonate Impurity in [53 FR 41329, Oct. 21, 1988, as amended at 58 Dimethyl Dicarbonate,’’ which is incor- FR 6091, Jan. 26, 1993; 59 FR 5319, Feb. 4, 1994; porated by reference in accordance 61 FR 14245, Apr. 1, 1996; 61 FR 26788, May 29, with 5 U.S.C. 552(a). Copies are avail- 1996; 66 FR 13653, Mar. 7, 2001] able from the Center for Food Safety and Applied Nutrition (HFS–200), 5100 § 172.135 Disodium EDTA. Paint Branch Pkwy., College Park, MD The food additive disodium EDTA 20740, or at the National Archives and (disodium ethylenediaminetetraace- Records Administration (NARA). For tate) may be safely used in designated information on the availability of this foods for the purposes and in accord- material at NARA, call 202–741–6030, or ance with the following prescribed con- go to: http://www.archives.gov/ ditions: federallregister/ (a) The additive contains a minimum codeloflfederallregulations/ of 99 percent disodium ethylenedia- ibrllocations.html. minetetraacetate dihydrate (b) The additive is used or intended (C10H14O8N2Na2·2H2O). for use as a microbial control agent in (b) It is used or intended for use as the following beverages under normal follows: circumstances of bottling, canning, or (1) Alone, in the following foods at other forms of final packaging, where not to exceed the levels prescribed, cal- 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: Aqueous multivitamin prep- 150 With iron salts as a (1) In wine, dealcoholized wine, and arations. stabilizer for vita- low alcohol wine in an amount not to min B 12 in liquid exceed 200 parts per million. multivitamin preparations. (2) In ready-to-drink teas in an Canned black-eyed peas .... 145 Promote color re- amount not to exceed 250 parts per mil- tention. lion. Canned kidney beans ...... 165 Preservative. Canned strawberry pie filling 500 Promote color re- (3) In carbonated or noncarbonated, tention. nonjuice-containing (less than or equal Cooked sausage ...... 36 As a cure accel- to 1 percent juice), flavored or erator with so- unflavored beverages containing added dium ascorbate or ascorbic acid. electrolytes (5–20 milliequivalents/liter Dressings, nonstandardized 75 Preservative. sodium ion (Na+) and 3–7 milli- French dressing ...... 75 Do. equivalents/liter potassium ion (K+)) in Frozen white potatoes in- 100 Promote color re- cluding cut potatoes. tention. an amount not to exceed 250 parts per Gefilte fish balls or patties in 1 50 Inhibit discoloration. million. packing medium. (4) In carbonated, dilute beverages Legumes (all cooked 165 Promote color re- canned, other than black- tention. containing juice, fruit flavor, or both, eyed peas). with juice content not to exceed 50 per- Mayonnaise ...... 75 Preservative.

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Limita- § 172.140 Ethoxyquin. tion Food (parts Use (a) Ethoxyquin (1,2-dihydro-6-ethoxy- per million) 2,2,4-trimethylquinoline) may be safely used as an antioxidant for preservation Ready-to-eat cereal prod- 2 315 Promote color re- ucts containing dried ba- tention. of color in the production of chili pow- nanas. der, paprika, and ground chili at levels Salad dressing ...... 75 Preservative. not in excess of 100 parts per million. Sandwich spread ...... 100 Do. (b) In order to provide for the safe Sauces ...... 75 Do. use of the additive in feed prepared in 1 Based on total weight of finished product including packing medium. accordance with §§ 573.380 and 573.400 of 2 In dried banana component of cereal product. this chapter, tolerances are established (2) With calcium disodium EDTA for residues of ethoxyquin in or on edi- (calcium disodium ethylenediamine- ble products of animals as follows: tetraacetate; calcium disodium 5 parts per million in or on the uncooked fat (ethylenedinitrilo) tetraacetate), in the of meat from animals except poultry. following foods at not to exceed, in 3 parts per million in or on the uncooked combination, the levels prescribed, cal- liver and fat of poultry. culated as anhydrous C10H12O8N2CaNa2: 0.5 part per million in or on the uncooked muscle meat of animals. Limita- 0.5 part per million in poultry eggs. tion Food (parts Use Zero in milk. per million) § 172.145 Heptylparaben. Dressings, nonstandardized 75 Preservative. (a) The food additive heptylparaben French dressing ...... 75 Do. Mayonnaise ...... 75 Do. is the chemical n-heptyl p-hydroxy- Salad dressing ...... 75 Do. benzoate. Sandwich spread ...... 100 Do. (b) It may be safely used to inhibit Sauces ...... 75 Do. microbiological spoilage in accordance with the following prescribed condi- (3) Alone, as a sequestrant in the tions: nonnutritive sweeteners that are listed (1) In fermented malt beverages in in § 180.37 of this chapter and that, in amounts not to exceed 12 parts per mil- addition, are designed for aqueous solution: Provided, That the amount of the lion. additive, calculated as anhydrous cal- (2) In noncarbonated soft drinks and cium disodium EDTA, does not exceed fruit-based beverages in amounts not 0.1 percent by weight of the dry non- to exceed 20 parts per million, when nutritive sweetener. standards of identity established under (c) To assure the safe use of the addi- section 401 of the Act (21 U.S.C. 341) do tive: not preclude such use. (1) The label and labeling of the additive container shall bear, in addition to § 172.150 4-Hydroxymethyl-2,6-di-tert- the other information required by the butylphenol. act, the name of the additive. The food additive 4-hydroxymethyl- (2) The label or labeling of the addi- 2,6-di-tert-butylphenol may be safely tive container shall bear adequate use used in food in accordance with the fol- directions to provide a final food prod- lowing prescribed conditions: uct that complies with the limitations (a) The additive has a solidification provided in paragraph (b) of this sec- point of 140 °C–141 °C. tion. (b) The additive is used as an anti- (d) In the standardized foods listed in oxidant alone or in combination with paragraphs (b) (1) and (2) of this section other permitted antioxidants. the additives are used only in compli- (c) The total amount of all anti- ance with the applicable standards of oxidants added to such food shall not identity for such foods. exceed 0.02 percent of the oil or fat con- [42 FR 14491, Mar. 15, 1977, as amended at 65 tent of the food, including the essential FR 48379, Aug. 8, 2000] (volatile) oil content of the food.

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§ 172.155 Natamycin (pimaricin). § 172.165 Quaternary ammonium chloride combination. (a) Natamycin (CAS Reg. No. 7681–93– 8), also known as pimaricin, is a pol- The food additive, quaternary ammo- yene macrolide antimycotic substance nium chloride combination, may be possessing an empirical formula of safely used in food in accordance with the following conditions: C33H47NO13 and a molecular weight of 665.7. (a) The additive contains the fol- (b) The additive shall conform to the lowing compounds: n-dodecyl dimethyl following specifications: benzyl ammonium chloride (CAS Reg. No. 139–07–1); n-dodecyl dimethyl ethyl- Purity: 97 percent ±2 percent on an anhy- benzyl ammonium chloride (CAS Reg. drous basis. No. 27479–28–3); n-hexadecyl dimethyl Arsenic: Not more than 1 part per million. benzyl ammonium chloride (CAS Reg. Heavy metals (as Pb): Not more than 20 parts No. 122–18–9); n-octadecyl dimethyl per million. benzyl ammonium chloride (CAS Reg. (c) The additive may be applied on No. 122–19–0); n-tetradecyl dimethyl cheese, as an antimycotic, in amounts benzyl ammonium chloride (CAS Reg. not to exceed 20 milligrams per kilo- No. 139–08–2); n-tetradecyl dimethyl gram (20 parts per million) in the fin- ethylbenzyl ammonium chloride (CAS ished product as determined by Inter- Reg. No. 27479–29–4). national Dairy Federation (IDF) Stand- (b) The additive meets the following ard 140A:1992, ‘‘Cheese and Cheese specifications: pH (5 percent active so- Rind-Determination of Natamycin Con- lution) 7.0–8.0; total amines, maximum tent-Method by Molecular Absorption 1 percent as combined free amines and Spectrometry and by High-Perform- amine hydrochlorides. ance Liquid Chromatography,’’ which (c) The additive is used as an anti- is incorporated by reference. The Di- microbial agent, as defined in rector of the Office of the Federal Reg- § 170.3(o)(2) of this chapter, in raw sugar ister approves this incorporation by cane juice. It is added prior to clari- reference in accordance with 5 U.S.C. fication when further processing of the 552(a) and 1 CFR part 51. Copies are sugar cane juice must be delayed. available from the Division of Product (d) The additive is applied to the Policy (HFS–206), Center for Food Safe- sugar juice in the following quantities, ty and Applied Nutrition, Food and based on the weight of the raw cane: Drug Administration, 5100 Paint Parts per Branch Pkwy., College Park, MD 20740, Component million or may be examined at the Center for n-Dodecyl dimethyl benzyl ammonium chloride 0.25–1.0 Food Safety and Applied Nutrition’s n-Dodecyl dimethyl ethylbenzyl ammonium Library, 5100 Paint Branch Pkwy., Col- chloride ...... 3.4–13.5 lege Park, MD 20740, or at the National n-Hexadecyl dimethyl benzyl ammonium chlo- Archives and Records Administration ride ...... 1.5–6.0 n-Octadecyl dimethyl benzyl ammonium chlo- (NARA). For information on the avail- ride ...... 0.25–1.0 ability of this material at NARA, call n-Tetradecyl dimethyl benzyl ammonium chlo- 202–741–6030, or go to: http:// ride ...... 3.0–12.0 n-Tetradecyl dimethyl ethylbenzyl ammonium www.archives.gov/federallregister/ chloride ...... 1.6–6.5 codeloflfederallregulations/ ibrllocations.html. [50 FR 3890, Jan. 29, 1985] [47 FR 26823, June 22, 1982, as amended at 50 FR 49536, Dec. 3, 1985; 63 FR 66015, Dec. 1, § 172.167 Silver nitrate and hydrogen 1998; 66 FR 13847, Mar. 8, 2001] peroxide solution. An aqueous solution containing a § 172.160 Potassium nitrate. mixture of silver nitrate and hydrogen The food additive potassium nitrate peroxide may be safely used in accord- may be safely used as a curing agent in ance with the following prescribed con- the processing of cod roe, in an amount ditions: not to exceed 200 parts per million of (a) The additive is used as an anti- the finished roe. microbial agent in bottled water.

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(b) Hydrogen peroxide meets the at the National Archives and Records specifications of the ‘‘Food Chemicals Administration (NARA). For informa- Codex,’’ 6th ed. (2008), pp. 463 and 464, tion on the availability of this mate- which is incorporated by reference. The rial at NARA, call 202–741–6030 or go to: Director of the Federal Register ap- http://www.archives.gov/federallregister/ proves this incorporation by reference codelofl federallregulations/ in accordance with 5 U.S.C. 552(a) and 1 ibrllocations.html. CFR part 51. You may obtain copies (e) Substances generally recognized from the United States Pharmacopeial as safe in or on food may be used to Convention, 12601 Twinbrook Pkwy., stabilize the additive to ensure that Rockville, MD 20852 (Internet address the additive will perform its intended http://www.usp.org). Copies may be ex- technical effect. amined at the Center for Food Safety (f) The additive may not be added to and Applied Nutrition’s Library, Food bottled water that has been filtered or and Drug Administration, 5100 Paint is intended to be filtered through a sil- Branch Pkwy., College Park, MD 20740, ver-containing water filter. 301–436–2163, or at the National Ar- (g) Bottled water must meet the chives and Records Administration quality standards for bottled water in (NARA). For information on the avail- § 165.110(b)(2) through (b)(5) of this ability of this material at NARA, call chapter, including the limits specified 202–741–6030 or go to: http:// for total silver and nitrate, unless the www.archives.gov/federallregister/ water bears a label statement of sub- codeloflfederallregulations/ standard quality, as provided for under ibrllocations.html. § 165.110(c) of this chapter. (c) The amount of silver added will not exceed 17 micrograms per kilogram [74 FR 11478, Mar. 18, 2009] in the treated bottled water, and the amount of hydrogen peroxide will not § 172.170 Sodium nitrate. exceed 23 milligrams per kilogram in The food additive sodium nitrate the treated bottled water. Analyses for may be safely used in or on specified silver and hydrogen peroxide shall be foods in accordance with the following conducted on samples of treated bot- prescribed conditions: tled water at the site of bottling, using (a) It is used or intended for use as samples of the water intended for follows: treatment for the blank determination. (d)(1) The amount of silver in the (1) As a preservative and color fixa- treated bottled water is determined tive, with or without sodium nitrite, in using the method for silver designated smoked, cured sablefish, smoked, cured in 21 CFR 165.110(b)(4)(iii)(G)(2)(i). salmon, and smoked, cured shad, so (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 Center parts per million in the finished meat for Food Safety and Applied Nutri- product. tion’s Library, Food and Drug Admin- (b) To assure safe use of the additive, istration, 5100 Paint Branch Pkwy., in addition to the other information re- College Park, MD 20740, 301–436–2163, or quired by the Act:

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(1) The label of the additive or of a (ii) A statement of the concentration mixture containing the additive shall of the additive in any mixture. bear: (2) If in a retail package intended for (i) The name of the additive. household use, the label and labeling of (ii) A statement of the concentration the additive, or of a mixture con- of the additive in any mixture. taining the additive, shall bear ade- (2) If in a retail package intended for quate directions for use to provide a household use, the label and labeling of final food product which complies with the additive, or of a mixture con- the limitations prescribed in paragraph taining the additive, shall bear ade- (a) of this section. quate directions for use to provide a (3) If in a retail package intended for final food product that complies with household use, the label of the addi- the limitations prescribed in paragraph tive, or of a mixture containing the ad- (a) of this section. ditive, shall bear the statement ‘‘Keep (3) If in a retail package intended for out of the reach of children’’. household use, the label of the additive or of a mixture containing the addi- § 172.177 Sodium nitrite used in proc- tive, shall bear the statement ‘‘Keep essing smoked chub. out of the reach of children’’. The food additive sodium nitrite may be safely used in combination with salt § 172.175 Sodium nitrite. (NaCl) to aid in inhibiting the out- The food additive sodium nitrite may growth and toxin formation from Clos- be safely used in or on specified foods tridium botulinum type E in the com- in accordance with the following pre- mercial processing of smoked chub in scribed conditions: accordance with the following pre- (a) It is used or intended for use as scribed conditions: follows: (a) All fish in smoking establish- (1) As a color fixative in smoked ments shall be clean and wholesome cured tunafish products so that the and shall be expeditiously processed, level of sodium nitrite does not exceed packed, and stored under adequate san- 10 parts per million (0.001 percent) in itary conditions in accordance with the finished product. good manufacturing practice. (2) As a preservative and color fixa- (b) The brining procedure is con- tive, with or without sodium nitrate, trolled in such a manner that the in smoked, cured sablefish, smoked, water phase portion of the edible por- cured salmon, and smoked, cured shad tion of the finished smoked product has so that the level of sodium nitrite does a salt (NaCl) content of not less than not exceed 200 parts per million and the 3.5 percent, as measured in the loin level of sodium nitrate does not exceed muscle, and the sodium nitrite content 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

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storage and distribution. All shipping exceed 0.02 percent of the oil or fat con- containers, retail packages, and ship- tent of the food, including the essential ping records shall indicate with appro- (volatile) oil content of the food. priate notice the perishable nature of the product and specify that the prod- § 172.190 THBP. uct shall be held under refrigeration (38 The food additive THBP (2,4,5-tri- °F or below) until consumed. hydroxybutyrophenone) may be safely (e) To assure safe use of the additive: used in food in accordance with the fol- (1) The label and labeling of the addi- lowing prescribed conditions: tive container shall bear, in addition to (a) The food additive has a melting the other information required by the point of 149 °C–153 °C. Act, the name of the additive. (b) It is used as an antioxidant alone (2) The label or labeling of the addi- or in combination with other permitted tive container shall bear adequate di- antioxidants. rections to assure use in compliance (c) The total antioxidant content of a with the provisions of this section. food containing the additive will not § 172.180 Stannous chloride. exceed 0.02 percent of the oil or fat content of the food, including the essential The food additive stannous chloride (volatile) oil content of the food. may be safely used for color retention in asparagus packed in glass, with lids lined with an inert material, in an Subpart C—Coatings, Films and amount not to exceed 20 parts per mil- Related Substances lion calculated as tin (Sn). § 172.210 Coatings on fresh citrus fruit. § 172.185 TBHQ. Coatings may be applied to fresh cit- The food additive TBHQ, which is the rus fruit for protection of the fruit in chemical 2-(1,1-dimethylethyl)-1,4-benz- accordance with the following condi- enediol (Chemical Abstracts Service tions: Registry Number 1948–33–0), also known (a) The coating is applied in the min- as tertiary butylhydroquinone, may be imum amount required to accomplish safely used in food in accordance with the intended effect. the following prescribed conditions: (b) The coating may be formulated (a) The food additive has a melting from the following components, each point of 126.5 °C–128.5 °C. used in the minimum quantity required (b) It is used as an antioxidant alone to accomplish the intended effect: or in combination with BHA and/or (1) Substances generally recognized BHT. as safe for the purpose or previously (c) The total antioxidant content of a sanctioned for the purpose. food containing the additive will not (2) One or more of the following:

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.

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Component Limitations

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.

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. Barr Harbor Dr., West Conshohocken, The food additive coumarone-indene Philadelphia, PA 19428-2959, or may be resin may be safely used on grapefruit, examined at the National Archives and lemons, limes, oranges, tangelos, and Records Administration (NARA). For tangerines in accordance with the fol- information on the availability of this lowing prescribed conditions: material at NARA, call 202–741–6030, or (a) The food additive is manufactured go to: http://www.archives.gov/ by the polymerization of a crude, federallregister/ heavy coal-tar solvent naphtha meet- codeloflfederallregulations/ ing the following specifications: ibrllocations.html. (1) It is a mixture of indene, indan (2) Refractive index (n25/D) 1.63–1.64. (hydrindene), substituted benzenes, and (c) It is used or intended for use as a related compounds. protective coating for grapefruit, lem- (2) It contains no more than 0.25 per- ons, limes, oranges, tangelos, and tan- cent tar bases. gerines whereby the maximum amount (3) 95 percent distills in the range 167 of the resin remaining on the fruit does °C–184 °C. not exceed 200 parts per million on a (b) The food additive meets the fol- fresh-weight basis. lowing specifications: (d) To assure safe use of the additive: (1) Softening point, ring and ball: 126 (1) The label of the market package °C minimum as determined by ASTM or any intermediate premix of the ad- method E28–67 (Reapproved 1982), ditive shall bear, in addition to the ‘‘Standard Test Method for Softening other information required by the act: Point by Ring-and-Ball Apparatus,’’ (i) The name of the additive, cou- which is incorporated by reference. marone-indene resin. Copies may be obtained from the Amer- (ii) A statement of the concentration ican Society for Testing Materials, 100 of the additive therein.

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(2) The label or accompanying label- Arabinogalactan—Complying with § 172.610; ing shall bear adequate directions that, as adjuvant. if followed, will result in a finished Silicon dioxide—Complying with § 172.480; as food not in conflict with the require- adjuvant. ments of this section. (3) In lieu of the components listed in paragraph (a)(2) of this section, the fol- [42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10103, Mar. 19, 1984] lowing components:

§ 172.225 Methyl and ethyl esters of COMPONENT AND LIMITATIONS fatty acids produced from edible Glutaraldehyde—As cross-linking agent for fats and oils. insolubilizing a coacervate of gum arabic Methyl esters and ethyl esters of and gelatin. fatty acids produced from edible fats n-Octyl alcohol—As a defoamer. and oils may be safely used in food, (4) In lieu of the components listed in subject to the following prescribed con- paragraphs (a)(2) and (3) of this section, ditions: the following component: (a) The additive consists of a mixture of either methyl or ethyl esters of COMPONENT AND LIMITATIONS fatty acids produced from edible fats and oils and meets the following speci- Petroleum wax—Complying with § 172.886. fications: Not to exceed 50 percent by combined weight of the microcapsule and spice-fla- (1) Not less than 90 percent methyl or voring substance. ethyl esters of fatty acids. (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 microcapsules formulated from compo- [57 FR 12711, Apr. 13, 1992] nents listed in paragraph (a)(2) of this section may be used only for encap- § 172.230 Microcapsules for flavoring sulating lemon oil, distilled lime oil, substances. 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.

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(a) It is used as the salt(s) of one or APPARATUS more of the fatty acids meeting the re- Separatory funnels. 250-milliliter, and 2,000- quirements of § 172.860, as a component milliliter capacity, equipped with tetra- of protective coatings applied to fresh fluoroethylene polymer stopcocks. fruits and vegetables. Erlenmeyer flask. 125-milliliter with 24/40 standard taper neck. (b) It is used at a level not in excess Evaporation flask. 250-milliliter capacity of that reasonably required to produce all-glass flask equipped with 24/40 standard its intended effect. taper stopper having inlet and outlet tubes to permit passage of nitrogen across the sur- § 172.250 Petroleum naphtha. face of the container liquid to be evaporated. Condenser. 24/40 joints, fitted with drying Petroleum naphtha may be safely tube, length optional. used in food in accordance with the fol- Spectrophotometric cells. Fused quartz cells, lowing conditions: optical path length in the range of 5,000 cen- ± (a) The additive is a mixture of liquid timeters 0.005 centimeter; also for checking spectrophotometer performance only, optical hydrocarbons, essentially paraffinic path length in the range 1,000 centimeter and naphthenic in nature obtained ±0.005 centimeter. With distilled water in the from petroleum, cells, determine any absorbance difference. (b) The additive is refined to meet Spectrophotometer. Spectral range 250–400 μ μ the following specifications when sub- m with spectral slit width of 2 m or less; under instrument operating conditions for jected to the procedures described in these absorbance measurements, the spectro- this paragraph. photometer shall also meet the following (1) Boiling-point range: 175 °F–300 °F. performance requirements: (2) Nonvolatile residue: 0.002 gram Absorbance repeatability, ±0.01 at 0.4 absorb- per 100 milliliters maximum. ance. (3) Ultraviolet absorbance limits, as Absorbance accuracy, 1 ±0.05 at 0.4 absorb- follows: ance. Wavelength repeatability, ±0.2 millimicron. ± Maximum Wavelength accuracy, 1.0 millimicron. absorb- Ultraviolet lamp. Long wavelength (3400– ance per Wavelength (milli-microns) centimeter 3800A°). optical pathlength REAGENTS

280–289 ...... 0.15 Isooctane (2,2,4-trimethylpentane). Use 180 290–299 ...... 13 milliliters in a 250-milliliter Erlenmeyer 300–359 ...... 08 flask, add 1 milliliter of purified n-hexa- 360–400 ...... 02 decane, insert the head assembly, allow nitrogen gas to flow into the inlet tube and connect the outlet tube to a solvent trap and ANALYTICAL SPECIFICATION FOR PETROLEUM vacuum line in such a way as to prevent any NAPHTHA back flow of condensate into the flask. The

GENERAL INSTRUCTIONS 1 As determined by procedure using potas- All glassware should be scrupulously sium chromate for reference standard and cleaned to remove all organic matter such as described in National Bureau of Standards oil, grease, detergent residues, etc. Examine Circular 484, Spectrophotometry, U.S. De- all glassware, including stoppers and stop- partment of Commerce, (1949). The accuracy cocks, under ultraviolet light to detect any is to be determined by comparison with the residual fluorescent contamination. As a pre- standard values at 290, 345, and 400 milli- cautionary measure, it is recommended prac- microns. The procedure is incorporated by tice to rinse all glassware with purified iso- reference. Copies of the material incor- octane immediately before use. No grease is porated by reference are available from the to be used on stopcocks or joints. Great care Center for Food Safety and Applied Nutri- to avoid contamination of petroleum naph- tion (HFS–200), Food and Drug Administra- tha samples in handling and to assure ab- tion, 5100 Paint Branch Pkwy., College Park, sence of any extraneous material arising MD 20740, or available for inspection at the National Archives and Records Administra- from inadequate packaging is essential. Be- tion (NARA). For information on the avail- cause some of the polynuclear hydrocarbons ability of this material at NARA, call 202– sought in this test are very susceptible to 741–6030, or go to: http://www.archives.gov/ photo-oxidation, the entire procedure is to federallregister/codeloflfederallregulations/ be carried out under subdued light. ibrllocations.html.

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contents of the flask are evaporated on a tube into the flask, mix until the sodium steam bath until 1 milliliter of residue re- borohydride is dissolved, and allow to stand mains. Dissolve the 1 milliliter of hexa- for 30 minutes at room temperature, with decane residue in isooctane and make up to intermittent swirling. At the end of this 25 milliliters. Determine the absorbance in a time, disconnect the flask and evaporate the 5-centimeter path length cell compared to methyl alcohol on the steam bath under ni- isooctane as reference. The absorbance trogen until sodium borohydride begins to should not exceed 0.01 per centimeter path drop out of solution. Remove the flask and length between 280–400 mμ. If necessary, iso- let it cool. octane may be purified by passage through a Add 6 milliliters of isooctane to the flask column of activated silica gel (Grade 12, Da- and swirl to wash the crystalline slurry. vidson Chemical Co., Baltimore, Md., or Carefully transfer the isooctane extract to a equivalent) or by distillation. 250-milliliter separatory funnel. Dissolve the Methyl alcohol, A.C.S. reagent grade. Use 10 crystals in the flask with about 25 milliliters milliliters and proceed as with isooctane. of distilled water and pour this also into the The absorbance per centimeter of path separatory funnel. Adjust the water volume length should be 0.00 between 280–400 mμ. in the separatory funnel to about 100 milli- Methyl alcohol may be purified by simple liters and shake for 1 minute. After separa- 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/

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codeloflfederallregulations/ scribed in item 2.3 of the table in ibrllocations.html. § 177.1520(c) of this chapter. The Determination of nonvolatile residue. For hy- oxidized polyethylene has a minimum drocarbons boiling below 121 °C, determine the nonvolatile residue by ASTM method number average molecular weight of D1353–78, ‘‘Standard Test Method for Non- 1,200, as determined by high tempera- volatile Matter in Volatile Solvents for Use ture vapor pressure osmometry; con- in Paint, Varnish, Lacquer, and Related tains a maximum of 5 percent by Products;’’ for those boiling above 121 °C, use weight of total oxygen; and has an acid ASTM method D381–80, ‘‘Standard Test value of 9 to 19. Method for Existent Gum in Fuels by Jet (b) The additive is used or intended Evaporation,’’ which methods are incorporated by reference. Copies may be obtained for use as a protective coating or com- from the American Society for Testing Ma- ponent of protective coatings for fresh terials, 100 Barr Harbor Dr., West avocados, bananas, beets, coconuts, Conshohocken, Philadelphia, PA 19428-2959, eggplant, garlic, grapefruit, lemons, or may be examined at the National Ar- limes, mango, muskmelons, onions, or- chives and Records Administration (NARA). anges, papaya, peas (in pods), pine- 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/ codeloflfederallregulations/ gerines, turnips, watermelon, Brazil ibrllocations.html. nuts, chestnuts, filberts, hazelnuts, pe- 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 that reasonably required to accomplish Sulfate butyl oleate may be safely the intended effect or to exceed any used in food, subject to the following prescribed limitations. prescribed conditions: (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

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be safely used as a component of food, federallregister/ subject to the following restrictions: codeloflfederallregulations/ (a) The additive is prepared with 50 ibrllocations.html. percent Fischer-Tropsch process syn- (b) It is used or intended for use as thetic paraffin, meeting the definition follows: and specifications of § 172.615, and 50 (1) As a moisture barrier on soft gela- percent of such synthetic paraffin to tin capsules in an amount not to ex- which is bonded succinic anhydride and ceed 0.07 percent of the weight of the succinic acid derivatives of isopropyl capsule. alcohol, polyethylene glycol, and poly- (2) As a moisture barrier on powders propylene glycol. It consists of a mix- of ascorbic acid or its salts in an ture of the Fischer-Tropsch process amount not to exceed 7 percent of the paraffin (alkane), alkyl succinic anhy- weight of the powder. dride, alkyl succinic anhydride iso- [42 FR 14491, Mar. 15, 1977, as amended at 49 propyl half ester, dialkyl succinic an- FR 10104, Mar. 19, 1984] hydride polyethylene glycol half ester, 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 § 172.280 Terpene resin. acid and nicotinamide, melting in the 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 an- Copies may be obtained from the Amer- hydrous form or as the hydrochloride, ican Society for Testing Materials, 100 sodium or potassium salts: Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be L-Alanine examined at the National Archives and L-Arginine L-Asparagine Records Administration (NARA). For L-Aspartic acid information on the availability of this L-Cysteine material at NARA, call 202–741–6030, or L-Cystine go to: http://www.archives.gov/ L-Glutamic acid

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L-Glutamine Records Administration (NARA). For Aminoacetic acid (glycine) information on the availability of this L-Histidine material at NARA, call 202–741–6030, or L-Isoleucine L-Leucine go to: http://www.archives.gov/ L-Lysine federallregister/ DL-Methionine (not for infant foods) codeloflfederallregulations/ L-Methionine ibrllocations.html.) for the following: L-Phenylalanine L-Proline L-Asparagine L-Serine L-Aspartic acid L-Threonine L-Glutamine L-Tryptophan L-Histidine L-Tyrosine (c) The additive(s) is used or intended L-Valine for use to significantly improve the bi- (b) The food additive meets the fol- ological quality of the total protein in lowing specifications: a food containing naturally occurring (1) As found in ‘‘Food Chemicals primarily-intact protein that is consid- Codex,’’ National Academy of Sciences/ ered a significant dietary protein National Research Council (NAS/NRC), source, provided that: 3d Ed. (1981), which is incorporated by (1) A reasonable daily adult intake of reference (Copies may be obtained from the finished food furnishes at least 6.5 the National Academy Press, 2101 Con- grams of naturally occurring primarily stitution Ave. NW., Washington, DC intact protein (based upon 10 percent of 20418, or may be examined at the Na- the daily allowance for the ‘‘reference’’ tional Archives and Records Adminis- adult male recommended by the Na- tration (NARA). For information on tional Academy of Sciences in ‘‘Rec- the availability of this material at ommended Dietary Allowances,’’ NAS NARA, call 202–741–6030, or go to: http:// Publication No. 1694, 7th Ed. (1968), www.archives.gov/federallregister/ which is incorporated by reference. codeloflfederallregulations/ Copies are available from the Center ibrllocations.html.) for the following: for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra- L-Alanine tion, 5100 Paint Branch Pkwy., College L-Arginine Park, MD 20740, or available for inspec- L-Arginine Monohydrochloride L-Cysteine Monohydrochloride tion at the National Archives and L-Cystine Records Administration (NARA). For Aminoacetic acid (glycine) information on the availability of this L-Leucine material at NARA, call 202–741–6030, or DL-Methionine go to: http://www.archives.gov/ L-Methionine federallregister/ L-Tryptophan codeloflfederallregulations/ L-Phenylalanine ibrllocations.html. L-Proline L-Serine (2) The additive(s) results in a pro- L-Threonine tein efficiency ratio (PER) of protein Glutamic Acid Hydrochloride in the finished ready-to-eat food equiv- L-Isoleucine alent to casein as determined by the L-Lysine Monohydrochloride method specified in paragraph (d) of Monopotassium L-glutamate this section. L-Tyrosine (3) Each amino acid (or combination L-Valine of the minimum number necessary to (2) As found in ‘‘Specifications and achieve a statistically significant in- Criteria for Biochemical Compounds,’’ crease) added results in a statistically NAS/NRC Publication, 3rd Ed. (1972), significant increase in the PER as de- which is incorporated by reference termined by the method described in (Copies are available from the Center paragraph (d) of this section. The min- for Food Safety and Applied Nutrition imum amount of the amino acid(s) to (HFS–200), Food and Drug Administra- achieve the desired effect must be used tion, 5100 Paint Branch Pkwy., College and the increase in PER over the pri- Park, MD 20740, or available for inspec- marily-intact naturally occurring pro- tion at the National Archives and tein in the food must be substantiated

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as a statistically significant difference make such records available upon re- with at least a probability (P) value of quest at all reasonable hours by any of- less than 0.05. ficer or employee of the Food and Drug (4) The amount of the additive added Administration, or any other officer or for nutritive purposes plus the amount employee acting on behalf of the Sec- naturally present in free and combined retary of Health and Human Services (as protein) form does not exceed the and shall permit such officer or em- following levels of amino acids ex- ployee to conduct such inventories of pressed as percent by weight of the raw and finished materials on hand as total protein of the finished food: he deems necessary and otherwise to check the correctness of such records. Percent by weight of (e) To assure safe use of the additive, total pro- the label and labeling of the additive tein (expressed as and any premix thereof shall bear, in free amino addition to the other information re- acid) quired by the Act, the following: L-Alanine ...... 6.1 (1) The name of the amino acid(s) L-Arginine ...... 6.6 contained therein including the spe- L-Aspartic acid (including L-asparagine) ...... 7.0 cific optical and chemical form. L-Cystine (including L-cysteine) ...... 2.3 L-Glutamic acid (including L-glutamine) ...... 12.4 (2) The amounts of each amino acid Aminoacetic acid (glycine) ...... 3.5 contained in any mixture. L-Histidine ...... 2.4 (3) Adequate directions for use to L-Isoleucine ...... 6.6 L-Leucine ...... 8.8 provide a finished food meeting the L-Lysine ...... 6.4 limitations prescribed by paragraph (c) L- and DL-Methionine ...... 3.1 of this section. L-Phenylalanine ...... 5.8 L-Proline ...... 4.2 (f) The food additive amino acids L-Serine ...... 8.4 added as nutrients to special dietary L-Threonine ...... 5.0 foods that are intended for use solely L-Tryptophan ...... 1.6 under medical supervision to meet nu- L-Tyrosine ...... 4.3 L-Valine ...... 7.4 tritional requirements in specific medical conditions and comply with the re- (d) Compliance with the limitations quirements of part 105 of this chapter concerning PER under paragraph (c) of are exempt from the limitations in this section shall be determined by the paragraphs (c) and (d) of this section method described in sections 43.212– and may be used in such foods at levels 43.216, ‘‘Official Methods of Analysis of not to exceed good manufacturing the Association of Official Analytical practices. Chemists,’’ 13th Ed. (1980), which is in- [42 FR 14491, Mar. 15, 1977; 42 FR 56728, Oct. corporated by reference. Copies may be 28, 1977, as amended at 47 FR 11836, Mar. 19, obtained from the AOAC INTER- 1982; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, NATIONAL, 481 North Frederick Ave., June 12, 1989; 59 FR 14550, Mar. 29, 1994; 61 FR suite 500, Gaithersburg, MD 20877, or 14480, Apr. 2, 1996] may be examined at the National Ar- chives and Records Administration § 172.325 Bakers yeast protein. (NARA). For information on the avail- Bakers yeast protein may be safely ability of this material at NARA, call used in food in accordance with the fol- 202–741–6030, or go to: http:// lowing conditions: www.archives.gov/federallregister/ (a) Bakers yeast protein is the insol- codeloflfederallregulations/ uble proteinaceous material remaining ibrllocations.html. Each manufacturer after the mechanical rupture of yeast or person employing the additive(s) cells of Saccharomyces cerevisiae and re- under the provisions of this section moval of whole cell walls by cen- shall keep and maintain throughout trifugation and separation of soluble the period of his use of the additive(s) cellular materials. and for a minimum of 3 years there- (b) The additive meets the following after, records of the tests required by specifications on a dry weight basis: this paragraph and other records re- (1) Zinc salts less than 500 parts per quired to assure effectiveness and com- million (ppm) as zinc. pliance with this regulation and shall (2) Nucleic acid less than 2 percent.

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(3) Less than 0.3 ppm arsenic, 0.1 ppm (1) The additive shall consist prin- cadmium, 0.4 ppm lead, 0.05 ppm mer- cipally of dried fish protein prepared cury, and 0.3 ppm selenium. from the edible portions of fish after (c) The viable microbial content of removal of the heads, fins, tails, bones, the finished ingredient is: scales, viscera, and intestinal contents. (1) Less than 10,000 organisms/gram (2) The additive shall be derived only by aerobic plate count. from species of bony fish that are gen- (2) Less than 10 yeasts and molds/ erally recognized by qualified sci- gram. entists as safe for human consumption (3) Negative for Salmonella, E. coli, and that can be processed as prescribed coagulase positive Staphylococci, Clos- to meet the required specifications. tridium perfringens, Clostridium botu- (3) Only wholesome fresh fish other- linum, or any other recognized micro- wise suitable for human consumption bial pathogen or any harmful microbial may be used. The fish shall be handled toxin. expeditiously under sanitary condi- (d) The ingredient is used in food as tions. These conditions shall be in ac- a nutrient supplement as defined in cordance with recognized good manu- § 170.3(o)(20) of this chapter. facturing practice for fish to be used as human food. § 172.330 Calcium pantothenate, cal- (4) The additive shall be prepared by cium chloride double salt. extraction with hexane and food-grade 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 excess of that reasonably required to 1 Copies are available from: AOAC INTER- produce its intended effect. NATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or examined at § 172.340 Fish protein isolate. the National Archives and Records Adminis- tration (NARA). For information on the (a) The food additive fish protein iso- availability of this material at NARA, call late may be safely used as a food sup- 202–741–6030, or go to: http://www.archives.gov/ plement in accordance with the fol- federallregister/codeloflfederallregulations/ lowing prescribed conditions: ibrllocations.html.

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million of hexane and 3.5 percent eth- the Orphan Drug Act (21 U.S.C. anol by weight. 360ee(b)(3)), at levels not to exceed the [46 FR 38072, July 24, 1981, as amended at 47 amount necessary to meet the distinc- FR 53344, Nov. 26, 1982; 54 FR 24897, June 12, tive nutritional requirements of the 1989] disease or condition for which the food is formulated. § 172.345 Folic acid (folacin). (g) Folic acid may be added to food Folic acid (CAS Reg. No. 59–30–3), for special dietary use at levels not to also known as folacin or folate, may be exceed the amount necessary to meet safely used in food as a nutrient in ac- the special dietary needs for which the cordance with the following prescribed food is formulated. conditions: (h) Folic acid may be added to foods (a) Folic acid is the chemical N-[4- represented as meal-replacement prod- [[(2-amino-1,4-dihydro-4-oxo-6-pteri- ucts, in amounts not to exceed: dinyl)methyl]amino]benzoyl]-L-glu- μ tamic acid. (1) Four hundred g per serving if the (b) Folic acid meets the specifica- food is a meal-replacement that is rep- tions of the ‘‘Food Chemicals Codex,’’ resented for use once per day; or 4th ed. (1996), pp. 157–158, which is in- (2) Two hundred μg per serving if the corporated 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 Copies are available from the National day. Academy Press, Box 285, 2101 Constitu- [61 FR 8807, Mar. 5, 1996, as amended at 61 FR tion Ave. NW., Washington, DC 20055 27779, June 3, 1996; 64 FR 1758, Jan. 12, 1999] (Internet address http://www.nap.edu), or may be examined at the Center for § 172.350 Fumaric acid and salts of fu- Food Safety and Applied Nutrition’s maric acid. Library, Food and Drug Administra- tion, 5100 Paint Branch Pkwy., College Fumaric acid and its calcium, fer- Park, MD 20740, or at the National Ar- rous, magnesium, potassium, and so- chives and Records Administration dium salts may be safely used in food (NARA). For information on the avail- in accordance with the following pre- ability of this material at NARA, call scribed conditions: 202–741–6030, or go to: http:// (a) The additives meet the following www.archives.gov/federallregister/ specifications: codeloflfederallregulations/ (1) Fumaric acid contains a minimum ibrllocations.html. of 99.5 percent by weight of fumaric (c) Folic acid may be added to foods acid, calculated on the anhydrous subject to a standard of identity estab- basis. lished under section 401 of the Federal (2) The calcium, magnesium, potas- Food, Drug, and Cosmetic Act (the act) sium, and sodium salts contain a min- when the standard of identity specifi- imum of 99 percent by weight of the re- cally provides for the addition of folic spective salt, calculated on the anhy- acid. drous basis. Ferrous fumarate contains (d) Folic acid may be added, at levels a minimum of 31.3 percent total iron not to exceed 400 micrograms (μg) per serving, to breakfast cereals, as defined and not more than 2 percent ferric under § 170.3(n)(4) of this chapter, and iron. to corn grits at a level such that each (b) With the exception of ferrous fu- pound of corn grits contains not more marate, fumaric acid and the named than 1.0 milligram of folic acid. salts are used singly or in combination (e) Folic acid may be added to infant in food at a level not in excess of the formula in accordance with section amount reasonably required to accom- 412(i)(1) of the act or with regulations plish the intended effect. issued under section 412(i)(2) of the act (c) Ferrous fumarate is used as a which are codified in § 107.100 of this source of iron in foods for special die- chapter. tary use, when the use is consistent (f) Folic acid may be added to a med- with good nutrition practice. ical food, as defined in section 5(b)(3) of

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§ 172.365 Kelp. tate; 50 ppm ethyl alcohol; 10 ppm Kelp may be safely added to a food as methyl alcohol; and 10 ppm acetone, a source of the essential mineral io- when used as processing solvents. dine, provided the maximum intake of (c) The additive is used or intended the food as may be consumed during a for use as a source of L-methionine to period of one day, or as directed for use improve significantly the biological in the case of a dietary supplement, quality of the total protein in a food will not result in daily ingestion of the containing naturally occurring pri- 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

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(NARA). For information on the avail- (a) Potassium iodide may be safely ability of this material at NARA, call added to a food as a source of the es- 202–741–6030, or go to: http:// sential mineral iodine, provided the www.archives.gov/federallregister/ maximum intake of the food as may be codeloflfederallregulations/ consumed during a period of one day, ibrllocations.html. Each manufacturer or as directed for use in the case of a or person employing the additive under dietary supplement, will not result in the provisions of this section shall daily ingestion of the additive so as to 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 D2. quired by the Act, the following: (1) The name of the additive con- Vitamin D2 may be used safely in tained therein. foods as a nutrient supplement defined (2) The amounts of additive and each under § 170.3(o)(20) of this chapter in ac- amino acid contained in any mixture. cordance with the following prescribed conditions: (3) Adequate directions for use to , also known as provide a finished food meeting the (a) Vitamin D2 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 D is pro- (f) When the food additive is added as 2 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 requirements in specific medical condi- (b) Vitamin D2 meets the specifications and these foods comply with the tions of the Food Chemicals Codex, 6th requirements of part 105 of this chap- ed. (2008), pp. 1013 and 1014, which is inter, the food additive is exempt from corporated by reference. The Director the limitations in paragraphs (c)(1) of the Federal Register approves this through (4) and (d) of this section and incorporation by reference in accord- may be used in those foods at levels ance with 5 U.S.C 552(a) and 1 CFR part not to exceed good manufacturing 51. You may obtain a copy from the practices. United States Pharmacopeial Conven- tion, 12601 Twinbrook Pkwy., Rock- [43 FR 27784, June 27, 1978, as amended at 46 ville, MD 20852 (Internet address: http:// FR 59968, Dec. 8, 1981; 49 FR 10104, Mar. 19, www.usp.org). You may inspect a copy 1984; 54 FR 24897, June 12, 1989] at the Center for Food Safety and Ap- plied Nutrition’s Library, Food and § 172.375 Potassium iodide. Drug Administration, 5100 Paint The food additive potassium iodide Branch Pkwy., College Park, MD 20740, may be safely used in accordance with 301–436–1071, or at the National Ar- the following prescribed conditions: chives and Records Administration

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(NARA). For information on the avail- codeloflfederallregulations/ ability of this material at NARA, call ibrllocations.html. 202–741–6030, or go to: http:// (c) The additive may be used as fol- www.archives.gov/federallregister/ lows:

Category of Food Maximum Levels in Food (as Served)

Soy beverages 50 International Units (IU)/100 grams (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] fined under § 170.3(n)(35) of this chapter) that are fortified with greater than or § 172.380 Vitamin D3. equal to 33 percent of the reference Vitamin D3 may be used safely in daily intake (RDI) of calcium per 240 foods as a nutrient supplement defined mL, excluding fruit juices that are spe- under § 170.3(o)(20) of this chapter in ac- cially formulated or processed for in- cordance with the following prescribed fants. conditions: (2) At levels not to exceed 100 IU per (a) Vitamin D3, also known as chole- 240 mL in fruit juice drinks (as defined calciferol, is the chemical 9,10- under § 170.3(n)(35) of this chapter) that seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. are fortified with greater than or equal Vitamin D3 occurs in and is isolated to 10 percent of the RDI of calcium per from fish liver oils. It also is manufac- 240 mL, excluding fruit juice drinks tured by ultraviolet irradiation of 7-de- that are specially formulated or proc- hydrocholesterol produced from choles- essed for infants. terol and is purified by crystallization. (3) At levels not to exceed 140 IU per (b) Vitamin D3 meets the specifications of the Food Chemicals Codex, 5th 240 mL (prepared beverage) in soy-pro- ed. (2004), pp. 498–499, which is incor- tein based meal replacement beverages porated by reference. The Director of (powder or liquid) that are represented the Office of the Federal Register ap- for special dietary use in reducing or proves this incorporation by reference maintaining body weight in accordance in accordance with 5 U.S.C. 552(a) and 1 with § 105.66 of this chapter. CFR part 51. You may obtain copies (4) At levels not to exceed 100 IU per from the National Academy Press, 500 40 grams in meal replacement bars or Fifth St. NW., Washington, DC 20001 other-type bars that are represented (Internet address http://www.nap.edu). for special dietary use in reducing or Copies may be examined at the Center maintaining body weight in accordance for Food Safety and Applied Nutri- with § 105.66 of this chapter. tion’s Library, Food and Drug Admin- (5) At levels not to exceed 81 IU per 30 istration, 5100 Paint Branch Pkwy., grams in cheese and cheese products as College Park, MD 20740, or at the Na- defined under § 170.3(n)(5) of this chap- tional Archives and Records Adminis- ter, excluding cottage cheese, ricotta tration (NARA). For information on cheese, and hard grating cheeses such the availability of this material at as Parmesan and Romano as defined in NARA, call 202–741–6030, or go to: http:// §§ 133.165 and 133.183 of this chapter, and www.archives.gov/federallregister/ those defined by standard of identity in codeloflfederallregulations/ ibrllocations.html. § 133.148 of this chapter. (c) The additive may be used as fol- [68 FR 9003, Feb. 27, 2003, as amended at 70 lows: FR 36025, June 22, 2005; 70 FR 37257, June 29, (1) At levels not to exceed 100 Inter- 2005; 70 FR 69438, Nov. 16, 2005] national Units (IU) per 240 milliliters (mL) in 100 percent fruit juices (as de-

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§ 172.385 Whole fish protein con- scribed in section 24.003 of the AOAC. centrate. See paragraph (c)(1) of this section for The food additive whole fish protein availability of the material incor- concentrate may be safely used as a porated by reference. food supplement in accordance with (3) Fat content shall not exceed 0.5 the following prescribed conditions: percent by weight of the final product, (a) The additive is derived from as determined by the method described whole, wholesome hake and hakelike in section 24.005 of the AOAC. See para- fish, herring of the genera Clupea, men- graph (c)(1) of the this section for haden, and anchovy of the species En- availability of the material incor- graulis mordax, handled expeditiously porated by reference. and under sanitary conditions in ac- (4) The additive may contain residues cordance with good manufacturing of isopropyl alcohol and ethylene di- practices recognized as proper for fish chloride not in excess of 250 parts per that are used in other forms for human million and 5 parts per million, respec- food. tively, when used as solvents in the ex- (b) The additive consists essentially traction process. of a dried fish protein processed from (5) Microwave radiation meeting the the whole fish without removal of requirements of § 179.30 of this chapter heads, fins, tails, viscera, or intestinal may be used to reduce residues of the contents. It is prepared by solvent ex- solvents used in the extraction process. traction of fat and moisture with iso- (6) The additive shall contain not in propyl alcohol or with ethylene dichlo- excess of 100 parts per million fluorides ride followed by isopropyl alcohol, ex- (expressed as F). cept that the additive derived from (7) The additive shall be free of Esch- herring, menhaden and anchovy is pre- erichia coli and pathogenic organisms, pared by solvent extraction with iso- including Salmonella, and shall have a propyl alcohol alone. Solvent residues total bacterial plate count of not more are reduced by conventional heat dry- than 10,000 per gram. ing and/or microwave radiation and (8) The additive shall have no more there is a partial removal of bone. than a faint characteristic fish odor (c) The food additive meets the fol- and taste. lowing specifications: (1) Protein content (N × 6.25) shall (d) When the additive is used or in- not be less than 75 percent by weight of tended for use in the household as a the final product, as determined by the protein supplement in food for regular method described in section 2.057 in consumption by children up to 8 years ‘‘Official Methods of Analysis of the of age, the amount of the additive from Association of Official Analytical this source shall not exceed 20 grams Chemists’’ (AOAC), 13th Ed. (1980). Pro- per day (about one heaping table- tein quality shall not be less than 100, spoon). as determined by the method described (e) When the additive is used as a in sections 43.212–43.216 of the AOAC. protein supplement in manufactured The 13th Ed. is incorporated by ref- food, the total fluoride content (ex- erence, and copies may be obtained pressed as F) of the finished food shall from the AOAC INTERNATIONAL, 481 not exceed 8 ppm based on the dry North Frederick Ave., suite 500, Gai- weight of the food product. thersburg, MD 20877, or may be exam- (f) To assure safe use of the additive, ined at the National Archives and in addition to the other information re- Records Administration (NARA). For quired by the Act: information on the availability of this (1) The label of consumer-sized or material at NARA, call 202–741–6030, or bulk containers of the additive shall go to: http://www.archives.gov/ bear the name ‘‘whole fish protein con- federallregister/ centrate’’. codeloflfederallregulations/ (2) The label or labeling of containers ibrllocations.html. of the additive shall bear adequate di- (2) Moisture content shall not exceed rections for use to comply with the 10 percent by weight of the final prod- limitations prescribed by paragraphs uct, as determined by the method de- (d) and (e) of this section.

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(3) Labels of manufactured foods con- (a) The additive is the chemical taining the additive shall bear, in the green ferric ammonium citrate. ingredient statement, the name of the (b) The additive is used, or intended additive, ‘‘whole fish protein con- for use as an anticaking agent in salt centrate’’ in the proper order of de- for human consumption so that the creasing predominance in the finished level of iron ammonium citrate does food. not exceed 25 parts per million (0.0025 percent) in the finished salt. [42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, (c) To assure safe use of the additive 1989] the label or labeling of the additive shall bear, in addition to the other in- § 172.395 Xylitol. formation required by the Act: Xylitol may be safely used in foods (1) The name of the additive. (2) Adequate directions to provide a for special dietary uses, provided the final product that complies with the amount used is not greater than that limitations prescribed in paragraph (b) required to produce its intended effect. of this section. § 172.399 Zinc methionine sulfate. § 172.480 Silicon dioxide. Zinc methionine sulfate, CAS Reg. The food additive silicon dioxide may No. 56329–42–1, may be safely used in be safely used in food in accordance accordance with the following pre- with the following conditions: scribed conditions: (a) The food additive is manufactured (a) The additive is the product of the by vapor phase hydrolysis or by other reaction between equimolar amounts of means whereby the particle size is such zinc sulfate and DL-methionine in puri- as to accomplish the intended effect. fied water. (b) It is used as an anticaking agent, (b) The additive meets the following subject to the following conditions: specifications: (1) It is used in only those foods in Zinc content—19 to 22 percent. which the additive has been dem- C5H11NO2S ‘‘DL-methionine’’—46 to 50 per- onstrated to have an anticaking effect. cent. (2) It is used in an amount not in ex- Cadmium—not more than 0.05 part per mil- cess of that reasonably required to lion. produce its intended effect. (c) The additive is used in tablet form (3) [Reserved] as a source of dietary zinc. (4) It is used in an amount not to exceed 2 percent by weight of the food. [46 FR 58297, Dec. 1, 1981] (c) It is used or intended for use as a stabilizer in the production of beer, and Subpart E—Anticaking Agents is removed from the beer by filtration prior to final processing. § 172.410 Calcium silicate. (d) It is used or intended for use as an Calcium silicate, including synthetic adsorbent for dl-a-tocopheryl acetate calcium silicate, may be safely used in and pantothenyl alcohol in tableted food in accordance with the following foods for special dietary use, in an prescribed conditions: amount not greater than that required (a) It is used as an anticaking agent to accomplish the intended physical or in food in an amount not in excess of technical effect. that reasonably required to produce its intended effect. § 172.490 Yellow prussiate of soda. (b) It will not exceed 2 percent by (a) The food additive yellow prussiate weight of the food, except that it may of soda (sodium ferrocyanide decahy- be present up to 5 percent by weight of drate; Na4Fe(CN)6·10H2O contains a baking powder. minimum of 99 percent by weight of sodium ferrocyanide decahydrate. § 172.430 Iron ammonium citrate. (b) The additive is used or intended Iron ammonium citrate may be safe- for use as an anticaking agent in salt ly used in food in accordance with the and as an adjuvant in the production of following prescribed conditions: dendritic crystals of salt in an amount

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needed to produce its intended effect (a) They are used in the minimum but not in excess of 13 parts per million quantity required to produce their in- calculated as anhydrous sodium ferro- tended physical or technical effect and cyanide. in accordance with all the principles of [42 FR 14491, Mar. 15, 1977, as amended at 58 good manufacturing practice. FR 17098, Apr. 1, 1993] (b) In the appropriate forms (plant parts, fluid and solid extracts, con- Subpart F—Flavoring Agents and centrates, absolutes, oils, gums, bal- Related Substances sams, resins, oleoresins, waxes, and dis- tillates) they consist of one or more of § 172.510 Natural flavoring substances the following, used alone or in com- and natural substances used in con- bination with flavoring substances and junction with flavors. adjuvants generally recognized as safe Natural flavoring substances and in food, previously sanctioned for such natural adjuvants may be safely used use, or regulated in any section of this in food in accordance with the fol- part. lowing conditions.

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. 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.

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Common name Scientific name Limitations

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. 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.

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Common name Scientific name Limitations

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. 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.

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[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- Amyl heptanoate. stances and adjuvants. Amyl hexanoate. Amyl octanoate. Synthetic flavoring substances and Anisole; methoxybenzene. adjuvants may be safely used in food in Anisyl acetate. accordance with the following condi- Anisyl alcohol; p-methoxybenzyl alcohol. tions. Anisyl butyrate (a) They are used in the minimum Anisyl formate. Anisyl phenylacetate. quantity required to produce their in- Anisyl propionate. tended effect, and otherwise in accord- Beechwood creosote. ance with all the principles of good Benzaldehyde dimethyl acetal. manufacturing practice. Benzaldehyde glyceryl acetal; 2-phenyl-m-di- (b) They consist of one or more of the oxan-5-ol. following, used alone or in combination Benzaldehyde propylene glycol acetal; 4- with flavoring substances and adju- methyl-2-phenyl-m-dioxolane. vants generally recognized as safe in Benzenethiol; thiophenol. Benzoin; 2-hydroxy-2-phenylacetophenone. food, prior-sanctioned for such use, or Benzophenone; diphenylketone. regulated by an appropriate section in Benzyl acetate. this part. Benzyl acetoacetate. Benzyl alcohol. Acetal; acetaldehyde diethyl acetal. Benzyl benzoate. Acetaldehyde phenethyl propyl acetal. Benzyl butyl ether. ′ Acetanisole; 4 -methoxyacetophenone. Benzyl butyrate. Acetophenone; methyl phenyl ketone. Benzyl cinnamate. Allyl anthranilate. Benzyl 2,3–dimethylcrotonate; benzyl methyl Allyl butyrate. tiglate. Allyl cinnamate. Benzyl disulfide; dibenzyl disulfide. Allyl cyclohexaneacetate. Benzyl ethyl ether. Allyl cyclohexanebutyrate. Benzyl formate. Allyl cyclohexanehexanoate. 3-Benzyl-4-heptanone; benzyl dipropyl ke- Allyl cyclohexaneproprionate. tone. Allyl cyclohexanevalerate. Benzyl isobutyrate. Allyl disulfide. Benzyl isovalerate. Allyl 2-ethylbutyrate. Benzyl mercaptan; a-toluenethiol. Allyl hexanoate; allyl caproate. Benzyl methoxyethyl acetal; acetaldehyde Allyl a-ionone; 1-(2,6,6-trimethyl-2-cyclo-hex- benzyl b-methoxyethyl acetal. ene-1-yl)-1,6-heptadiene-3-one. Benzyl phenylacetate. Allyl isothiocyanate; mustard oil. Benzyl propionate. Allyl isovalerate. Benzyl salicylate. Allyl mercaptan; 2-propene-1-thiol. Birch tar oil. Allyl nonanoate. Borneol; d-camphanol. Allyl octanoate. Bornyl acetate. Allyl phenoxyacetate. Bornyl formate. Allyl phenylacetate. Bornyl isovalerate. Allyl propionate. Bornyl valerate. Allyl sorbate; allyl 2,4-hexadienoate. b-Bourbonene; 1,2,3,3a,3bb,4,5,6,6ab,6ba-deca- Allyl sulfide. hydro-la-isopropyl-3aa-methyl-6-meth- Allyl tiglate; allyl trans-2-methyl-2- ylene-cyclobuta [1,2:3,4] dicyclopentene. butenoate. 2-Butanol. Allyl 10-undecenoate. 2-Butanone; methyl ethyl ketone. Ammonium isovalerate. Butter acids. Ammonium sulfide. Butter esters. Amyl alcohol; pentyl alcohol. Butyl acetate. Amyl butyrate. Butyl acetoacetate. a-Amylcinnamaldehyde. Butyl alcohol; 1-butanol. a-Amylcinnamaldehyde dimethyl acetal. Butyl anthranilate. a-Amylcinnamyl acetate. Butyl butyrate. a-Amylcinnamyl alcohol. Butyl butyryllactate; lactic acid, butyl a-Amylcinnamyl formate. ester, butyrate. a-Amylcinnamyl isovalerate. a-Butylcinnamaldehyde. Amyl formate. Butyl cinnamate.

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Butyl 2-decenoate. Citronellyl valerate. Butyl ethyl malonate. p-Cresol. Butyl formate. Cuminaldehyde; cuminal; p-isopropyl benz- Butyl heptanoate. aldehyde. Butyl hexanoate. Cyclohexaneacetic acid. Butyl p-hydroxybenzoate. Cyclohexaneethyl acetate. Butyl isobutyrate. Cyclohexyl acetate. Butyl isovalerate. Cyclohexyl anthranilate. Butyl lactate. Cyclohexyl butyrate. Butyl laurate. Cyclohexyl cinnamate. Butyl levulinate. Cyclohexyl formate. Butyl phenylacetate. Cyclohexyl isovalerate. Butyl propionate. Cyclohexyl propionate. Butyl stearate. p-Cymene. Butyl sulfide. g-Decalactone; 4-hydroxy-decanoic acid, g- Butyl 10-undecenoate. lactone. Butyl valerate. g-Decalactone; 5-hydroxy-decanoic acid, d- Butyraldehyde. lactone. Cadinene. Decanal dimethyl acetal. Camphene; 2,2-dimethyl-3-methylene- 1-Decanol; decylic alcohol. norbornane. 2-Decenal. d-Camphor. 3-Decen-2-one; heptylidene acetone. Carvacrol; 2-p-cymenol. Decyl actate. Carvacryl ethyl ether; 2-ethoxy-p-cymene. Decyl butyrate. Carveol; p-mentha-6,8-dien-2-ol. Decyl propionate. 4-Carvomenthenol; 1-p-menthen-4-ol; 4- Dibenzyl ether. terpinenol. 4,4-Dibutyl-g-butyrolactone; 4,4-dibutyl-4-hy- cis Carvone oxide; 1,6-epoxy-p-menth-8-en-2- droxy-butyric acid, g-lactone. one. Dibutyl sebacate. Carvyl acetate. Diethyl malate. Carvyl propionate. Diethyl malonate; ethyl malonate. b-Caryophyllene. Diethyl sebacate. Caryophyllene alcohol. Diethyl succinate. Caryophyllene alcohol acetate. Diethyl tartrate. b-Caryophyllene oxide; 4-12,12-trimethyl-9- 2,5-Diethyltetrahydrofuran. methylene-5-oxatricylo [8.2.0.0 4,6] dode- Dihydrocarveol; 8-p-menthen-2-ol; 6-methyl- cane. 3-isopropenylcyclohexanol. Cedarwood oil alcohols. Dihydrocarvone. Cedarwood oil terpenes. Dihydrocarvyl acetate. 1,4-Cineole. m-Dimethoxybenzene. Cinnamaldehyde ethylene glycol acetal. p-Dimethoxybenzene; dimethyl hydro- Cinnamic acid. quinone. Cinnamyl acetate. 2,4-Dimethylacetophenone. Cinnamyl alcohol; 3-phenyl-2-propen-1-ol. a,a-Dimethylbenzyl isobutyrate; phenyldi- Cinnamyl benzoate. methylcarbinyl isobutyrate. Cinnamyl butyrate. 2,6-Dimethyl-5-heptenal. Cinnamyl cinnamate. 2,6-Dimethyl octanal; isodecylaldehyde. Cinnamyl formate. 3,7-Dimethyl-1-octanol; tetrahydrogeraniol. Cinnamyl isobutyrate. a,a-Dimethylphenethyl acetate; benzyl- Cinnamyl isovalerate. propyl acetate; benzyldimethylcarbinyl ac- Cinnamyl phenylacetate. etate. Cinnamyl propionate. a,a-Dimethylphenethyl alcohol; dimethyl- Citral diethyl acetal; 3,7-dimethyl-2,6-octa- benzyl carbinol. dienal diethyl acetal. a,a-Dimethylphenethyl butyrate; benzyl- Citral dimethyl acetal; 3,7-dimethyl-2,6-octa- dimethylcarbinyl butyrate. dienal dimethyl acetal. a,a-Dimethylphenethyl formate; benzyldi- Citral propylene glycol acetal. methylcarbinyl formate. Citronellal; 3,7-dimethyl-6-octenal; rhodinal. Dimethyl succinate. Citronellol; 3,7-dimethyl-6-octen-1-ol; d-cit- 1,3-Diphenyl-2-propanone; dibenzyl ketone. ronellol. delta-Dodecalactone; 5-hydroxydodecanoic Citronelloxyacetaldehyde. acid, deltalactone. Citronellyl acetate. g-Dodecalactone; 4-hydroxydodecanoic acid g- Citronellyl butyrate. lactone. Citronellyl formate. 2-Dodecenal. Citronellyl isobutyrate. Estragole. Citronellyl phenylacetate. r-Ethoxybenzaldehyde. Citronellyl propionate. Ethyl acetoacetate.

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Ethyl 2-acetyl-3-phenylpropionate; ethyl- Formic acid benzyl acetoacetate. (2-Furyl)-2-propanone; furyl acetone. Ethyl aconitate, mixed esters. 1-Furyl-2-propanone; furyl acetone. Ethyl acrylate. Fusel oil, refined (mixed amyl alcohols). Ethyl r-anisate. Geranyl acetoacetate; trans-3,7-dimethyl-2, 6- Ethyl anthranilate. octadien-1-yl acetoacetate. Ethyl benzoate. Geranyl acetone; 6,10-dimethyl-5,9- Ethyl benzoylacetate. undecadien-2-one. a-Ethylbenzyl butyrate; a-phenylpropyl bu- Geranyl benzoate. tyrate. Geranyl butyrate. Ethyl brassylate; tridecanedioic acid cyclic Geranyl formate. ethylene glycol diester; cyclo 1,13-ethyl- Geranyl hexanoate enedioxytridecan-1,13-dione. Geranyl isobutyrate. 2-Ethylbutyl acetate. Geranyl isovalerate. 2-Ethylbutyraldehyde. Geranyl phenylacetate. 2-Ethylbutyric acid. Geranyl propionate. Ethyl cinnamate. Glucose pentaacetate. Ethyl crotonate; trans-2-butenoic acid ethyl- Guaiacol; μ-methoxyphenol. ester. Guaiacyl acetate; μ-methoxyphenyl acetate. Ethyl cyclohexanepropionate. Guaiacyl phenylacetate. Ethyl decanoate. Guaiene; 1,4-dimethyl-7-isopropenyl-D9,10- 2-Ethylfuran. octahydroazulene. Ethyl 2-furanpropionate. Guaiol acetate; 1,4-dimethyl-7-(a-hydroxy- 4-Ethylguaiacol; 4-ethyl-2-methoxyphenol. isopropyl)-d9,10-octahydroazulene acetate. Ethyl heptanoate. g-Heptalactone; 4-hydroxyheptanoic acid, g- 2-Ethyl-2-heptenal; 2-ethyl-3-butylacrolein. lactone. Ethyl hexanoate. Heptanal; enanthaldehyde. Ethyl isobutyrate. Heptanal dimethyl acetal. Ethyl isovalerate. Heptanal 1,2-glyceryl acetal. Ethyl lactate. 2,3-Heptanedione; acetyl valeryl. Ethyl laurate. 3-Heptanol. Ethyl levulinate. 2-Heptanone; methyl amyl ketone. Ethyl maltol; 2-ethyl-3-hydroxy-4H-pyran-4- 3-Heptanone; ethyl butyl ketone. one. 4-Heptanone; dipropyl ketone. Ethyl 2-methylbutyrate. cis-4-Heptenal; cis-4-hepten-1-al. Ethyl myristate. Heptyl acetate. Ethyl nitrite. Heptyl alcohol; enanthic alcohol. Ethyl nonanoate. Heptyl butyrate. Ethyl 2-nonynoate; ethyl octyne carbonate. Heptyl cinnamate. Ethyl octanoate. Heptyl formate. Ethyl oleate. Heptyl isobutyrate. Ethyl phenylacetate. Heptyl octanoate. Ethyl 4-phenylbutyrate. 1-Hexadecanol; cetyl alcohol. Ethyl 3-phenylglycidate. w-6-Hexadecenlactone; 16-hydroxy-6- Ethyl 3-phenylpropionate; ethyl hydro- hexadecenoic acid, w-lactone; cinnamate. ambrettolide. Ethyl propionate. g-Hexalactone; 4-hydroxyhexanoic acid, g-lac- Ethyl pyruvate. tone; tonkalide. Ethyl salicylate. Hexanal; caproic aldehyde. Ethyl sorbate; ethyl 2,4-hexadienoate. 2,3-Hexanedione; acetyl butyryl. Ethyl tiglate; ethyl trans-2-methyl-2- Hexanoic acid; caproic acid. butenoate. 2-Hexenal. Ethyl undecanoate. 2-Hexen-1-ol. Ethyl 10-undecenoate. 3-Hexen-1-ol; leaf alcohol. Ethyl valerate. 2-Hexen-1-yl acetate. Eucalyptol; 1,8-epoxy-p-menthane; cineole. 3-Hexenyl isovalerate. Eugenyl acetate. 3-Hexenyl 2-methylbutyrate. Eugenyl benzoate. 3-Hexenyl phenylacetate; cis-3-hexenyl phen- Eugenyl formate. ylacetate. Eugenyl methyl ether; 4-allylveratrole; Hexyl acetate. methyl eugenol. 2-Hexyl-4-acetoxytetrahydrofuran. 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.

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Hexyl isovalerate. a-Isobutylphenethyl alcohol; isobutyl benzyl Hexyl 2-methylbutyrate. carbinol; 4-methyl-1-phenyl-2-pentanol. Hexyl octanoate. Isobutyl phenylacetate. Hexyl phenylacetate; n-hexyl phenylacetate. Isobutyl propionate. Hexyl propionate. Isobutyl salicylate. Hydroxycitronellal; 3,7-dimethyl-7-hydroxy- 2-Isobutylthiazole. octanal. Isobutyraldehyde. Hydroxycitronellal diethyl acetal. Isobutyric acid. Hydroxycitronellal dimethyl acetal. Isoeugenol; 2-methoxy-4-propenylphenol. Hydroxycitronellol; 3,7-dimethyl-1,7- Isoeugenyl acetate. octanediol. Isoeugenyl benzyl ether; benzyl isoeugenol. N-(4-Hydroxy-3-methoxybenzyl)-nonanamide; Isoeugenyl ethyl ether; 2-ethoxy-5-propenyl- pelargonyl vanillylamide. anisole; ethyl isoeugenol. 5-Hydroxy-4-octanone; butyroin. Isoeugenyl formate. 4-(p-Hydroxyphenyl)-2-butanone; p-hydroxy- Isoeugenyl methyl ether; 4-propenyl- benzyl acetone. veratrole; methyl isoeugenol. Indole. Isoeugenyl phenylacetate. a-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1- Isojasmone; mixture of 2-hexylidenecyclo- yl)-3-buten-2-one. pentanone and 2-hexyl-2-cyclopenten-1-one. b-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1- a-Isomethylionone; 4-(2,6,6-trimethyl-2- yl)-3-buten-2-one. cyclohexen-1-yl)-3-methyl-3-buten-2-one; methyl -ionone. a-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene- g 1-yl)-3-buten-2-one; 6-methylionone. Isopropyl acetate. Isoamyl acetate. r-Isopropylacetophenone. Isoamyl acetoacetate. Isopropyl alcohol; isopropanol. Isopropyl benzoate. Isoamyl alcohol; isopentyl alcohol; 3-methyl- -Isopropylbenzyl alcohol; cuminic alcohol; 1-butanol. r -cymen-7-ol. Isoamyl benzoate. r Isopropyl butyrate. Isoamyl butyrate. Isopropyl cinnamate. Isoamyl cinnamate. Isopropyl formate. Isoamyl formate. Isopropyl hexanoate. Isoamyl 2-furanbutyrate; a-isoamyl furfuryl- Isopropyl isobutyrate. propionate. Isopropyl isovalerate. Isoamyl 2-furanpropionate; a-isoamyl fur- r-Isopropylphenylacetaldehyde; r-cymen-7- furylacetate. carboxaldehyde. Isoamyl hexanoate. Isopropyl phenylacetate. Isoamyl isobutyrate. 3-(r-Isopropylphenyl)-propionaldehyde; r-iso- Isoamyl isovalerate. propylhydrocinnamaldehyde; cuminyl ac- Isoamyl laurate. etaldehyde. Isoamyl-2-methylbutyrate; isopentyl-2- Isopropyl propionate. methylbutyrate. Isopulegol; p-menth-8-en-3-ol. Isoamyl nonanoate. Isopulegone; p-menth-8-en-3-one. Isoamyl octanoate. Isopulegyl acetate. Isoamyl phenylacetate. Isoquinoline. Isoamyl propionate. Isovaleric acid. Isoamyl pyruvate. cis-Jasmone; 3-methyl-2-(2-pentenyl)-2-cyclo- Isoamyl salicylate. penten-1-one. Isoborneol. Lauric aldehyde; dodecanal. Isobornyl acetate. Lauryl acetate. Isobornyl formate. Lauryl alcohol; 1-dodecanol. Isobornyl isovalerate. Lepidine; 4-methylquinoline. Isobornyl propionate. Levulinic acid. Isobutyl acetate. Linalool oxide; cis- and trans-2-vinyl-2-meth- Isobutyl acetoacetate. yl-5-(1′-hydroxy-1′-methylethyl) tetra- Isobutyl alcohol. hydrofuran. Isobutyl angelate; isobutyl cis-2-methyl-2- Linalyl anthranilate; 3,7-dimethyl-1,6- butenoate. octadien-3-yl anthranilate. Isobutyl anthranilate. Linalyl benzoate. Isobutyl benzoate. Linalyl butyrate. Isobutyl butyrate. Linalyl cinnamate. Isobutyl cinnamate. Linalyl formate. Isobutyl formate. Linalyl hexanoate. Isobutyl 2-furanpropionate. Linalyl isobutyrate. Isobutyl heptanoate. Linalyl isovalerate. Isobutyl hexanoate. Linalyl octanoate. Isobutyl isobutyrate. Linalyl propionate.

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Maltol; 3-hydroxy-2-methyl-4H-pyran-4-one. Methyl-5-hepten-2-ol. Menthadienol; p-mentha-1,8(10)-dien-9-ol. 6-Methyl-5-hepten-2-one. p-Mentha-1,8-dien-7-ol; perillyl alcohol. Methyl hexanoate. Menthadienyl acetate; p-mentha-1,8(10)-dien- Methyl 2-hexanoate. 9-yl acetate. Methyl p-hydroxybenzoate; methylparaben. p-Menth-3-en-1-ol. Methyl a-ionone; 5-(2,6,6-trimethyl-2-cyclo- 1-p-Menthen-–9-yl acetate; p-menth-1-en-9-yl hexen-1-yl)-4-penten-3-one. acetate. Methyl b-ionone; 5-(2,6,6-trimethyl-1-cyclo- Menthol; 2-isopropyl-5-methylcyclohexanol. hexen-1-yl)-4-penten-3-one. Menthone; p-menthan-3-one. Methyl D-ionone; 5-(2,6,6-trimethyl-3-cyclo- Menthyl acetate; p-menth-3-yl acetate. hexen-1-yl-)-4-penten-3-one. Menthyl isovalerate; p-menth-3-yl iso- Methyl isobutyrate. valerate. 2-Methyl-3-(p-isopropylphenyl)-propionalde- o-Methoxybenzaldehyde. hyde; a-methyl-p-isopropylhydro- p-Methoxybenzaldehyde; p-anisaldehyde. cinnamaldehyde; cyclamen aldehyde. o-Methoxycinnamaldehyde. Methyl isovalerate. 2-Methoxy-4-methylphenol; 4-methyl- Methyl laurate. guaiacol; 2-methoxy-p-cresol. Methyl mercaptan; methanethiol. 4-(p-Methoxyphenyl)-2-butanone; anisyl ace- Methyl o-methoxybenzoate. tone. Methyl N-methylanthranilate; dimethyl an- 1-(4-Methoxyphenyl)-4-methyl-1-penten-3- thranilate. one; methoxystyryl isopropyl ketone. Methyl 2-methylbutyrate. 1-(p-Methoxyphenyl)-1-penten-3-one; a- Methyl-3-methylthiopropionate. methylanisylidene acetone; ethone. Methyl 4-methylvalerate. 1-(p-Methoxyphenyl)-2-propanone; Methyl myristate. anisylmethyl ketone; anisic ketone. Methyl b-naphthyl ketone; 2′-acetonaph- 2-Methoxy-4-vinylphenol; p-vinylguaiacol. thone. Methyl acetate. Methyl nonanoate. 4′-Methylacetophenone; p-methylaceto- Methyl 2-nonenoate. phenone; methyl p-tolyl ketone. Methyl 2-nonynoate; methyloctyne car- 2-Methylallyl butyrate; 2-methyl-2-propenl- bonate. yl butyrate. 2-Methyloctanal; methyl hexyl acetaldehyde. Methyl anisate. Methyl octanoate. o-Methylanisole; o-cresyl methyl ether. Methyl 2-octynoate; methyl heptine car- p-Methylanisole; p-cresyl methyl ether; p- bonate. methoxytoluene. 4-Methyl-2,3-pentanedione; acetyl iso- Methyl benzoate. butyryl. Methylbenzyl acetate, mixed o-,m-,p-. 4-Methyl-2-pentanone; methyl isobutyl ke- a-Methylbenzyl acetate; styralyl acetate. tone. a-Methylbenzyl alcohol; styralyl alcohol. b-Methylphenethyl alcohol; hydratropyl al- a-Methylbenzyl butyrate; styralyl butyrate. cohol. a-Methylbenzyl isobutyrate; styralyl iso- Methyl phenylacetate. butyrate. 3-Methyl-4-phenyl-3-butene-2-one. a-Methylbenzyl formate; styralyl formate. 2-Methyl-4-phenyl-2-butyl acetate; dimethyl- a-Methylbenzyl propionate; styralyl propio- phenylethyl carbinyl acetate. nate. 2-Methyl-4-phenyl-2-butyl isobutyrate; 2-Methyl-3-buten-2-ol. dimethylphenyl ethylcarbinyl isobutyrate. 2-Methylbutyl isovalerate. 3-Methyl-2-phenylbutyraldehyde; a-isopropyl Methyl p-tert-butylphenylacetate. phenylacetaldehyde. 2-Methylbutyraldehyde; methyl ethyl acetal- Methyl 4-phenylbutyrate. dehyde. 4-Methyl-1-phenyl-2-pentanone; benzyl iso- 3-Methylbutyraldehyde; isovaleraldehyde. butyl ketone. Methyl butyrate. Methyl 3-phenylpropionate; methyl hydro- 2-Methylbutyric acid. cinnamate. a-Methylcinnamaldehyde. Methyl propionate. p-Methylcinnamaldehyde. 3-Methyl-5-propyl-2-cyclohexen-1-one. Methyl cinnamate. Methyl sulfide. 2-Methyl-1,3-cyclohexadiene. 3-Methylthiopropionaldehyde; methional. Methylcyclopentenolone; 3-methylcyclopen- 2-Methyl-3-tolylpropionaldehyde, mixed o-, tane-1,2-dione. m-, p-. Methyl disulfide; dimethyl disulfide. 2-Methylundecanal; methyl nonyl acetal- Methyl ester of rosin, partially hydrogenated dehyde. (as defined in § 172.615); methyl Methyl 9-undecenoate. dihydroabietate. Methyl 2-undecynoate; methyl decyne car- Methyl heptanoate. bonate. 2-Methylheptanoic acid. Methyl valerate. 6-Methyl-3,5-heptadien-2-one. 2-Methylvaleric acid.

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Myrcene; 7-methyl-3-methylene-1,6-octa- Phenethyl anthranilate. diene. Phenethyl benzoate. Myristaldehyde; tetradecanal. Phenethyl butyrate. d-Neomenthol; 2-isopropyl-5-methylcyclo- Phenethyl cinnamate. hexanol. Phenethyl formate. Nerol; cis-3,7-dimethyl-2,6-octadien-1-ol. Phenethyl isobutyrate. Nerolidol; 3,7,11-trimethyl-1,6,10-dodecatrien- Phenethyl isovalerate. 3-ol. Phenethyl 2-methylbutyrate. Neryl acetate. Phenethyl phenylacetate. Neryl butyrate. Phenethyl propionate. Neryl formate. Phenethyl salicylate. Neryl isobutyrate. Phenethyl senecioate; phenethyl 3,3-di- Neryl isovalerate. methylacrylate. Neryl propionate. Phenethyl tiglate. 2,6-Nonadien-1-ol. Phenoxyacetic acid. g-Nonalactone; 4-hydroxynonanoic acid, g- 2-Phenoxyethyl isobutyrate. lactone; aldehyde C–18. Phenylacetaldehyde; a-toluic aldehyde. Nonanal; pelargonic aldehyde. Phenylacetaldehyde 2,3-butylene glycol ace- 1,3-Nonanediol acetate, mixed esters. tal. Nonanoic acid; pelargonic acid. Phenylacetaldehyde dimethyl acetal. 2-Nonanone; methylheptyl ketone. Phenylacetaldehyde glyceryl acetal. 3-Nonanon-1-yl acetate; 1-hydroxy-3- Phenylacetic acid; a-toluic acid. nonanone acetate. 4-Phenyl-2-butanol; phenylethyl methyl car- Nonyl acetate. binol. Nonyl alcohol; 1-nonanol. 4-Phenyl-3-buten-2-ol; methyl styryl car- Nonyl octanoate. binol. Nonyl isovalerate. 4-Phenyl-3-buten-2-one. Nootkatone; 5,6-dimethyl-8-isopropenyl- 4-Phenyl-2-butyl acetate; phenylethyl meth- bicyclo[4,4,0]-dec-1-en-3-one. yl carbinyl acetate. Ocimene; trans-b-ocimene; 3,7-dimethyl-1,3,6- 1-Phenyl-3-methyl-3-pentanol; phenylethyl octatriene. methyl ethyl carbinol. g-Octalactone; 4-hydroxyoctanoic acid, g-lac- 1-Phenyl-1-propanol; phenylethyl carbinol. tone. 3-Phenyl-1-propanol; hydrocinnamyl alcohol. Octanal; caprylaldehyde. 2-Phenylpropionaldehyde; hydratropalde- Octanal dimethyl acetal. hyde. 1-Octanol; octyl alcohol. 3-Phenylpropionaldehyde; hydrocinnamal- 2-Octanol. dehyde. 3-Octanol. 2-Phenylpropionalde-hyde dimethyl acetal; 2-Octanone; methyl hexyl ketone. hydratropic aldehyde dimethyl acetal. 3-Octanone; ethyl amyl ketone. 3-Phenylpropionic acid; hydrocinnamic acid. 3-Octanon-1-ol. 3-Phenylpropyl acetate. 1-Octen-3-ol; amyl vinyl carbinol. 2-Phenylpropyl butyrate. 1-Octen-3-yl acetate. 3-Phenylpropyl cinnamate. Octyl acetate. 3-Phenylpropyl formate. 3-Octyl acetate. 3-Phenylpropyl hexanoate. Octyl butyrate. 2-Phenylpropyl isobutyrate. Octyl formate. 3-Phenylpropyl isobutyrate. Octyl heptanoate. 3-Phenylpropyl isovalerate. Octyl isobutyrate. 3-Phenylpropyl propionate. Octyl isovalerate. 2-(3-Phenylpropyl)-tetrahydrofuran. Octyl octanoate. a-Pinene; 2-pinene. Octyl phenylacetate. b-Pinene; 2(10)-pinene. Octyl propionate. Pine tar oil. w-Pentadecalactone; 15-hydroxypentadeca- Pinocarveol; 2(10)-pinen-3-ol. noic acid, w-lactone; pentadecanolide; an- Piperidine. gelica lactone. Piperine. 2,3-Pentanedione; acetyl propionyl. d-Piperitone; p-menth-1-en-3-one. 2-Pentanone; methyl propyl ketone. Piperitenone; p-mentha-1,4(8)-dien-3-one. 4-Pentenoic acid. Piperitenone oxide; 1,2-epoxy-p-menth-4-(8)- 1-Penten-3-ol. en-3-one. Perillaldehyde; 4-isopropenyl-1-cyclohexene- Piperonyl acetate; heliotropyl acetate. 1-carboxaldehyde;p-mentha-1,8-dien-7-al. Piperonyl isobutyrate. 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. 64

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Polysorbate 80; polyoxyethylene (20) sorbitan Tetramethyl ethylcyclohexenone; mixture of monooleate. 5-ethyl-2,3,4,5-tetramethyl-2-cyclohexen-1- Potassium acetate. one and 5-ethyl-3,4,5,6-tetramethyl-2-cyclo- Propenylguaethol; 6-ethoxy-m-anol. hexen-1-one. Propionaldehyde. 2-Thienyl mercaptan; 2-thienylthiol. Propyl acetate. Thymol. Propyl alcohol; 1-propanol. Tolualdehyde glyceryl acetal, mixed o, m, p. p-Propyl anisole; dihydroanethole. Tolualdehydes, mixed o, m, p. Propyl benzoate. p-Tolylacetaldehyde. Propyl butyrate. o-Tolyl acetate; o-cresyl acetate. Propyl cinnamate. p-Tolyl acetate; p-cresyl acetate. Propyl disulfide. 4-(p-Tolyl)-2-butanone; p-methylbenzylace- Propyl formate. tone. Propyl 2-furanacrylate. p-Tolyl isobutyrate. Propyl heptanoate. p-Tolyl laurate. Propyl hexanoate. p-Tolyl phenylacetate. Propyl p-hydroxybenzoate; propylparaben. 2-(p-Tolyl)-propionaldehyde; p-methylhydra- 3-Propylidenephthalide. tropic aldehyde. Propyl isobutyrate. Tributyl acetylcitrate. Propyl isovalerate. 2-Tridecenal. Propyl mercaptan. 2,3-Undecadione; acetyl nonyryl. a-Propylphenethyl alcohol. g-Undecalactone; 4-hydroxyundecanoic acid Propyl phenylacetate. g-lactone; peach aldehyde; aldehyde C–14. Propyl propionate. Undecenal. Pulegone; p-menth-4(8)-en-3-one. 2-Undecanone; methyl nonyl ketone. Pyridine. 9-Undecenal; undecenoic aldehyde. Pyroligneous acid extract. 10-Undecenal. Pyruvaldehyde. Undecen-1-ol; undecylenic alcohol. Pyruvic acid. 10-Undecen-1-yl acetate. Rhodinol; 3,7-dimethyl-7-octen-1-ol; l- Undecyl alcohol. citronellol. Valeraldehyde; pentanal. Rhodinyl acetate. Valeric acid; pentanoic acid. Rhodinyl butyrate. Vanillin acetate; acetyl vanillin. Rhodinyl formate. Veratraldehyde. Rhodinyl isobutyrate. Verbenol; 2-pinen-4-ol. Rhodinyl isovalerate. Zingerone; 4-(4-hydroxy-3-methoxyphenyl)-2- Rhodinyl phenylacetate. butanone. Rhodinyl propionate. (c) D-Decalactone and D- Rum ether; ethyl oxyhydrate. dodecalactone when used separately or Salicylaldehyde. in combination in oleomargarine are Santalol, a and b. Santalyl acetate. used at levels not to exceed 10 parts per Santalyl phenylacetate. million and 20 parts per million, re- Skatole. spectively, in accordance with § 166.110 Sorbitan monostearate. of this chapter. Styrene. (d) BHA (butylated hydroxyanisole) Sucrose octaacetate. may be used as an antioxidant in fla- a-Terpinene. voring substances whereby the additive g-Terpinene. does not exceed 0.5 percent of the es- a-Terpineol; p-menth-1-en-8-ol. b-Terpineol. sential (volatile) oil content of the fla- Terpinolene; p-menth-1,4(8)-diene. voring substance. Terpinyl acetate. [42 FR 14491, Mar. 15, 1977, as amended at 42 Terpinyl anthranilate. FR 23148, May 6, 1977; 43 FR 19843, May 9, Terpinyl butyrate. 1978; 45 FR 22915, Apr. 4, 1980; 47 FR 27810, Terpinyl cinnamate. June 25, 1982; 48 FR 10812, Mar. 15, 1983; 48 FR Terpinyl formate. 51907, Nov. 15, 1983; 49 FR 5747, Feb. 15, 1984; Terpinyl isobutyrate. 50 FR 42932, Oct. 23, 1985; 54 FR 7402, Feb. 21, Terpinyl isovalerate. 1989; 61 FR 14245, Apr. 1, 1996; 69 FR 24511, Terpinyl propionate. May 4, 2004] Tetrahydrofurfuryl acetate. Tetrahydrofurfuryl alcohol. § 172.520 Cocoa with dioctyl sodium Tetrahydrofurfuryl butyrate. sulfosuccinate for manufacturing. Tetrahydrofurfuryl propionate. Tetrahydro-pseudo-ionone; 6,10-dimethyl-9- The food additive ‘‘cocoa with dioctyl undecen-2-one. sodium sulfosuccinate for manufac- Tetrahydrolinalool; 3,7-dimethyloctan-3-ol. turing,’’ conforming to § 163.117 of this

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chapter and § 172.810, is used or in- (i) A solution of the food additive sol- tended for use as a flavoring substance ids is made up in approximately 0.012 n in dry beverage mixes whereby the alkaline methyl alcohol (6 milliliters amount of dioctyl sodium sulfo- of 1 n sodium hydroxide diluted to 500 succinate does not exceed 75 parts per milliliters with methyl alcohol) to million of the finished beverage. The show an absorbance at 253 millimicrons labeling of the dry beverage mix shall of 0.6 to 0.9 per centimeter. (This ab- bear adequate directions to assure use sorbance is obtained by approximately in compliance with this section. 0.03 milligram solids permilliliter.) The ultraviolet absorption spectrum of this § 172.530 Disodium guanylate. solution exhibits the following charac- Disodium guanylate may be safely teristics: An absorption peak at 253 used as a flavor enhancer in foods, at a millimicrons; no absorption peak at 325 level not in excess of that reasonably to 330 millimicrons; the absorbance at required to produce the intended effect. 268 millimicrons does not exceed the absorbance at 272 millimicrons. § 172.535 Disodium inosinate. (ii) The boron content of the food ad- The food additive disodium inosinate ditive does not exceed 310 parts per may be safely used in food in accord- million (0.0310 percent), calculated as ance with the following prescribed con- boron. ditions: (2) The additive is manufactured (a) The food additive is the disodium from hops by a sequence of extractions salt of inosinic acid, manufactured and and fractionations, using benzene, light purified so as to contain no more than petroleum spirits, and methyl alcohol 150 parts per million of soluble barium as solvents, followed by isomerization in the compound disodium inosinate by potassium carbonate treatment. with seven and one-half molecules of Residues of solvents in the modified water of crystallization. hop extract shall not exceed 1.0 part (b) The food additive is used as a fla- per million of benzene, 1.0 part per mil- voring adjuvant in food. lion of light petroleum spirits, and 250 parts per million of methyl alcohol. § 172.540 DL-Alanine. The light petroleum spirits and ben- DL-Alanine (a racemic mixture of D- zene solvents shall comply with the and L-alanine; CAS Reg. No. 302–72–7) specifications in § 172.250 except that the boiling point range for light petro- may be safely used as a flavor enhancer ° ° for sweeteners in pickling mixtures at leum spirits is 150 F–300 F. a level not to exceed 1 percent of the (3) The additive is manufactured pickling spice that is added to the from hops by a sequence of extractions pickling brine. and fractionations, using methylene chloride, hexane, and methyl alcohol as [56 FR 6968, Feb. 21, 1991] solvents, followed by isomerization by sodium hydroxide treatment. Residues § 172.560 Modified hop extract. of the solvents in the modified hop ex- The food additive modified hop extract shall not exceed 5 parts per mil- tract may be safely used in beer in ac- lion of methylene chloride, 25 parts per cordance with the following prescribed million of hexane, and 100 parts per conditions: million of methyl alcohol. (a) The food additive is used or in- (4) The additive is manufactured tended for use as a flavoring agent in from hops by a sequence of extractions the brewing of beer. and fractionations, using benzene, light (b) The food additive is manufactured petroleum spirits, methyl alcohol, n- by one of the following processes: butyl alcohol, and ethyl acetate as sol- (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

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of n-butyl alcohol, and 1 part per mil- residue limitations as prescribed in lion of ethyl acetate. The light petro- paragraph (b)(5) of this section, and a leum spirits and benzene solvents shall boron content level not in excess of 300 comply with the specifications in parts per million (0.0300 percent), cal- § 172.250 except that the boiling point culated as boron. range for light petroleum spirits is 150 (8) The additive is manufactured °F to 300 °F. from hops as a nonisomerizable non- (5) The additive is manufactured volatile hop resin by an initial extrac- from hops by an initial extraction and tion and fractionation using one or fractionation using one or more of the more of the solvents listed in para- following solvents: Ethylene dichlo- graph (b)(5) of this section followed by ride, hexane, isopropyl alcohol, methyl a sequence of aqueous extractions and alcohol, methylene chloride, trichloro- removal of nonaqueous solvents to less ethylene, and water; followed by than 0.5 percent. The additive is added isomerization by calcium chloride or to the wort before or during cooking in magnesium chloride treatment in the manufacture of beer. ethylene dichloride, methylene chloride, or trichloroethylene and a further § 172.575 Quinine. sequence of extractions and fraction- Quinine, as the hydrochloride salt or ations using one or more of the sol- sulfate salt, may be safely used in food vents set forth in this paragraph. Resi- in accordance with the following condi- dues of the solvents in the modified tions: hop extract shall not exceed 125 parts per million of hexane; 150 parts per mil- Uses Limitations lion of ethylene dichloride, methylene In carbonated bev- Not to exceed 83 parts per million, as chloride, or trichloroethylene; or 250 erages as a flavor. quinine. Label shall bear a promi- parts per million of isopropyl alcohol nent declaration of the presence of quinine either by the use of the or methyl alcohol. word ‘‘quinine’’ in the name of the (6) The additive is manufactured article or through a separate dec- from hops by an initial extraction and laration. fractionation using one or more of the solvents listed in paragraph (b)(5) of § 172.580 Safrole-free extract of sas- this section followed by: Hydro- safras. genation using palladium as a catalyst The food additive safrole-free extract in methyl alcohol, ethyl alcohol, or of sassafras may be safely used in ac- isopropyl alcohol acidified with hydro- cordance with the following prescribed chloric or sulfuric acid; oxidation with conditions: peracetic acid; isomerization by cal- (a) The additive is the aqueous ex- cium chloride or magnesium chloride tract obtained from the root bark of treatment in ethylene dichloride, the plant Sassafras albidum (Nuttall) methylene chloride, or trichloro- Nees (Fam. Lauraceae). ethylene (alternatively, the hydro- (b) It is obtained by extracting the genation and isomerization steps may bark with dilute alcohol, first concen- be performed in reverse order); and a trating the alcoholic solution by vacu- further sequence of extractions and um distillation, then diluting the con- fractionations using one or more of the centrate with water and discarding the solvents listed in paragraph (b)(5) of oily fraction. this section. The additive shall meet (c) The purified aqueous extract is the residue limitations as prescribed in safrole-free. paragraph (b)(5) of this section. (d) It is used as a flavoring in food. (7) The additive is manufactured from hops as set forth in paragraph § 172.585 Sugar beet extract flavor (b)(6) of this section followed by reduc- base. tion with sodium borohydride in aque- Sugar beet extract flavor base may ous alkaline methyl alcohol, and a se- be safely used in food in accordance quence of extractions and fraction- with the provisions of this section. ations using one or more of the sol- (a) Sugar beet extract flavor base is vents listed in paragraph (b)(5) of this the concentrated residue of soluble section. The additive shall meet the sugar beet extractives from which

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sugar and glutamic acid have been re- (a) The additive is produced by par- covered, and which has been subjected tial hydrolysis of yeast extract (de- to ion exchange to minimize the con- rived from Saccharomyces cereviseae, centration of naturally occurring trace Saccharomyces fragilis, or Candida utilis) minerals. using the sprout portion of malt barley (b) It is used as a flavor in food. as the source of enzymes. The additive contains a maximum of 6 percent 5′ nu- § 172.590 Yeast-malt sprout extract. cleotides by weight. Yeast-malt sprout extract, as de- (b) The additive may be used as a fla- scribed in this section, may be safely vor enhancer in food at a level not in used in food in accordance with the fol- excess of that reasonably required to lowing prescribed conditions: produce the intended effect.

Subpart G—Gums, Chewing Gum Bases and Related Substances

§ 172.610 Arabinogalactan. Arabinogalactan may be safely used in food in accordance with the following conditions: (a) Arabinogalactan is a polysaccharide extracted by water from Western larch wood, having galactose units and arabinose units in the approximate ratio of six to one. (b) It is used in the following foods in the minimum quantity required to produce its intended effect as an emulsifier, stabilizer, binder, or bodying agent: Essential oils, nonnutritive sweeteners, flavor bases, nonstandardized dressings, and pudding mixes.

§ 172.615 Chewing gum base. The food additive chewing gum base may be safely used in the manufacture of chewing gum in accordance with the following prescribed conditions: (a) The food additive consists of one or more of the following substances that meet the specifications and limitations prescribed in this paragraph, used in amounts not to exceed those required to produce the intended physical or other technical effect.

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.

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

Family Genus and species

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. 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).

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

Family Genus and species

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- (1) It is a sulfated polysaccharide the ed in paragraph (a) of this section, dominant hexose units of which are ga- chewing gum base may also include lactose and anhydrogalactose. substances generally recognized as safe (2) Range of sulfate content: 20 per- in food. cent to 40 percent on a dry-weight (c) To assure safe use of the additive, basis. in addition to the other information re- (c) The food additive is used or in- quired by the act, the label and label- tended for use in the amount necessary ing of the food additive shall bear the for an emulsifier, stabilizer, or thick- name of the additive, ‘‘chewing gum ener in foods, except for those stand- base.’’ As used in this paragraph, the ardized foods that do not provide for term ‘‘chewing gum base’’ means the such use. manufactured or partially manufac- (d) To assure safe use of the additive, tured nonnutritive masticatory sub- the label and labeling of the additive stance comprised of one or more of the shall bear the name of the additive, ingredients named and so defined in carrageenan. paragraph (a) of this section. [42 FR 14491, Mar. 15, 1977, as amended at 45 § 172.623 Carrageenan with poly- FR 56051, Aug. 22, 1980; 49 FR 5747, Feb. 15, sorbate 80. 1984; 49 FR 10105, Mar. 19, 1984; 66 FR 38153, Carrageenan otherwise meeting the July 23, 2001; 66 FR 53711, Oct. 24, 2001] definition and specifications of § 172.620 (a) and (b) and salts of carrageenan § 172.620 Carrageenan. otherwise meeting the definition of The food additive carrageenan may § 172.626(a) may be safely produced with be safely used in food in accordance the use of polysorbate 80 meeting the with the following prescribed condi- specifications and requirements of tions: § 172.840 (a) and (b) in accordance with (a) The food additive is the refined the following prescribed conditions: hydrocolloid prepared by aqueous ex- (a) The polysorbate 80 is used only to traction from the following members of facilitate separation of sheeted carra- the families Gigartinaceae and Solier- geenan and salts of carrageenan from iaceae of the class Rodophyceae (red drying rolls. seaweed): (b) The carrageenan and salts of car- Chondrus crispus. rageenan contain not more than 5 per- Chondrus ocellatus. cent by weight of polysorbate 80, and Eucheuma cottonii. the final food containing the additives Eucheuma spinosum. contains polysorbate 80 in an amount Gigartina acicularis. not to exceed 500 parts per million. Gigartina pistillata. (c) The carrageenan and salts of car- Gigartina radula. rageenan so produced are used only in Gigartina stellata. producing foods in gel form and only (b) The food additive conforms to the for the purposes defined in §§ 172.620(c) following conditions: and 172.626(b), respectively.

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(d) The carrageenan and salts of car- (2) Range of sulfate content: 8 per- rageenan so produced are not used in cent to 19 percent, on a dry-weight foods for which standards of identity basis. exist unless the standards provide for (c) The food additive is used or in- the use of carrageenan, or salts of car- tended for use in the amount necessary rageenan, combined with polysorbate for an emulsifier, stabilizer, or thick- 80. ener in foods, except for those stand- (e) The carrageenan and salts of car- ardized foods that do not provide for rageenan produced in accordance with such use. this section, and foods containing the (d) To assure safe use of the additive, same, in addition to the other require- the label and labeling of the additive ments of the Act, are labeled to show shall bear the name of the additive, the presence of polysorbate 80, and the furcelleran. label or labeling of the carrageenan § 172.660 Salts of furcelleran. and salts of carrageenan so produced bear adequate directions for use. The food additive salts of furcelleran may be safely used in food in accord- § 172.626 Salts of carrageenan. ance with the following prescribed conditions: The food additive salts of carra- (a) The food additive consists of fur- geenan may be safely used in food in celleran, meeting the provisions of accordance with the following pre- § 172.655, modified by increasing the scribed conditions: concentration of one of the naturally (a) The food additive consists of car- occurring salts (ammonium, calcium, rageenan, meeting the provisions of potassium, or sodium) of furcelleran to § 172.620, modified by increasing the the level that it is the dominant salt in concentration of one of the naturally the additive. occurring salts (ammonium, calcium, (b) The food additive is used or in- potassium, or sodium) of carrageenan tended for use in the amount necessary to the level that it is the dominant salt for an emulsifier, stabilizer, or thick- in the additive. ener in foods, except for those stand- (b) The food additive is used or in- ardized foods that do not provide for tended for use in the amount necessary such use. for an emulsifier, stabilizer, or thick- (c) To assure safe use of the additive, ener in foods, except for those stand- the label and labeling of the additive ardized foods that do not provide for shall bear the name of the salt of fur- such use. celleran that dominates the mixture by (c) To assure safe use of the additive, reason of the modification, e.g., ‘‘so- the label and labeling of the additive dium furcelleran’’, ‘‘potassium furcel- shall bear the name of the salt of car- leran’’, etc. rageenan that dominates the mixture § 172.665 Gellan gum. by reason of the modification, e.g., ‘‘sodium carrageenan’’, ‘‘potassium The food additive gellan gum may be carrageenan’’, etc. safely used in food in accordance with the following prescribed conditions: § 172.655 Furcelleran. (a) The additive is a high molecular weight polysaccharide gum produced The food additive furcelleran may be from Pseudomonas elodea by a pure cul- safely used in food in accordance with ture fermentation process and purified the following prescribed conditions: by recovery with isopropyl alcohol. It (a) The food additive is the refined is composed of tetrasaccharide repeat hydrocolloid prepared by aqueous ex- units, each containing one molecule of traction of furcellaria fastigiata of the rhamnose and glucuronic acid, and two class Rodophyceae (red seaweed). molecules of glucose. The glucuronic (b) The food additive conforms to the acid is neutralized to a mixed potas- following: sium, sodium, calcium, and magnesium (1) It is a sulfated polysaccharide the salt. The polysaccharide may contain dominant hexose units of which are ga- acyl (glyceryl and acetyl) groups as the lactose and anhydrogalactose. O-glycosidically linked esters.

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(b) The strain of P. elodea is non- used in foods where standards of iden- pathogenic and nontoxic in man and tity established under section 401 of animals. the Federal Food, Drug, and Cosmetic (c) The additive is produced by a Act do not preclude such use. process that renders it free of viable (f) To assure safe use of the additive: cells of P. elodea. (1) The label of its container shall (d) The additive meets the following bear, in addition to other information specifications: required by the Federal Food, Drug, (1) Positive for gellan gum when sub- and Cosmetic Act, the name of the ad- jected to the following identification ditive and the designation ‘‘food tests: grade’’. (i) A 1-percent solution is made by (2) The label or labeling of the food hydrating 1 gram of gellan gum in 99 additive container shall bear adequate milliliters of distilled water. The mix- directions for use. ture is stirred for about 2 hours, using [55 FR 39614, Sept. 28, 1990, as amended at 57 a motorized stirrer and a propeller- FR 55445, Nov. 25, 1992; 64 FR 1758, Jan. 12, type stirring blade. A small amount of 1999] the above solution is drawn into a wide bore pipet and transferred into a solu- § 172.695 Xanthan gum. tion of 10-percent calcium chloride. A The food additive xanthan gum may tough worm-like gel will form in- be safely used in food in accordance stantly. with the following prescribed condi- (ii) To the 1-percent distilled water tions: solution prepared for identification (a) The additive is a polysaccharide test (i), 0.50 gram of sodium chloride is gum derived from Xanthomonas added. The solution is heated to 80 °C campestris by a pure-culture fermenta- with stirring, held at 80 °C for 1 tion process and purified by recovery minute, and allowed to cool to room with isopropyl alcohol. It contains D- temperature without stirring. A firm glucose, D-mannose, and D-glucuronic gel will form. acid as the dominant hexose units and (2) Residual isopropyl alcohol (IPA) is manufactured as the sodium, potas- not to exceed 0.075 percent as deter- sium, or calcium salt. mined by the procedure described in (b) The strain of Xanthomonas the Xanthan Gum monograph, the campestris is nonpathogenic and ‘‘Food Chemicals Codex,’’ 4th ed. (1996), nontoxic in man or other animals. pp. 437–438, which is incorporated by (c) The additive is produced by a reference in accordance with 5 U.S.C. process that renders it free of viable 552(a) and 1 CFR part 51. Copies are cells of Xanthomonas campestris. available from the National Academy (d) The additive meets the following Press, Box 285, 2101 Constitution Ave. specifications: NW., Washington, DC 20055 (Internet (1) Residual isopropyl alcohol not to address http://www.nap.edu), or may be exceed 750 parts per million. examined at the Center for Food Safety (2) An aqueous solution containing 1 and Applied Nutrition’s Library, Food percent of the additive and 1 percent of and Drug Administration, 5100 Paint potassium chloride stirred for 2 hours Branch Pkwy., College Park, MD 20740, has a minimum viscosity of 600 centi- or at the National Archives and poises at 75 °F, as determined by Records Administration (NARA). For Brookfield Viscometer, Model LVF (or information on the availability of this equivalent), using a No. 3 spindle at 60 material at NARA, call 202–741–6030, or r.p.m., and the ratio of viscosities at 75 go to: http://www.archives.gov/ °F and 150 °F is in the range of 1.02 to federallregister/ 1.45. codeloflfederallregulations/ (3) Positive for xanthan gum when ibrllocations.html. subjected to the following procedure: (e) The additive is used or intended for use in accordance with current good LOCUST BEAN GUM GEL TEST manufacturing practice as a stabilizer Blend on a weighing paper or in a weighing and thickener as defined in § 170.3(o)(28) pan 1.0 gram of powdered locust bean gum of this chapter. The additive may be with 1.0 gram of the powdered polysaccharide

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to be tested. Add the blend slowly (approxi- Compare the results with a curve of the op- mately 1⁄2 minute) at the point of maximum tical density versus concentration of an au- agitation to a stirred solution of 200 milli- thentic sample of pyruvic acid that has been liters of distilled water previously heated to run through the procedure starting with the 80 °C in a 400-milliliter beaker. Continue me- preparation of the hydrazone. chanical stirring until the mixture is in solu- Record the percent by weight of pyruvic tion, but stir for a minimum time of 30 min- acid in the test polysaccharide. Note ‘‘posi- utes. Do not allow the water temperature to tive’’ for xanthan gum if the sample contains drop below 60 °C. more than 1.5 percent of pyruvic acid and Set the beaker and its contents aside to ‘‘negative’’ for xanthan gum if the sample cool in the absence of agitation. Allow a contains less than 1.5 percent of pyruvic acid minimum time of 2 hours for cooling. Exam- by weight. ine the cooled beaker contents for a firm (e) The additive is used or intended rubbery gel formation after the temperature for use in accordance with good manu- ° drops below 40 C. facturing practice as a stabilizer, emul- In the event that a gel is obtained, make sifier, thickener, suspending agent, up a 1 percent solution of the polysaccharide to be tested in 200 milliliters of distilled bodying agent, or foam enhancer in water previously heated to 80 °C (omit the lo- foods for which standards of identity cust bean gum). Allow the solution to cool established under section 401 of the Act without agitation as before. Formation of a do not preclude such use. gel on cooling indicates that the sample is a (f) To assure safe use of the additive: gelling polysaccharide and not xanthan gum. (1) The label of its container shall Record the sample as ‘‘positive’’ for xan- bear, in addition to other information than gum if a firm, rubbery gel forms in the required by the Act, the name of the presence of locust bean gum but not in its additive and the designation ‘‘food absence. Record the sample as ‘‘negative’’ for grade’’. xanthan gum if no gel forms or if a soft or brittle gel forms both with locust bean gum (2) The label or labeling of the food and in a 1 percent solution of the sample additive container shall bear adequate (containing no locust bean gum). directions for use. (4) Positive for xanthan gum when subjected to the following procedure: Subpart H—Other Specific Usage Additives PYRUVIC ACID TEST § 172.710 Adjuvants for pesticide use Pipet 10 milliliters of an 0.6 percent solu- dilutions. tion of the polysaccharide in distilled water The following surfactants and related (60 milligrams of water-soluble gum) into a adjuvants may be safely added to pes- 50-milliliter flask equipped with a standard ticide use dilutions by a grower or ap- taper glass joint. Pipet in 20 milliliters of 1N hydrochloric acid. Weigh the flask. Reflux plicant prior to application to the the mixture for 3 hours. Take precautions to growing crop: avoid loss of vapor during the refluxing. Cool n-Alkyl (C8-C18) amine acetate, where the the solution to room temperature. Add dis- alkyl groups (C8-C18) are derived from coco- tilled water to make up any weight loss from nut oil, as a surfactant in emulsifier blends the flask contents. at levels not in excess of 5 percent by weight Pipet 1 milliliter of a 2,4-dinitrophenyl- of the emulsifier blends that are added to hydrazine reagent (0.5 percent in 2N hydro- herbicides for application to corn and sor- chloric acid) into a 30-milliliter separatory ghum. funnel followed by a 2-milliliter aliquot (4 Di-n-alkyl (C8-C18) dimethyl ammonium milligrams of water-soluble gum) of the chloride, where the alkyl groups (C8-C18) are polysaccharide hydrolyzate. Mix and allow derived from coconut oil, as surfactants in the reaction mixture to stand at room tem- emulsifier blends at levels not in excess of 5 perature for 5 minutes. Extract the mixture percent by weight of emulsifier blends that with 5 milliliters of ethyl acetate. Discard are added to herbicides for application to the aqueous layer. corn or sorghum. Extract the hydrazone from the ethyl ace- Diethanolamide condensate based on a tate with three 5 milliliter portions of 10 per- mixture of saturated and unsaturated soy- cent sodium carbonate solution. Dilute the bean oil fatty acids (C16-C18) as a surfactant combined sodium carbonate extracts to 100 in emulsifier blends that are added to the milliliters with additional 10 percent sodium herbicide atrazine for application to corn. carbonate in a 10-milliliter volumetric flask. Diethanolamide condensate based on Measure the optical density of the sodium stripped coconut fatty acids (C10 C18) as a carbonate solution at 375 millimicrons. surfactant in emulsifier blends that are

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added to the herbicide atrazine for applica- tional Archives and Records Adminis- tion to corn. tration (NARA). For information on a-(p-Dodecylphenyl)-omega-hydroxypoly the availability of this material at (oxyethylene) produced by the condensation NARA, call 202–741–6030, or go to: http:// of 1 mole of dodecylphenol (dodecyl group is a proplyene tetramer isomer) with an aver- www.archives.gov/federallregister/ age of 4–14 or 30–70 moles of ethylene oxide; codeloflfederallregulations/ if a blend of products is used, the average ibrllocations.html. number of moles of ethylene oxide reacted to (c) It is used in the manufacture of produce any product that is a component of sausage casings as a formulation aid as the blend shall be in the range of 4–14 or 30– defined in § 170.3(o)(14) of this chapter 70. and as a processing aid as defined in Ethylene dichloride. § 170.3(o)(24) of this chapter. Polyglyceryl phthalate ester of coconut oil fatty acids. [62 FR 26228, May 13, 1997] a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]- omega-hydroxypoly(oxyethylene) produced § 172.715 Calcium lignosulfonate. by the condensation of 1 mole of p-(1,1,3,3- Calcium lignosulfonate may be safely tetramethylbutyl) phenol with an average of used in or on food, subject to the provi- 4–14 or 30–70 moles of ethylene oxide; if a blend of products is used, the average num- sions of this section. ber of moles of ethylene oxide reacted to (a) Calcium lignosulfonate consists of produce any product that is a component of sulfonated lignin, primarily as calcium the blend shall be in the range of 4–14 or 30– and sodium salts. 70. (b) It is used in an amount not to ex- a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]- ceed that reasonably required to ac- omega-hydroxypoly(oxyethylene) produced complish the intended physical or tech- by the condensation of 1 mole of p-(1,1,3,3- nical effect when added as a dispersing tetramethylbutyl) phenol with 1 mole of agent and stabilizer in pesticides for ethylene oxide. preharvest or postharvest application Sodium acrylate and acrylamide copolymer with a minimum average molecular to bananas. weight of 10,000,000 in which 30 percent of the polymer is comprised of acrylate units and 70 § 172.720 Calcium lactobionate. percent acrylamide units, for use as a drift The food additive calcium control agent in herbicide formulations ap- lactobionate may be safely used in food plied to crops at a level not to exceed 0.5 in accordance with the following pre- ounces of the additive per acre. scribed conditions: (a) The food additive is the calcium § 172.712 1,3-Butylene glycol. salt of lactobionic acid (4-(b,D- The food additive 1,3-butylene glycol galactosido)-D-gluconic acid) produced (CAS Reg. No. 107–88–0) may be safely by the oxidation of lactose. used in food in accordance with the fol- (b) It is used or intended for use as a lowing prescribed conditions: firming agent in dry pudding mixes at (a) It is prepared by the aldol con- a level not greater than that required densation of acetaldehyde followed by to accomplish the intended effect. catalytic hydrogenation. (b) The food additive shall conform § 172.723 Epoxidized soybean oil. to the identity and specifications listed Epoxidized soybean oil may be safely in the monograph entitled ‘‘1,3-Butyl- used in accordance with the following ene Glycol’’ in the Food Chemicals prescribed conditions: Codex, 4th ed. (1996), p. 52, which is in- (a) The additive is prepared by react- corporated by reference in accordance ing soybean oil in toluene with hydro- with 5 U.S.C. 552(a) and 1 CFR part 51. gen peroxide and formic acid. Copies are available from the Office of (b) It meets the following specifica- Premarket Approval, Center for Food tions: Safety and Applied Nutrition, 5100 (1) Epoxidized soybean oil contains Paint Branch Pkwy., College Park, MD oxirane oxygen, between 7.0 and 8.0 per- 20740, or may be examined at the Cen- cent, as determined by the American ter for Food Safety and Applied Nutri- Oil Chemists’ Society (A.O.C.S.) meth- tion’s Library, Food and Drug Admin- od Cd 9–57, ‘‘Oxirane Oxygen,’’ re- istration, 5100 Paint Branch Pkwy., approved 1989, which is incorporated by College Park, MD 20740, or at the Na- reference in accordance with 5 U.S.C

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552(a) and 1 CFR part 51. Copies are § 172.725 Gibberellic acid and its po- available from the American Oil Chem- tassium salt. 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 Division of Petition Control the malting of barley in accordance (HFS–215), Center for Food Safety and with the following prescribed condi- Applied Nutrition, Food and Drug Ad- tions: ministration, 1110 Vermont Ave. NW., (a) The additives meet the following suite 1200, Washington, DC, or at the specifications: National Archives and Records Admin- (1) The gibberellic acid is produced istration (NARA). For information on by deep-culture fermentation of a suit- the availability of this material at able nutrient medium by a strain of NARA, call 202–741–6030, or go to: http:// Fusarium moniliforme or a selection of www.archives.gov/federallregister/ this culture. codeloflfederallregulations/ (2) The gibberellic acid produced is of ibrllocations.html. 80 percent purity or better. (2) The maximum iodine value is 3.0, (3) The empirical formula of as determined by A.O.C.S. method Cd gibberellic acid is represented by 1–25, ‘‘Iodine Value of Fats and Oils C19H22O6. Wijs Method,’’ revised 1993, which is in- (4) Potassium gibberellate is the po- corporated by reference in accordance tassium salt of the specified gibberellic with 5 U.S.C. 552(a) and 1 CFR part 51. acid. The availability of this incorporation (5) The potassium gibberellate is of 80 by reference is given in paragraph percent purity or better. (b)(1) of this section. (6) The gibberellic acid or potassium gibberellate may be diluted with sub- (3) The heavy metals (as Pb) content stances generally recognized as safe in cannot be more than 10 parts per mil- foods or with salts of fatty acids con- lion, as determined by the ‘‘Heavy Met- forming to § 172.863. als Test,’’ of the ‘‘Food Chemicals (b) They are used or intended for use Codex,’’ 4th ed. (1996), pp. 760–761, Meth- in the malting of barley under condi- od II (with a 2-gram sample and 20 tions whereby the amount of either or microgram of lead ion in the control), both additives present in the malt is which is incorporated by reference in not in excess of 2 parts per million ex- accordance with 5 U.S.C. 552(a) and 1 pressed as gibberellic acid, and the CFR part 51. Copies are available from treated malt is to be used in the pro- the National Academy Press, Box 285, duction of fermented malt beverages or 2101 Constitution Ave. NW., Wash- distilled spirits only, whereby the fin- ington, DC 20055 (Internet address ished distilled spirits contain none and http://www.nap.edu), or may be exam- the finished malt beverage contains ined at the Center for Food Safety and not more than 0.5 part per million of Applied Nutrition’s Library, Food and gibberellic acid. Drug Administration, 5100 Paint (c) To insure the safe use of the food Branch Pkwy., College Park, MD 20740, additives the label of the package shall or at the National Archives and bear, in addition to the other informa- Records Administration (NARA). For tion required by the Act: information on the availability of this (1) The name of the additive, material at NARA, call 202–741–6030, or ‘‘gibberellic acid’’ or ‘‘potassium go to: http://www.archives.gov/ gibberellate’’, whichever is appro- federallregister/ priate. codeloflfederallregulations/ (2) An accurate statement of the con- ibrllocations.html. centration of the additive contained in the package. (c) The additive is used as a halogen (3) Adequate use directions to provide stabilizer in brominated soybean oil at not more than 2 parts per million of a level not to exceed 1 percent. gibberellic acid in the finished malt. [60 FR 32903, June 26, 1995, as amended at 64 (4) Adequate labeling directions to FR 1759, Jan. 12, 1999] provide that the final malt is properly

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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 ° (2) ‘‘Brewer’s malt—To be used in the drop-softening point of 88 to 96 C; and production of fermented malt bev- a color of N or paler as determined in erages only’’ or ‘‘Distiller’s malt—To accordance with Official Naval Stores be used in the production of distilled Standards of the United States. It is spirits only’’, whichever is appropriate. purified by countercurrent steam distillation or steam stripping. § 172.730 Potassium bromate. (b) It is used to adjust the density of The food additive potassium bromate citrus oils used in the preparation of may be safely used in the malting of beverages whereby the amount of the barley under the following prescribed additive does not exceed 100 parts per conditions: million of the finished beverage. (a)(1) It is used or intended for use in [42 FR 14491, Mar. 15, 1977, as amended at 70 the malting of barley under conditions FR 15758, Mar. 29, 2005; 72 FR 46896, Aug. 22, whereby the amount of the additive 2007] present in the malt from the treatment does not exceed 75 parts per million of § 172.736 Glycerides and polyglycides bromate (calculated as Br), and the of hydrogenated vegetable oils. treated malt is used only in the pro- The food additive glycerides and duction of fermented malt beverages or polyglycides of hydrogenated vegetable distilled spirits. oils may be safely used in food in ac- (2) The total residue of inorganic bro- cordance with the following prescribed mides in fermented malt beverages, re- conditions: sulting from the use of the treated (a) The additive is manufactured by malt plus additional residues of inor- heating a mixture of hydrogenated oils ganic bromides that may be present from uses in accordance with other reg- of vegetable origin and polyethylene ulations in this chapter promulgated glycol in the presence of an alkaline under sections 408 and/or 409 of the act, catalyst followed by neutralization does not exceed 25 parts per million of with any acid that is approved or is bromide (calculated as Br). No toler- generally recognized as safe for this ance is established for bromide in dis- use to yield the finished product. tilled spirits because there is evidence (b) The additive consists of a mixture that inorganic bromides do not pass of mono-, di- and tri-glycerides and over in the distillation process. polyethylene glycol mono- and di- (b) To assure safe use of the additive, esters of fatty acids (polyglycides) of the label or labeling of the food addi- hydrogenated vegetable oils and meets tive shall bear, in addition to the other the following specifications: information required by the Act, the (1) Total ester content, greater than following: 90 percent as determined by a method (1) The name of the additive. entitled ‘‘Determination of Esterified (2) Adequate directions for use. Glycerides and Polyoxyethylene (c) To assure safe use of the additive, Glycols,’’ approved November 16, 2001, the label or labeling of the treated printed by Gattefosse S.A.S., and in- malt shall bear, in addition to other incorporated by reference. The Director formation required by the Act, the of the Office of the Federal Register statement, ‘‘Brewer’s Malt—To be used approves this incorporation by ref- in the production of fermented malt erence in accordance with 5 U.S.C.

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552(a) and 1 CFR part 51. You may ob- www.archives.gov/federallregister/ tain a copy from the Office of Food Ad- codeloflfederallregulations/ ditive Safety, 5100 Paint Branch Pkwy., ibrllocations.html. College Park, MD 20740 or you may ex- (4) 1,4-Dioxane, not greater than 10 amine a copy at the Center for Food milligrams per kilogram (mg/kg), and Safety and Applied Nutrition’s Li- ethylene oxide, not greater than 1 mg/ brary, Food and Drug Administration, kg, as determined by a gas 5100 Paint Branch Pkwy., College Park, chromatographic method entitled MD 20740, or at the National Archives ‘‘Determination of Ethylene Oxide and and Records Administration (NARA). 1,4-Dioxane by Headspace Gas Chroma- For information on the availability of tography,’’ approved November 5, 1998, this material at NARA, call 202–741– printed by Gattefosse S.A.S., and in- 6030, or go to http://www.archives.gov/ corporated by reference in accordance federallregister/ with 5 U.S.C. 552(a) and 1 CFR part 51; codeloflfederallregulations/ see paragraph (b)(1) of this section for ibrllocations.html. availability of the incorporation by (2) Acid value, not greater than 2, reference. and hydroxyl value, not greater than 56 (c) The additive is used or intended as determined by the methods entitled for use as an excipient in dietary sup- ‘‘Acid Value,’’ p. 934 and ‘‘Hydroxyl plement tablets, capsules, and liquid Value,’’ p. 936, respectively, in the formulations that are intended for in- Food Chemicals Codex, 5th ed., effec- gestion in daily quantities measured in tive January 1, 2004, and incorporated drops or similar small units of meas- by reference in accordance with 5 ure. U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Acad- [71 FR 12620, Mar. 13, 2006] emies Press, 500 Fifth St. NW., Wash- § 172.755 Stearyl monoglyceridyl cit- ington, DC 20055 (Internet address rate. http://www.nap.edu), or may be examined at the Center for Food Safety and The food additive stearyl Applied Nutrition’s Library, 5100 Paint monoglyceridyl citrate may be safely Branch Pkwy., College Park, MD 20740, used in food in accordance with the fol- or at the National Archives and lowing provisions: Records Administration (NARA). For (a) The additive is prepared by con- information on the availability of this trolled chemical reaction of the fol- material at NARA, call 202–741–6030, or lowing: go to http://www.archives.gov/ Reactant Limitations federallregister/ codeloflfederallregulations/ Citric acid ...... ibrllocations.html. Monoglycerides of fatty Prepared by the glycerolysis of ed- acids. ible fats and oils or derived from (3) Lead, not greater than 0.1 mg/kg fatty acids conforming with as determined by the American Oil § 172.860. Chemists’ Society (A.O.C.S.) method Stearyl alcohol...... Derived from fatty acids con- Ca 18c–91, ‘‘Determination of Lead by forming with § 172.860, or derived synthetically in conformity Direct Graphite Furnace Atomic Ab- with § 172.864. sorption Spectrophotometry,’’ updated 1995, and incorporated by reference in (b) The additive stearyl accordance with 5 U.S.C. 552(a) and 1 monoglyceridyl citrate, produced as CFR part 51. Copies are available from described under paragraph (a) of this American Oil Chemists’ Society, P. O. section, meets the following specifica- Box 3489, Champaign, IL 61826–3489, or tions: may be examined in the library at the Center for Food Safety and Applied Nu- Acid number 40 to 52. trition, 5100 Paint Branch Pkwy., Col- Total citric acid 15 to 18 percent. Saponification number 215–255. lege Park, MD 20740, or at the National Archives and Records Administration (c) The additive is used or intended (NARA). For information on the avail- for use as an emulsion stabilizer in or ability of this material at NARA, call with shortenings containing emulsi- 202–741–6030, or go to http:// fiers.

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§ 172.765 Succistearin (stearoyl pro- (c) The additive is used as a carrier of pylene glycol hydrogen succinate). vitamin B12 in foods for special dietary use. The food additive succistearin (stearoyl propylene glycol hydrogen succi- § 172.780 Acacia (gum arabic). nate) may be safely used in food in ac- The food additive may be safely used cordance with the following prescribed in food in accordance with the fol- conditions: lowing prescribed conditions: (a) The additive is the reaction prod- (a) Acacia (gum arabic) is the dried uct of succinic anhydride, fully hydro- gummy exudate from stems and genated vegetable oil (predominantly branches of trees of various species of C16 or C18 fatty acid chain length), and the genus Acacia, family Leguminosae. propylene glycol. (b) The ingredient meets the speci- (b) The additive meets the following fications of the ‘‘Food Chemicals specifications: Codex,’’ 5th Ed. (2004), pp. 210 and 211, Acid number 50–150. which is incorporated by reference. The Hydroxyl number 15–50. Director of the Office of the Federal Succinated ester content 45–75 percent. Register approves this incorporation by reference in accordance with 5 (c) The additive is used or intended U.S.C. 552(a) and 1 CFR part 51. You for use as an emulsifier in or with may obtain copies from the National shortenings and edible oils intended for Academies Press, 500 Fifth St. NW., use in cakes, cake mixes, fillings, Washington, DC 20001 (Internet ad- icings, pastries, and toppings, in ac- dress: http://www.nap.edu). Copies may cordance with good manufacturing be examined at the Center for Food practice. Safety and Applied Nutrition’s Li- brary, Food and Drug Administration, § 172.770 Ethylene oxide polymer. 5100 Paint Branch Pkwy., College Park, The polymer of ethylene oxide may MD 20740, or at the National Archives be safely used as a foam stabilizer in and Records Administration (NARA). fermented malt beverages in accord- For information on the availability of ance with the following conditions. this material at NARA, call 202–741– 6030, or go to: http://www.archives.gov/ (a) It is the polymer of ethylene federallregister/ oxide having a minimum viscosity of codeloflfederalregulations/ 1,500 centipoises in a 1 percent aqueous ibrllocations.html. ° solution at 25 C. (c) The ingredient is used as a thick- (b) It is used at a level not to exceed ener, emulsifier, or stabilizer in alco- 300 parts per million by weight of the holic beverages at a use level not to ex- fermented malt beverage. ceed 20 percent in the final beverage. (c) The label of the additive bears directions for use to insure compliance [70 FR 8034, Feb. 17, 2005] with paragraph (b) of this section. § 172.785 Listeria-specific bacteriophage preparation. § 172.775 Methacrylic acid- divinylbenzene copolymer. The additive may be safely used as an antimicrobial agent specific for Listeria Methacrylic acid-divinylbenzene co- monocytogenes (L. monocytogenes) in ac- polymer may be safely used in food in cordance with the following conditions: accordance with the following pre- (a) Identity. (1) The additive consists scribed conditions: of a mixture of equal proportions of six (a) The additive is produced by the different individually purified lytic- polymerization of methacrylic acid and type (lacking lysogenic activity) divinylbenzene. The divinylbenzene bacteriophages (phages) specific functions as a cross-linking agent and against L. monocytogenes. constitutes a minimum of 4 percent of (2) Each phage is deposited at, and the polymer. assigned an identifying code by, a sci- (b) Aqueous extractives from the ad- entifically-recognized culture collec- ditive do not exceed 2 percent (dry tion center, and is made available to basis) after 24 hours at 25 °C. FDA upon request.

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(3) The additive is produced from one than 5 hemolytic units (HU)/ml. The or more cell cultures of L. analytical method for determining monocytogenes in a safe and suitable nu- LLO entitled ‘‘Quantitation of trient medium. Listeriolysin O Levels in LMP–102TM,’’ (b) Specifications.(1) The additive dated September 27, 2004, and printed ≤ achieves a positive lytic result (OD600 by Intralytix, Inc., is incorporated by 0.06) when tested against any of the fol- reference. Copies are available at loca- lowing L. monocytogenes isolates avail- tions cited in paragraph (b)(1) of this able from American Type Culture Col- section. lection (ATCC): ATCC 35152 (serogroup (5) The additive is negative for L. 1/2a), ATCC 19118 (serogroup 4b), and monocytogenes. The modified version of ATCC 15313 (serogroup 1/2b). The ana- the U.S. Department of Agriculture’s lytical method for determining the potency of the additive entitled ‘‘Deter- method for determining L. TM mination of Potency of LMP–102TM,’’ monocytogenes entitled ‘‘LMP–102 dated October 9, 2003, and printed by Listeria monocytogenes Sterility Test- Intralytix, Inc., is incorporated by ref- ing,’’ dated May 24, 2004, and printed by erence. The Director of the Office of Intralytix, Inc., is incorporated by ref- the Federal Register approves this in- erence. Copies are available at loca- corporation by reference in accordance tions cited in paragraph (b)(1) of this with 5 U.S.C. 552(a) and 1 CFR part 51. section. You may obtain a copy from the Office (6) The additive is negative for gram- of Food Additive Safety (HFS–200), positive and gram-negative bacteria Center for Food Safety and Applied Nu- capable of growing in commonly used trition, Food and Drug Administration, microbiological media (e.g., Luria- 5100 Paint Branch Pkwy., College Park, Bertani (LB) medium), including Esch- MD 20740, or you may examine a copy erichia coli, Salmonella species and at the Center for Food Safety and Ap- coagulase-positive Staphylococci, as de- plied Nutrition’s Library, 5100 Paint termined by the ‘‘Method to Determine Branch Pkwy., College Park, MD 20740, Microbial Contamination,’’ dated July or at the National Archives and 11, 2003, and printed by Intralytix, Inc., Records Administration (NARA). For is incorporated by reference. Copies are information on the availability of this available at locations cited in para- material at NARA, call 202–741–6030, or graph (b)(1) of this section. go to: http://www.archives.gov/ federallregister/ (7) Total organic carbon (TOC) is less codeloflfederallregulations/ than or equal to 36 mg/kg. The analyt- ibrllocations.html. ical method for determining TOC enti- (2) The mean phage titer of each tled ‘‘Determination of Total Organic monophage in the additive is 1 × 109 Carbon by Automated Analyzer,’’ dated plaque forming units (PFU)/ml. The an- March 30, 2001, and printed by alytical method for determining phage Intralytix, Inc., is incorporated by ref- titer entitled ‘‘Method to Determine erence. Copies are available at loca- Lytic Activity/Phage Titer,’’ dated No- tions cited in paragraph (b)(1) of this vember 6, 2001, and printed by section. Intralytix, Inc., is incorporated by ref- (c) Conditions of use. The additive is erence. Copies are available at loca- used in accordance with current good tions cited in paragraph (b)(1) of this manufacturing practice to control L. section. monocytogenes by direct application to (3) The phages present in the prepara- meat and poultry products that comply tion must not contain a functional por- with the ready-to-eat definition in 9 tion of any of the toxin-encoding se- CFR 430.1. Current good manufacturing quences described in 40 CFR 725.421(d). practice is consistent with direct spray No sequences derived from genes en- application of the additive at a rate of coding bacterial 16S ribosomal RNA approximately 1 mL of the additive per are present in the complete genomic 500 cm2 product surface area. sequence of the phages. (4) L. monocytogenes toxin, [71 FR 47731, Aug. 18, 2006] listeriolysin O (LLO), is not greater

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Subpart I—Multipurpose Additives uses, it shall be labeled in compliance with part 105 of this chapter. § 172.800 Acesulfame potassium. [53 FR 28382, July 28, 1988, as amended at 57 Acesulfame potassium (CAS Reg. No. FR 57961, Dec. 8, 1992; 59 FR 61540, 61543, 61545, 55589–62–3), also known as acesulfame Dec. 1, 1994; 60 FR 21702, May 3, 1995; 63 FR 36362, July 6, 1998; 68 FR 75413, Dec. 31, 2003] K, may be safely used as a general-purpose sweetener and flavor enhancer in § 172.802 Acetone peroxides. foods generally, except in meat and The food additive acetone peroxides poultry, in accordance with current may be safely used in flour, and in good manufacturing practice and in an bread and rolls where standards of amount not to exceed that reasonably identity do not preclude its use, in ac- required to accomplish the intended cordance with the following prescribed technical effect in foods for which conditions: standards of identity established under (a) The additive is a mixture of section 401 of the Federal Food, Drug, monomeric and linear dimeric acetone and Cosmetic Act do not preclude such peroxide, with minor proportions of use, under the following conditions: higher polymers, manufactured by re- (a) Acesulfame potassium is the po- action of hydrogen peroxide and ace- tassium salt of 6-methyl-1,2,3- tone. oxathiazine-4(3H)-one-2,2-dioxide. (b) The additive may be mixed with (b) The additive meets the following an edible carrier to give a concentra- specifications: tion of: (1) 3 grams to 10 grams of hy- (1) Purity is not less than 99 percent drogen peroxide equivalent per 100 on a dry basis. The purity shall be de- grams of the additive, plus carrier, for termined by a method titled use in flour maturing and bleaching; or ‘‘Acesulfame Potassium Assay,’’ which (2) approximately 0.75 gram of hydro- is incorporated by reference. Copies are gen peroxide equivalent per 100 grams available from the Center for Food of the additive, plus carrier, for use in Safety and Applied Nutrition (HFS– dough conditioning. 200), Food and Drug Administration, (c) It is used or intended for use: (1) 5100 Paint Branch Pkwy., College Park, In maturing and bleaching of flour in a MD 20740, or available for inspection at quantity not more than sufficient for the National Archives and Records Ad- such effect; and (2) as a dough-condi- ministration (NARA). For information tioning agent in bread and roll produc- on the availability of this material at tion at not to exceed the quantity of NARA, call 202–741–6030, or go to: http:// hydrogen peroxide equivalent necessary for the artificial maturing ef- www.archives.gov/federallregister/ fect. codeloflfederallregulations/ (d) To insure safe use of the additive, ibrllocations.html. the label of the food additive container (2) Fluoride content is not more than and any intermediate premix thereof 30 parts per million, as determined by shall bear, in addition to the other in- method III of the Fluoride Limit Test formation required by the act: of the Food Chemicals Codex, 3d Ed. (1) The name of the additive, ‘‘ace- (1981), p. 511, which is incorporated by tone peroxides’’. reference. Copies are available from (2) The concentration of the additive the National Academy Press, 2101 Con- expressed in hydrogen peroxide equiva- stitution Ave. NW., Washington, DC lents per 100 grams. 20418, or available for inspection at the (3) Adequate use directions to provide National Archives and Records Admin- a final product that complies with the istration (NARA). For information on limitations prescribed in paragraph (c) the availability of this material at of this section. NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ § 172.804 Aspartame. codeloflfederallregulations/ The food additive aspartame may be ibrllocations.html. safely used in food in accordance with (c) If the food containing the additive good manufacturing practice as a is represented to be for special dietary sweetening agent and a flavor enhancer

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in foods for which standards of identity and Drug Administration, 5100 Paint established under section 401 of the act Branch Pkwy., College Park, MD 20740, do not preclude such use under the fol- and at the National Archives and lowing conditions: Records Administration (NARA). For (a) Aspartame is the chemical 1- information on the availability of this methyl N-L-a-aspartyl-L-phenylalanine material at NARA, call 202–741–6030, or (C14H18N2O5). go to: http://www.archives.gov/ (b) The additive meets the specifica- federallregister/ tions of the ‘‘Food Chemicals Codex,’’ codeloflfederallregulations/ 3d Ed. (1981) pp. 28–29 and First Supple- ibrllocations.html. ment p. 5, which is incorporated by ref- (d) To assure safe use of the additive, erence in accordance with 5 U.S.C. in addition to the other information re- 552(a). Copies are available from the National Academy Press, 2101 Constitu- quired by the Act: tion Ave. NW., Washington, DC 20418, (1) The principal display panel of any or may be examined at the Center for intermediate mix of the additive for Food Safety and Applied Nutrition’s manufacturing purposes shall bear a Library, Food And Drug Administra- statement of the concentration of the tion, 5100 Paint Branch Pkwy., College additive contained therein; Park, MD 20740, or at the National Ar- (2) The label of any food containing chives and Records Administration the additive shall bear, either on the (NARA). For information on the avail- principal display panel or on the infor- ability of this material at NARA, call mation panel, the following statement: 202–741–6030, or go to: http:// www.archives.gov/federallregister/ PHENYLKETONURICS: CONTAINS codeloflfederallregulations/ PHENYLALANINE ibrllocations.html. (c)(1) When aspartame is used as a The statement shall appear in the la- sugar substitute tablet for sweetening beling prominently and conspicuously hot beverages, including coffee and tea, as compared to other words, state- L-leucine may be used as a lubricant in ments, designs or devices and in bold the manufacture of such tablets at a type and on clear contrasting back- level not to exceed 3.5 percent of the ground in order to render it likely to weight of the tablet. be read and understood by the ordinary (2) When aspartame is used in baked individual under customary conditions goods and baking mixes, the amount of of purchase and use. the additive is not to exceed 0.5 percent (3) When the additive is used in a by weight of ready-to-bake products or sugar substitute for table use, its label of finished formulations prior to bak- shall bear instructions not to use in ing. Generally recognized as safe cooking or baking. (GRAS) ingredients or food additives (4) Packages of the dry, free-flowing approved for use in baked goods shall additive shall prominently display the be used in combination with aspartame sweetening equivalence in teaspoons of to ensure its functionality as a sweet- sugar. ener in the final baked product. The (e) If the food containing the additive level of aspartame used in these prod- purports to be or is represented for spe- ucts is determined by an analytical method entitled ‘‘Analytical Method cial dietary uses, it shall be labeled in for the Determination of Aspartame compliance with part 105 of this chap- and Diketopiperazine in Baked Goods ter. and Baking Mixes,’’ October 8, 1992, [39 FR 27319, July 26, 1974] which was developed by the Nutrasweet Co. Copies are available from the Office EDITORIAL NOTE: For FEDERAL REGISTER ci- of Premarket Approval (HFS–200), Cen- tations affecting § 172.804, see the List of CFR Sections Affected, which appears in the ter for Food Safety and Applied Nutri- Finding Aids section of the printed volume tion, 5100 Paint Branch Pkwy., College and at www.fdsys.gov. Park, MD 20740, or are available for inspection at the Center for Food Safety and Applied Nutrition’s Library, Food

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§ 172.806 Azodicarbonamide. minimum cloud point of 9 °C–12 °C in 10 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 0.0045 percent (45 parts per million) by (containing authorized flavoring oils) weight of the flour used, including any for use in foods for which standards of quantity of azodicarbonamide added to identity established under section 401 flour in accordance with paragraph of the Act do not preclude such use, (a)(1) of this section. provided that the weight of the addi- (b) To assure safe use of the additive: tive does not exceed the weight of the (1) The label and labeling of the addi- flavoring oils in the flavor concentrate. tive and any intermediate premix pre- (2) The additive identified in para- pared therefrom shall bear, in addition graph (a)(2) of this section is used as a to the other information required by processing aid and wetting agent in the Act, the following: combination with dioctyl sodium sulfo- (i) The name of the additive. succinate for fumaric acid as pre- (ii) A statement of the concentration scribed in § 172.810. or the strength of the additive in any (3) The additive identified in para- intermediate premixes. graph (a)(3) of this section is used: (2) The label or labeling of the food (i) As a surfactant and defoaming additive shall also bear adequate direc- agent, at levels not to exceed 0.05 per- tions for use. cent by weight, in scald baths for poultry defeathering, followed by potable § 172.808 Copolymer condensates of water rinse. The temperatures of the ethylene oxide and propylene oxide. scald baths shall be not less than 125 Copolymer condensates of ethylene °F. oxide and propylene oxide may be safe- (ii) As a foam control and rinse adju- ly used in food under the following pre- vant in hog dehairing machines at a scribed conditions: use level of not more than 5 grams per (a) The additive consists of one of the hog. following: (4) The additive identified in para- (1) a-Hydro-omega-hydroxy-poly (oxy- graph (a)(4) of this section is used as a ethylene) poly(oxypropylene)-(55–61 dough conditioner in yeast-leavened moles)poly(oxyethylene) block copoly- bakery products for which standards of mer, having a molecular weight range identity established under section 401 of 9,760–13,200 and a cloud point above of the Act do not preclude such use, 100 °C in 1 percent aqueous solution. provided that the amount of the addi- (2) a-Hydro-omega-hydroxy-poly (oxy- tive dose not exceed 0.5 percent by ethylene)poly(oxypropylene)-(53–59 weight of the flour used. moles)poly(oxyethylene)(14–16 moles) [42 FR 14491, Mar. 15, 1977, as amended at 46 block copolymer, having a molecular FR 57476, Nov. 24, 1981] weight range of 3,500–4,125 and a cloud point of 9 °C–12 °C in 10 percent aqueous § 172.809 Curdlan. solution. Curdlan may be safely used in ac- (3) a-Hydro-omega-hydroxy-poly(ox- cordance with the following conditions: yethylene)/poly(oxypropylene) (min- (a) Curdlan is a high molecular imum 15 moles)/poly(oxyethylene) weight polymer of glucose (b-1,3- block copolymer, having a minimum glucan; CAS Reg. No. 54724–00–4) pro- average molecular weight of 1900 and a duced by pure culture fermentation

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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] (b) Curdlan meets the following specifications when it is tested according § 172.810 Dioctyl sodium sulfosuc- to the methods described or referenced cinate. in the document entitled ‘‘Analytical The food additive dioctyl sodium Methods for Specification Tests for sulfosuccinate, which meets the speci- Curdlan,’’ by Takeda Chemical Indus- fications of the Food Chemicals Codex, tries, Ltd., 12–10 Nihonbashi, 2–Chome, 3d Ed. (1981), pp. 102–104, which is incor- Chuo-ku, Tokyo, 103, Japan, 1996, which porated by reference (Copies may be is incorporated by reference in accord- obtained from the National Academy ance with 5 U.S.C. 552(a) and 1 CFR Press, 2101 Constitution Ave. NW., part 51. Copies are available from the Washington, DC 20418, or may be exam- Division of Petition Control (HFS–215), ined at the National Archives and Center for Food Safety and Applied Nu- Records Administration (NARA). For trition, Food and Drug Administration, information on the availability of this 5100 Paint Branch Pkwy., College Park, material at NARA, call 202–741–6030, or MD 20740, or may be examined at the go to: http://www.archives.gov/ Center for Food Safety and Applied Nu- federallregister/ trition’s Library, Food and Drug Ad- codeloflfederallregulations/ ministration, 5100 Paint Branch Pkwy., ibrllocations.html.), may be safely used College Park, MD 20740, or at the Na- in food in accordance with the fol- tional Archives and Records Adminis- lowing prescribed conditions: tration (NARA). For information on (a) As a wetting agent in the fol- the availability of this material at lowing fumaric acid-acidulated foods: NARA, call 202–741–6030, or go to: http:// Dry gelatin dessert, dry beverage base, www.archives.gov/federallregister/ and fruit juice drinks, when standards codeloflfederallregulations/ of identity do not preclude such use. ibrllocations.html. The labeling of the dry gelatin dessert (1) Positive for curdlan. and dry beverage base shall bear ade- (2) Assay for curdlan (calculated as quate directions for use, and the addi- anhydrous glucose), not less than 80 tive shall be used in such an amount percent. that the finished gelatin dessert will (3) pH of 1 percent aqueous suspen- contain not in excess of 15 parts per sion, 6.0–7.5. million of the additive and the finished (4) Lead, not more than 0.5 mg/kg. beverage or fruit juice drink will con- (5) Heavy metals (as Pb), not more tain not in excess of 10 parts per mil- than 0.002 percent. lion of the additive. (b) As a processing aid in sugar fac- (6) Total nitrogen, not more than 0.2 tories in the production of unrefined percent. cane sugar, in an amount not in excess (7) Loss on drying, not more than 10 of 0.5 part per million of the additive percent. per percentage point of sucrose in the (8) Residue on ignition, not more juice, syrup, or massecuite being proc- than 6 percent. essed, and so used that the final molas- (9) Gel strength of 2 percent aqueous ses will contain no more than 25 parts suspension, not less than 600×103 dyne per million of the additive. per square centimeter. (c) As a solubilizing agent on gums (10) Aerobic plate count, not more and hydrophilic colloids to be used in than 103 per gram. food as stabilizing and thickening (11) Coliform bacteria, not more than agents, when standards of identity do 3 per gram. not preclude such use. The additive is (c) Curdlan is used or intended for used in an amount not to exceed 0.5 use in accordance with good manufac- percent by weight of the gums or hy- turing practice as a formulation aid, drophilic colloids. processing aid, stabilizer and thick- (d) As an emulsifying agent for cocoa ener, and texturizer in foods for which fat in noncarbonated beverages con- standards of identity established under taining cocoa, whereby the amount of

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the additive does not exceed 25 parts Uses Limitations per million of the finished beverage. 1. As a crystallization accel- Not to exceed 1 percent of (e) As a dispersing agent in ‘‘cocoa 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. provisions of § 163.117 of this chapter 2. As a formulation aid as de- Not to exceed 0.5 percent. fined in § 170.3(o)(14) of this and the use limitations prescribed in chapter, lubricant and release § 172.520, in an amount not to exceed 0.4 agent as defined in percent by weight thereof. § 170.3(o)(18) of this chapter, and surface-finishing agent as (f) As a processing aid and wetting defined in § 170.3(o)(30) of agent in combination with a-hydro- this chapter in food. omega -hydroxy - poly(oxyethylene) - 3. As a formulation aid as de- Not to exceed 3.0 percent poly-(oxypropylene) (53–59 moles) fined in § 170.3(o)(14) of this of the combined weight chapter in confections. of the formulation. poly(oxyethylene) (14–16 moles) block 4. As a formulation aid as de- Not to exceed 1.0 percent copolymer, having a molecular weight fined in § 170.3(o)(14) of this of the combined weight range of 3,500–4,125 and a cloud point of chapter in fats and oils as de- of the formulation. ° ° fined in § 170.3 (n)(12) of this 9 C–12 C in 10 percent aqueous solu- chapter. tion, for fumaric acid used in fumaric 5. As a winterization and frac- Not to exceed 0.5 percent acid-acidulated dry beverage base and tionation aid in fat and oil by weight of the proc- in fumaric acid-acidulated fruit juice processing. essed fat or oil. drinks, when standards of identity do not preclude such use. The labeling of (d) To assure safe use of the additive: the dry beverage base shall bear ade- (1) In addition to the other informa- quate directions for use, and the addition required by the act, the label or tives shall be used in such an amount labeling of the additive shall bear the that the finished beverage or fruit juice name of the additive. drink will contain not in excess of a (2) The label of the additive shall total of 10 parts per million of the bear adequate directions to provide a dioctyl sodium sulfosuccinate-block final product that complies with the copolymer combination. limitations prescribed in paragraph (c) [42 FR 14491, Mar. 15, 1977, as amended at 49 of this section. FR 10105, Mar. 19, 1984] [53 FR 21632, June 9, 1988, as amended at 59 FR 24924, May 13, 1994] § 172.811 Glyceryl tristearate. The food additive glyceryl tristearate § 172.812 Glycine. may be safely used in food in accord- The food additive glycine may be ance with the following prescribed con- safely used for technological purposes ditions: in food in accordance with the fol- (a) The food additive (CAS Reg. No. lowing prescribed conditions: 555–43–1) is prepared by reacting stearic (a) The additive complies with the acid with glycerol in the presence of a specifications of the ‘‘Food Chemicals suitable catalyst. Codex,’’ 3d Ed. (1981), p. 140, which is in- (b) The food additive meets the fol- corporated by reference. Copies may be lowing specifications: obtained from the National Academy Acid number: Not to exceed 1.0. Press, 2101 Constitution Ave. NW., Iodine number: Not to exceed 1.0. Washington, DC 20418, or may be exam- Saponification number: 186–192. ined at the National Archives and Hydroxyl number: Not to exceed 5.0. Records Administration (NARA). For Free glycerol content: Not to exceed 0.5 per- information on the availability of this cent. material at NARA, call 202–741–6030, or Unsaponifiable matter: Not to exceed 0.5 per- go to: http://www.archives.gov/ cent. federal register/ Melting point (Class II): 69 °C–73 °C. l codeloflfederallregulations/ (c) The additive is used or intended ibrllocations.html. for use as follows when standards of (b) The additive is used or intended identity established under section 401 for use as follows: of the Act do not preclude such use:

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Uses Limitations § 172.816 Methyl glucoside-coconut oil ester. As a masking agent for the Not to exceed 0.2 percent in bitter aftertaste of sac- the finished beverage. Methyl glucoside-coconut oil ester charin used in manufac- may be safely used in food in accord- tured beverages and bev- ance with the following conditions: erage bases. As a stabilizer in mono- and Not to exceed 0.02 percent of (a) It is the methyl glucoside-coconut diglycerides prepared by the mono- and oil ester having the following specifica- the glycerolysis of edible diglycerides. tions: fats or oils. Acid number: 10–20 (c) To assure safe use of the additive, Hydroxyl number: 200–300 in addition to the other information re- pH (5% aqueous): 4.8–5.0 Saponification number: 178–190 quired by the Act: (1) The labeling of the additive shall (b) It is used or intended for use as bear adequate directions for use of the follows: additive in compliance with the provi- (1) As an aid in crystallization of su- sions of this section. crose and dextrose at a level not to exceed the minimum quantity required to (2) The labeling of beverage bases produce its intended effect. containing the additive shall bear ade- (2) As a surfactant in molasses at a quate directions for use to provide that level not to exceed 320 parts per million beverages prepared therefrom shall in the molasses. contain no more than 0.2 percent glycine. § 172.818 Oxystearin. [42 FR 14491, Mar. 15, 1977, as amended at 49 The food additive oxystearin may be FR 10105, Mar. 19, 1984] safely used in foods, when such use is not precluded by standards of identity § 172.814 Hydroxylated lecithin. in accordance with the following condi- The food additive hydroxylated tions: (a) The additive is a mixture of the lecithin may be safely used as an emul- glycerides of partially oxidized stearic sifier in foods in accordance with the and other fatty acids obtained by heat- following conditions: ing hydrogenated cottonseed or soy- (a) The additive is obtained by the bean oil under controlled conditions, in treatment of lecithin in one of the fol- the presence of air and a suitable cata- lowing ways, under controlled condi- lyst which is not a food additive as so tions whereby the separated fatty acid defined. The resultant product meets fraction of the resultant product has the following specifications: an acetyl value of 30 to 38: Acid number: Maximum 15. (1) With hydrogen peroxide, benzoyl Iodine number: Maximum 15. peroxide, lactic acid, and sodium hy- Saponification number: 225–240. droxide. Hydroxyl number: 30–45. (2) With hydrogen peroxide, acetic Unsaponifiable material: Maximum 0.8 per- acid, and sodium hydroxide. cent. Refractive index (butyro): 60±1 at 48 °C. (b) It is used or intended for use, in accordance with good manufacturing (b) It is used or intended for use as a practice, as an emulsifier in foods, ex- crystallization inhibitor in vegetable cept for those standardized foods that oils and as a release agent in vegetable do not provide for such use. oils and vegetable shortenings, where- (c) To assure safe use of the additive, by the additive does not exceed 0.125 the label of the food additive container percent of the combined weight of the oil or shortening. shall bear, in addition to the other in- (c) To insure safe use of the additive, formation required by the Act: the label and labeling of the additive (1) The name of the additive, container shall bear, in addition to the ‘‘hydroxylated lecithin’’. other information required by the Act: (2) Adequate directions for its use. (1) The name of the additive. (2) Adequate directions to provide an oil or shortening that complies with

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the limitations prescribed in paragraph SX850, or equivalent) 12 percent in H2O by (b) of this section. weight on 60–80 mesh nonacid washed diato- maceous earth (Chromosorb W. Johns-Man- § 172.820 Polyethylene glycol (mean ville, or equivalent). molecular weight 200–9,500). REAGENTS AND MATERIALS Polyethylene glycol identified in this Carrier gas, nitrogen: Commercial grade in section may be safely used in food in cylinder equipped with reducing regulator to accordance with the following pre- provide 50 p.s.i.g. to the gas chromatograph. scribed conditions: Ethylene glycol: Commercial grade. Purify (a) Identity. (1) The additive is an ad- if necessary, by distillation. dition polymer of ethylene oxide and Diethylene glycol: Commercial grade. Pu- water with a mean molecular weight of rify, if necessary, by distillation. 200 to 9,500. Glycol standards: Prepare (2) It contains no more than 0.2 per- chromatographic standards by dissolving known amounts of ethylene glycol and cent total by weight of ethylene and diethylene glycol in water. Suitable con- diethylene glycols when tested by the centrations for standardization range from 1 analytical methods prescribed in para- to 6 milligrams of each component per milli- graph (b) of this section. liter (for example 10 milligrams diluted to (b) Analytical method. (1) The analyt- volume in a 10-milliliter volumetric flask is ical method prescribed in the National equivalent to 1 milligram per milliliter). Formulary XV (1980), page 1244, for pol- STANDARDIZATION yethylene glycol 400 shall be used to determine the total ethylene and Inject a 2-microliter aliquot of the glycol diethylene glycol content of poly- standard into the gas chromatograph employing the conditions described above. ethylene glycols having mean molec- Measure the net peak heights for the ethyl- ular weights of 450 or higher. ene glycol and for the diethylene glycol. (2) The following analytical method Record the values as follows: shall be used to determine the total A=Peak height in millimeters of the ethyl- ethylene and diethylene glycol content ene glycol peak. of polyethylene glycols having mean B=milligrams of ethylene glycol per milli- molecular weights below 450. liter of standard solution. C=Peak height in millimeters of the diethylene glycol peak. ANALYTICAL METHOD D=Milligrams of diethylene glycol per milliliter of standard solution. ETHYLENE GLYCOL AND DIETHYLENE GLYCOL CONTENT OF POLYETHYLENE GLYCOLS PROCEDURE The analytical method for determining Weigh approximately 4 grams of polyethylene glycol and diethylene glycol is as ethylene glycol sample accurately into a 10- follows: milliliter volumetric flask. Dilute to volume with water. Mix the solution thoroughly and APPARATUS inject a 2-microliter aliquot into the gas Gas chromatograph with hydrogen flame chromatograph. Measure the heights, in mil- ionization detector (Varian Aerograph 600 D limeters, of the ethylene glycol peak and of or equivalent). The following conditions the diethylene glycol peak and record as E shall be employed with the Varian and F, respectively. Aerograph 600 D gas chromatograph: × × Column temperature: 165 °C. Percent ethylene glycol=(E B)/(A sample Inlet temperature: 260 °C. weight in grams) Carrier gas (nitrogen) flow rate: 70 milli- Percent diethylene glycol=(F×D)/(C×sample liters per minute. weight in grams) Hydrogen and air flow to burner: Optimize to give maximum sensitivity. (c) Uses. It may be used, except in Sample size: 2 microliters. milk or preparations intended for addi- Elution time: Ethylene glycol: 2.0 minutes. tion to milk, as follows: Diethylene glycol: 6.5 minutes. (1) As a coating, binder, plasticizing Recorder: ¥0.5 to +1.05 millivolt, full span, agent, and/or lubricant in tablets used 1 second full response time. for food. Syringe: 10-microliter (Hamilton 710 N or equivalent). (2) As an adjuvant to improve flavor Chromatograph column: 5 feet × 1⁄8 inch. and as a bodying agent in nonnutritive I.D. stainless steel tube packed with sorbitol sweeteners identified in § 180.37 of this (Mathieson-Coleman-Bell 2768 Sorbitol chapter.

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(3) As an adjuvant in dispersing vita- step is followed by a conventional re- min and/or mineral preparations. fining process that includes alkali neu- (4) As a coating on sodium nitrite to tralization and deodorization of the inhibit hygroscopic properties. fats and oils. (d) Limitations. (1) It is used in an (c) To insure the safe use of the addi- amount not greater than that required tive, the label of the food additive con- to produce the intended physical or tainer shall bear, in addition to the technical effect. other information required by the Act: (2) A tolerance of zero is established (1) The name of the additive, sodium for residues of polyethylene glycol in lauryl sulfate. milk. (2) Adequate use directions to provide [42 FR 14491, Mar. 15, 1977, as amended at 49 a final product that complies with the FR 10105, Mar. 19, 1984] limitations prescribed in paragraph (b) of this section. § 172.822 Sodium lauryl sulfate. The food additive sodium lauryl sul- [42 FR 14491, Mar. 15, 1977, as amended at 43 fate may be safely used in food in ac- FR 18668, May 2, 1978] cordance with the following conditions: (a) The additive meets the following § 172.824 Sodium mono- and dimethyl naphthalene sulfonates. specifications: (1) It is a mixture of sodium alkyl The food additive sodium mono- and sulfates consisting chiefly of sodium dimethyl naphthalene sulfonates may lauryl sulfate [CH2(CH2)10CH2OSO2Na]. be safely used in accordance with the (2) It has a minimum content of 90 following prescribed conditions: percent sodium alkyl sulfates. (a) The additive has a molecular (b) It is used or intended for use: weight range of 245–260. (1) As an emulsifier in or with egg (b) The additive is used or intended whites whereby the additive does not for use: exceed the following limits: (1) In the crystallization of sodium Egg white solids, 1,000 parts per million. carbonate in an amount not to exceed Frozen egg whites, 125 parts per million. 250 parts per million of the sodium car- Liquid egg whites, 125 parts per million. bonate. Such sodium carbonate is used (2) As a whipping agent at a level not or intended for use in potable water to exceed 0.5 percent by weight of gela- systems to reduce hardness and aid in tine used in the preparation of marsh- sedimentation and coagulation by rais- mallows. ing the pH for the efficient utilization (3) As a surfactant in: of other coagulation materials. (i) Fumaric acid-acidulated dry bev- (2) As an anticaking agent in sodium erage base whereby the additive does nitrite at a level not in excess of 0.1 not exceed 25 parts per million of the percent by weight thereof for author- finished beverage and such beverage ized uses in cured fish and meat. base is not for use in a food for which (c) In addition to the general labeling a standard of identity established requirements of the Act: under section 401 of the Act precludes (1) Sodium carbonate produced in ac- such use. cordance with paragraph (b)(1) of this (ii) Fumaric acid-acidulated fruit section shall be labeled to show the juice drinks whereby the additive does presence of the additive and its label or not exceed 25 parts per million of the labeling shall bear adequate directions finished fruit juice drink and it is not for use. used in a fruit juice drink for which a (2) Sodium nitrite produced in ac- standard of identity established under cordance with paragraph (b)(2) of this section 401 of the Act precludes such section shall bear the labeling required use. by § 172.175 and a statement declaring (4) As a wetting agent at a level not the presence of sodium mono- and di- to exceed 10 parts per million in the partition of high and low melting frac- methyl naphthalene sulfonates. tions of crude vegetable oils and ani- [42 FR 14491, Mar. 15, 1977, as amended at 63 mal fats, provided that the partition FR 7069, Feb. 12, 1998]

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§ 172.826 Sodium stearyl fumarate. essing, food-packing, or food-storage Sodium stearyl fumarate may be equipment. safely used in food in accordance with [42 FR 14491, Mar. 15, 1977, as amended at 50 the following conditions: FR 3508, Jan. 25, 1985] (a) It contains not less than 99 percent sodium stearyl fumarate cal- § 172.829 Neotame. culated on the anhydrous basis, and (a) Neotame is the chemical N-[N- not more than 0.25 percent sodium ste- (3,3-dimethylbutyl)-L-a-aspartyl]-L- aryl maleate. phenylalanine-1-methyl ester (CAS (b) The additive is used or intended Reg. No. 165450–17–9). for use: (1) As a dough conditioner in yeast- (b) Neotame meets the following leavened bakery products in an amount specifications when it is tested accord- not to exceed 0.5 percent by weight of ing to the methods described or ref- the flour used. erenced in the document entitled (2) As a conditioning agent in dehy- ‘‘Specifications and Analytical Meth- drated potatoes in an amount not to ods for Neotame’’ dated April 3, 2001, exceed 1 percent by weight thereof. by the NutraSweet Co., 699 North (3) As a stabilizing agent in Wheeling Rd., Mount Prospect, IL nonyeast-leavened bakery products in 60056. The Director of the Office of the an amount not to exceed 1 percent by Federal Register has approved the in- weight of the flour used. corporation by reference of this mate- (4) As a conditioning agent in proc- rial in accordance with 5 U.S.C. 552(a) essed cereals for cooking in an amount and 1 CFR part 51. Copies are available not to exceed 1 percent by weight of from the Office of Food Additive Safety the dry cereal, except for foods for (HFS–200), Center for Food Safety and which standards of identity preclude Applied Nutrition, 5100 Paint Branch such use. Pkwy., College Park, MD 20740. Copies (5) As a conditioning agent in starch- may be examined at the Center for thickened or flour-thickened foods in Food Safety and Applied Nutrition’s an amount not to exceed 0.2 percent by Library, 5100 Paint Branch Pkwy., rm. weight of the food. 1C–100, College Park, MD 20740, or at the National Archives and Records Ad- § 172.828 Acetylated monoglycerides. ministration (NARA). For information The food additive acetylated on the availability of this material at monoglycerides may be safely used in NARA, call 202–741–6030, or go to: http:// or on food in accordance with the fol- www.archives.gov/federallregister/ lowing prescribed conditions: codeloflfederallregulations/ (a) The additive is manufactured by: ibrllocations.html. (1) The interesterification of edible (1) Assay for neotame, not less than fats with triacetin and in the presence 97.0 percent and not more than 102.0 of catalytic agents that are not food percent on a dry basis. additives or are authorized by regula- (2) Free dipeptide acid (N-[N-(3,3- tion, followed by a molecular distilla- dimethylbutyl)-L-a-aspartyl]-L- tion or by steam stripping; or phenylalanine), not more than 1.5 per- (2) The direct acetylation of edible cent. monoglycerides with acetic anhydride (3) Other related substances, not without the use of catalyst or molec- more than 2.0 percent. ular distillation, and with the removal (4) Lead, not more than 2.0 milli- by vacuum distillation, if necessary, of the acetic acid, acetic anhydride, and grams per kilogram. triacetin. (5) Water, not more than 5.0 percent. (b) The food additive has a Reichert- (6) Residue on ignition, not more Meissl value of 75–200 and an acid value than 0.2 percent of less than 6. (7) Specific rotation, determined at (c) The food additive is used at a 20 °C [a]D: ¥40.0° to 43.4° calculated on level not in excess of the amount rea- a dry basis. sonably required to produce its in- (c) The food additive neotame may be tended effect in food, or in food-proc- safely used as a sweetening agent and

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flavor enhancer in foods generally, ex- (b) The additive meets the specifica- cept in meat and poultry, in accord- tions of the ‘‘Food Chemicals Codex,’’ ance with current good manufacturing 4th ed. (1996), pp. 398–400, which is in- practice, in an amount not to exceed corporated by reference in accordance that reasonably required to accomplish with 5 U.S.C. 552(a) and 1 CFR part 51. the intended technical effect, in foods Copies are available from the Division for which standards of identity estab- of Product Policy (HFS–206), Center for lished under section 401 of the Federal Food Safety and Applied Nutrition, Food, Drug, and Cosmetic Act do not Food and Drug Administration, 5100 preclude such use. Paint Branch Pkwy., College Park, MD (d) When neotame is used as a sugar 20740, or may be examined at the Cen- substitute tablet, L-leucine may be ter for Food Safety and Applied Nutri- used as a lubricant in the manufacture tion’s Library, 5100 Paint Branch of tablets at a level not to exceed 3.5 Pkwy., College Park, MD 20740, or at percent of the weight of the tablet. the National Archives and Records Ad- (e) If the food containing the additive ministration (NARA). For information purports to be or is represented to be on the availability of this material at for special dietary use, it shall be la- NARA, call 202–741–6030, or go to: http:// beled in compliance with part 105 of www.archives.gov/federallregister/ this chapter. codeloflfederallregulations/ [67 FR 45310, July 9, 2002] ibrllocations.html. (c) The additive may be used as a § 172.830 Succinylated monoglycerides. sweetener in foods generally, in accord- The food additive succinylated ance with current good manufacturing monoglycerides may be safely used in practice in an amount not to exceed food in accordance with the following that reasonably required to accomplish prescribed conditions: the intended effect. (a) The additive is a mixture of semi- (d) If the food containing the additive and neutral succinic acid esters of purports to be or is represented to be mono- and diglycerides produced by the for special dietary use, it shall be la- succinylation of a product obtained by beled in compliance with part 105 of the glycerolysis of edible fats and oils, this chapter. or by the direct esterification of glyc- [63 FR 16433, Apr. 3, 1998, as amended at 64 erol with edible fat-forming fatty FR 43909, Aug. 12, 1999] acids. (b) The additive meets the following § 172.832 Monoglyceride citrate. specifications: A food additive that is a mixture of Succinic acid content: 14.8%–25.6% glyceryl monooleate and its citric acid Melting point: 50 °C–60 °C. monoester manufactured by the reac- Acid number: 70–120 tion of glyceryl monooleate with citric (c) The additive is used or intended acid under controlled conditions may for use in the following foods: be safely used as a synergist and solu- (1) As an emulsifier in liquid and bilizer for antioxidants in oils and fats, plastic shortenings at a level not to ex- when used in accordance with the con- ceed 3 percent by weight of the short- ditions prescribed in this section. ening. (a) The food additive meets the fol- (2) As a dough conditioner in bread lowing specifications: baking, when such use is permitted by an appropriate food standard, at a level Acid number, 70–100. not to exceed 0.5 percent by weight of Total citric acid (free and combined), 14 percent–17 percent. the flour used. (b) It is used, or intended for use, in § 172.831 Sucralose. antioxidant formulations for addition (a) Sucralose is the chemical 1,6- 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- the combined weight of the oil or fat galactopyranoside (CAS Reg. No. 56038– and the additive. 13–2). (c) To assure safe use of the additive:

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(1) The container label shall bear, in codeloflfederallregulations/ addition to the other information re- ibrllocations.html. quired by the Act, the name of the ad- (3) Acid value: Not to exceed 0.20 de- ditive. termined using 50 grams of sample by (2) The label or accompanying label- the ‘‘Guide to Specifications for Gen- ing shall bear adequate directions for eral Notices, General Analytical Tech- the use of the additive which, if fol- niques, Identification Tests, Test Solu- lowed, will result in a food that com- tions, and Other Reference Materials,’’ plies with the requirements of this sec- in the ‘‘Compendium of Food Additive tion. Specifications, Addendum 4, FAO Food and Nutrition Paper 5, Revision 2,’’ p. § 172.833 Sucrose acetate isobutyrate 189 (1991), which is incorporated by ref- (SAIB). erence; see paragraph (b)(2) of this sec- Sucrose acetate isobutyrate may be tion for availability of the incorpora- safely used in foods in accordance with tion by reference. the following prescribed conditions: (4) Lead: Not to exceed 1.0 milli- (a) Sucrose acetate isobutyrate (CAS grams/kilogram determined by the Reg. No. 27216–37–1), or SAIB, is the ‘‘Atomic Absorption chemical alpha-D-glucopyranoside, O- Spectrophotometric Graphite Furnace acetyl-tris-O-(2-methyl-1-oxopropyl)- Method, Method I,’’ in the ‘‘Food beta-D-fructofuranosyl, acetate tris(2- Chemicals Codex,’’ 4th ed. (1996), pp. 763 methyl propanoate). and 764, with an attached modification (b) SAIB, a pale, straw-colored liquid, to the sample digestion section in Ap- meets the following specifications: (1) pendix III.B (July 1996), which is incor- Assay: Not less than 98.8 percent and porated by reference. Copies are avail- not more than 101.9 percent, based on able from the National Academy Press, the following formula: 2101 Constitution Ave. NW., Box 285, Washington, DC 20055 (Internet http:// Assay = ((SV 0.10586) ÷ 56.1) × 100 www.nap.edu), or may be examined at the Center for Food Safety and Applied Where SV = Saponification value Nutrition’s Library, 5100 Paint Branch (2) Saponification value: 524–540 de- Pkwy., College Park, MD 20740, or at termined using 1 gram of sample by the the National Archives and Records Ad- ‘‘Guide to Specifications for General ministration (NARA). For information Notices, General Analytical Tech- on the availability of this material at niques, Identification Tests, Test Solu- NARA, call 202–741–6030, or go to: http:// tions, and Other Reference Materials,’’ www.archives.gov/federallregister/ in the ‘‘Compendium of Food Additive codeloflfederallregulations/ Specifications, Addendum 4, Food and ibrllocations.html. Agriculture Organization of the United (5) Triacetin: Not to exceed 0.10 per- Nations (FAO), Food and Nutrition cent determined by gas chroma- Paper 5, Revision 2’’ (1991), pp. 203 and tography as described in the ‘‘Guide to 204, which is incorporated by reference, Specifications for General Notices, in accordance with 5 U.S.C. 552(a) and 1 General Analytical Techniques, Identi- CFR part 51. Copies are available from fication Tests, Test Solutions, and the Office of Premarket Approval, Cen- Other Reference Materials,’’ in the ter for Food Safety and Applied Nutri- ‘‘Compendium of Food Additive Speci- tion (HFS–200), Food and Drug Admin- fications, Addendum 4, FAO Food and istration, 5100 Paint Branch Pkwy., Nutrition Paper 5, Revision 2,’’ (1991), College Park, MD 20740, or may be ex- pp. 13–26, which is incorporated by ref- amined at the Center for Food Safety erence; see paragraph (b)(2) of this sec- and Applied Nutrition’s Library, 5100 tion for availability of the incorpora- Paint Branch Pkwy., College Park, MD tion by reference. 20740, or at the National Archives and (c) The food additive is used as a sta- Records Administration (NARA). For bilizer (as defined in § 170.3(o)(28) of this information on the availability of this chapter) of emulsions of flavoring oils material at NARA, call 202–741–6030, or in nonalcoholic beverages. go to: http://www.archives.gov/ (d) The total SAIB content of a bev- federallregister/ erage containing the additive does not

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exceed 300 milligrams/kilogram of the (d) When the name ‘‘polyglycerate finished beverage. 60’’ is used in labeling it shall be followed by either ‘‘polyoxyethylene (20) [64 FR 29958, June 4, 1999; 64 FR 43072, Aug. 9, 1999] mono-and diglycerides of fatty acids’’ or ‘‘ethoxylated mono- and § 172.834 Ethoxylated mono- and diglycerides’’ in parentheses. diglycerides. [42 FR 14491, Mar. 15, 1977, as amended at 42 The food additive ethoxylated mono- FR 37973, July 26, 1977; 50 FR 49536, Dec. 3, and diglycerides (polyoxyethylene (20) 1985] mono- and diglycerides of fatty acids) § 172.836 Polysorbate 60. (polyglycerate 60) may be safely used in food in accordance with the fol- The food additive polysorbate 60 lowing prescribed conditions: (polyoxyethylene (20) sorbitan mono- (a) The food additive is manufactured stearate) which is a mixture of by: polyoxyethylene ethers of mixed par- (1) Glycerolysis of edible fats pri- tial stearic and palmitic acid esters of marily composed of stearic, palmitic, sorbitol anhydrides and related com- and myristic acids; or pounds, may be safely used in food in (2) Direct esterification of glycerol accordance with the following pre- with a mixture of primarily stearic, scribed conditions: palmitic, and myristic acids; (a) The food additive is manufactured by reacting stearic acid (usually con- to yield a product with less than 0.3 taining associated fatty acids, chiefly acid number and less than 0.2 percent palmitic) with sorbitol to yield a prod- water, which is then reacted with uct with a maximum acid number of 10 ethylene oxide. and a maximum water content of 0.2 (b) The additive meets the following percent, which is then reacted with specifications: ethylene oxide. (b) The food additive meets the fol- Saponification number, 65–75. lowing specifications: Acid number, 0–2. Hydroxyl number, 65–80. Saponification number 45–55. Oxyethylene content, 60.5–65.0 percent. Acid number 0–2. Hydroxyl number 81–96. (c) The additive is used or intended Oxyethylene content 65 percent–69.5 percent. for use in the following foods when standards of identity established under (c) It is used or intended for use as section 401 of the Act do not preclude follows: such use: (1) As an emulsifier in whipped edible oil topping with or without one or a Use Limitations combination of the following: (i) Sorbitan monostearate; 1. As an emulsifier in pan-re- Not to exceed levels required (ii) Polysorbate 65; lease agents for and as a to produce the intended ef- dough conditioner in yeast- fects, total not to exceed (iii) Polysorbate 80; leavened bakery products. 0.5 percent by weight of the flour used. whereby the maximum amount of the 2. As an emulsifier in cakes Not to exceed 0.5 percent by additive or additives used does not ex- and cake mixes. weight of the dry ingredi- ceed 0.4 percent of the weight of the ents. finished whipped edible oil topping; ex- 3. As an emulsifier in Not to exceed 0.45 percent whipped vegetable oil top- by weight of the finished cept that a combination of the additive pings and topping mixes. whipped vegetable oil top- with sorbitan monostearate may be pings. used in excess of 0.4 percent, provided 4. As an emulsifier in icings Not to exceed 0.5 percent by that the amount of the additive does and icing mixes. weight of the finished 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. finished whipped edible oil topping. 6. As an emulsifier in edible Not to exceed 0.4 percent by 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 bination of the following: cream in beverage coffee. (i) Polysorbate 65.

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(ii) Sorbitan monostearate. (7) As an emulsifier in nonstandardized dressings whereby the maximum When used alone, the maximum amount of the additive does not exceed amount of polysorbate 60 shall not ex- 0.3 percent of the weight of the finished ceed 0.46 percent of the cake or cake dressings. mix, on a dry-weight basis. When used (8) As an emulsifier, alone or in com- with polysorbate 65 and/or sorbitan bination with polysorbate 80, in monostearate, it shall not exceed 0.46 shortenings and edible oils intended for percent, nor shall the polysorbate 65 use in foods as follows, when standards exceed 0.32 percent or the sorbitan of identity established under section monostearate exceed 0.61 percent, and 401 of the act do not preclude such use: no combination of these emulsifiers (i) It is used alone in an amount not shall exceed 0.66 percent of the cake or to exceed 1 percent of the weight of the cake mix, all calculated on a dry- finished shortening or oil. weight basis. (ii) It is used with polysorbate 80 in (3) As an emulsifier, alone or in com- any combination providing no more bination with sorbitan monostearate, than 1 percent of polysorbate 60 and no in nonstandardized confectionery coat- more than 1 percent of polysorbate 80, ings and standardized cacao products provided that the total combination specified in §§ 163.123, 163.130, 163.135, does not exceed 1 percent of the fin- 163.140, 163.145, and 163.150 of this chap- ished shortening or oil. ter, as follows: (iii) The 1–percent limitation speci- (i) It is used alone in an amount not fied in paragraph (c)(8) (i) and (ii) of to exceed 0.5 percent of the weight of this section may be exceeded in premix the finished nonstandardized confec- concentrates of shortening or edible oil tionery coating or standardized cacao if the labeling complies with the re- product. quirements of paragraph (d) of this sec- (ii) It is used with sorbitan mono- tion. stearate in any combination of up to (9) As an emulsifier in solid-state, ed- 0.5 percent of polysorbate 60 and up to ible vegetable fat-water emulsions in- 1 percent of sorbitan monostearate: tended for use as substitutes for milk Provided, That the total combination or cream in beverage coffee, with or does not exceed 1 percent of the weight without one or a combination of the of the finished nonstandardized confec- following: tionery coating or standardized cacao (i) Polysorbate 65. product. (ii) Sorbitan monostearate. (4) [Reserved] The maximum amount of the additive (5) As an emulsifier in cake icings or additives shall not exceed 0.4 per- and cake fillings, with or without one cent by weight of the finished edible or a combination of the following: vegetable fat-water emulsion. (i) Polysorbate 65. (10) As a foaming agent in non- (ii) Sorbitan monostearate. alcoholic mixes, to be added to alco- When used alone, the maximum holic beverages in the preparation of amount of polysorbate 60 shall not ex- mixed alcoholic drinks, at a level not ceed 0.46 percent of the weight of the to exceed 4.5 percent by weight of the cake icings and cake fillings. When nonalcoholic mix. used with polysorbate 65 and/or sorbi- (11) As a dough conditioner in yeast- tan monostearate, it shall not exceed leavened bakery products in an amount 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.

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(13) As a dispersing agent in artifi- tristearate), which is a mixture of cially sweetened gelatin desserts and in polyoxyethylene ethers of mixed ste- artificially sweetened gelatin dessert aric acid esters of sorbitol anhydrides mixes, whereby the amount of the addi- and related compounds, may be safely tive does not exceed 0.5 percent on a used in food in accordance with the fol- dry-weight basis. lowing prescribed conditions: (14) As an emulsifier in chocolate fla- (a) The food additive is manufactured vored syrups, whereby the maximum by reacting stearic acid (usually con- amount of the additive does not exceed taining associated fatty acids, chiefly 0.05 percent in the finished product. palmitic) with sorbitol to yield a prod- (15) As a surfactant and wetting uct with a maximum acid number of 15 agent for natural and artificial colors and a maximum water content of 0.2 in food as follows: percent, which is then reacted with (i) In powdered soft drink mixes in an ethylene oxide. amount not to exceed 4.5 percent by (b) The food additive meets the fol- weight of the mix. lowing specifications: (ii) In sugar-based gelatin dessert Saponification number 88–98. mixes in an amount not to exceed 0.5 Acid number 0–2. percent by weight of the mix. Hydroxyl number 44–60. (iii) In artificially sweetened gelatin Oxyethylene content 46 percent–50 percent. dessert mixes in an amount not to ex- (c) The additive is used, or intended ceed 3.6 percent by weight of the mix. for use, as follows: (iv) In sugar-based pudding mixes in (1) As an emulsifier in ice cream, fro- an amount not to exceed 0.5 percent by zen custard, ice milk, fruit sherbet and weight of the mix. nonstandardized frozen desserts when (v) In artificially sweetened pudding used alone or in combination with mixes in an amount not to exceed 0.5 polysorbate 80, whereby the maximum percent by weight of the mix. amount of the additives, alone or in (16) As an emulsifier in ice cream, combination, does not exceed 0.1 per- frozen custard, fruit sherbet, and non- cent of the finished frozen dessert. standardized frozen desserts when used (2) As an emulsifier in cakes and cake alone or in combination with poly- mixes, with or without one or a com- sorbate 65 and/or polysorbate 80, where- bination of the following: by the maximum amount of the addi- (i) Sorbitan monostearate. tives, alone or in combination, does not (ii) Polysorbate 60. exceed 0.1 percent of the finished frozen dessert. When used alone, the maximum (d) To assure safe use of the additive, amount of polysorbate 65 shall not ex- in addition to the other information re- ceed 0.32 percent of the cake or cake quired by the Act: mix, on a dry-weight basis. When used (1) The label of the additive and any with sorbitan monostearate and/or intermediate premixes shall bear: polysorbate 60, it shall not exceed 0.32 (i) The name of the additive. percent, nor shall the sorbitan mono- (ii) A statement of the concentration stearate exceed 0.61 percent or the or strength of the additive in any in- polysorbate 60 exceed 0.46 percent, and termediate premixes. no combination of these emulsifiers (2) The label or labeling shall bear shall exceed 0.66 percent of the cake or adequate directions to provide a final cake mix, all calculated on a dry- product that complies with the limita- weight basis. tions prescribed in paragraph (c) of this (3) As an emulsifier in whipped edible section. oil topping with or without one or a combination of the following: [42 FR 14491, Mar. 15, 1977, as amended at 43 (i) Sorbitan monostearate; FR 2871, Jan. 25, 1978; 45 FR 58836, Sept. 5, (ii) Polysorbate 60; 1980; 46 FR 8466, Jan. 27, 1981; 64 FR 57976, Oct. 28, 1999] (iii) Polysorbate 80; whereby the maximum amount of the § 172.838 Polysorbate 65. additive or additives used does not ex- The food additive polysorbate 65 ceed 0.4 percent of the weight of the (polyoxyethylene (20) sorbitan finished whipped edible oil topping.

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(4) As an emulsifier in solid-state, ed- sorbitol to yield a product with a max- ible vegetable fat-water emulsions in- imum acid number of 7.5 and a max- tended for use as substitutes for milk imum water content of 0.5 percent, or cream in beverage coffee, with or which is then reacted with ethylene without one or a combination of the oxide. following: (b) The food additive meets the fol- (i) Sorbitan monostearate. lowing specifications: (ii) Polysorbate 60. Saponification number 45–55. The maximum amount of the additive Acid number 0–2. or additives shall not exceed 0.4 per- Hydroxyl number 65–80. cent by weight of the finished edible Oxyethylene content 65 percent–69.5 percent. vegetable fat-water emulsion. (c) The additive is used or intended (5) As an emulsifier in cake icings for use as follows: and cake fillings, with or without one (1) An emulsifier in ice cream, frozen or a combination of the following: custard, ice milk, fruit sherbet, and (i) Sorbitan monostearate. nonstandardized frozen desserts, when (ii) Polysorbate 60. used alone or in combination with polysorbate 65 whereby the maximum When used alone, the maximum amount of the additives, alone or in amount of polysorbate 65 shall not ex- combination, does not exceed 0.1 per- ceed 0.32 percent of the weight of the cent of the finished frozen dessert. cake icing or cake filling. When used (2) In yeast-defoamer formulations with sorbitan monostearate and/or whereby the maximum amount of the polysorbate 60, it shall not exceed 0.32 additive does not exceed 4 percent of percent, nor shall the sorbitan mono- the finished yeast defoamer and the stearate exceed 0.7 percent or the poly- maximum amount of the additive in sorbate 60 exceed 0.46 percent, and no the yeast from such use does not ex- combination of these emulsifiers shall ceed 4 parts per million. exceed 1 percent of the weight of the (3) As a solubilizing and dispersing cake icing or cake filling. agent in pickles and pickle products, (d) To assure safe use of the additive, whereby the maximum amount of the in addition to the other information re- additive does not exceed 500 parts per quired by the Act: million. (1) The label of the additive and any (4) As a solubilizing and dispersing intermediate premixes shall bear: agent in: (i) The name of the additive. (i) Vitamin-mineral preparations (ii) A statement of the concentration containing calcium caseinate in the ab- or strength of the additive in any in- sence of fat-soluble vitamins, whereby termediate premixes. the maximum intake of polysorbate 80 (2) The label or labeling shall bear shall not exceed 175 milligrams from adequate directions to provide a final the recommended daily dose of the product that complies with the limita- preparations. tions prescribed in paragraph (c) of this (ii) Fat-soluble vitamins in vitamin section. and vitamin-mineral preparations con- [42 FR 14491, Mar. 15, 1977, as amended at 43 taining no calcium caseinate, whereby FR 2871, Jan. 20, 1978] the maximum intake of polysorbate 80 shall not exceed 300 milligrams from § 172.840 Polysorbate 80. the recommended daily dose of the The food additive polysorbate 80 preparations. (polyoxyethylene (20) sorbitan (iii) In vitamin-mineral preparations monooleate), which is a mixture of containing both calcium caseinate and polyoxyethylene ethers of mixed par- fat-soluble vitamins, whereby the max- tial oleic acid esters of sorbitol anhy- imum intake of polysorbate 80 shall drides and related compounds, may be not exceed 475 milligrams from the rec- safely used in food in accordance with ommended daily dose of the prepara- the following prescribed conditions: tions. (a) The food additive is manufactured (5) As a surfactant in the production by reacting oleic acid (usually con- of coarse crystal sodium chloride taining associated fatty acids) with whereby the maximum amount of the

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additive in the finished sodium chlo- prior to application of such dilutions to ride does not exceed 10 parts per mil- the growing crop. Residues resulting lion. from such use are exempt from the re- (6) In special dietary foods, as an quirement of a tolerance. When so used emulsifier for edible fats and oils, with or intended for use, the additive shall directions for use which provide for the be exempt from the requirements of ingestion of not more than 360 milli- paragraph (d)(1) of this section. grams of polysorbate 80 per day. (13) As a defoaming agent in the prep- (7) As a solubilizing and dispersing aration of the creaming mixture for agent for dill oil in canned spiced green cottage cheese and lowfat cottage beans, not to exceed 30 parts per mil- cheese, as identified in §§ 133.128 and lion. 133.131 of this chapter, respectively, (8) As an emulsifier, alone or in com- whereby the amount of the additive bination with polysorbate 60, in does not exceed .008 percent by weight shortenings and edible oils intended for of the finished products. use in foods as follows, when standards (14) As a surfactant and wetting of identity established under section agent for natural and artificial colors 401 of the act do not preclude such use: for use in barbecue sauce where the (i) It is used alone in an amount not level of the additive does not exceed to exceed 1 percent of the weight of the 0.005 percent by weight of the barbecue finished shortening or oil. sauce. (ii) It is used with polysorbate 60 in (d) To assure safe use of the additive, any combination providing no more in addition to the other information re- than 1 percent of polysorbate 80 and no quired by the Act: more than 1 percent of polysorbate 60, (1) The label of the additive and any provided that the total combination intermediate premixes shall bear: does not exceed 1 percent of the fin- (i) The name of the additive. ished shortening or oil. (ii) A statement of the concentration (iii) The 1–percent limitation speci- or strength of the additive in any in- fied in paragraph (c)(8) (i) and (ii) of termediate premixes. this section may be exceeded in premix (2) The label or labeling shall bear concentrates of shortening or edible oil adequate directions to provide a final if the labeling complies with the re- product that complies with the limita- quirements of paragraph (d) of this sections prescribed in paragraph (c) of this tion. section. (9) As an emulsifier in whipped edible [42 FR 14491, Mar. 15, 1977, as amended at 43 oil topping with or without one or a FR 2871, Jan. 20, 1978; 45 FR 58835, Sept. 5, combination of the following: 1980; 46 FR 8466, Jan. 27, 1981] (i) Sorbitan monostearate; (ii) Polysorbate 60; § 172.841 Polydextrose. (iii) Polysorbate 65; Polydextrose as identified in this sec- whereby the maximum amount of the tion may be safely used in food in ac- additive or additives used does not ex- cordance with the following prescribed ceed 0.4 percent of the weight of the conditions: finished whipped edible oil topping. (a)(1) Polydextrose (CAS Reg. No. (10) It is used as a wetting agent in 68424–04–4) is a partially metabolizable scald water for poultry defeathering, water-soluble polymer prepared by the followed by potable water rinse. The condensation of a melt which consists concentration of the additive in the either of approximately 89 percent D- scald water does not exceed 0.0175 per- glucose, 10 percent sorbitol, and 1 percent. cent citric acid or of approximately 90 (11) As a dispersing agent in gelatin percent D-glucose, 10 percent sorbitol, desserts and in gelatin dessert mixes, and 0.1 percent phosphoric acid, on a whereby the amount of the additive weight basis. does not exceed 0.082 percent on a dry- (2) Polydextrose may be partially weight basis. neutralized with potassium hydroxide, (12) As an adjuvant added to herbi- or partially reduced by transition cide use and plant-growth regulator metal catalytic hydrogenation in aque- use dilutions by a grower or applicator ous solution.

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(b) The additive meets the specifica- food in accordance with the following tions of the ‘‘Food Chemicals Codex,’’ prescribed conditions: 5th ed. (January 1, 2004), pp. 336–339, (a) The food additive is manufactured and the First Supplement to the 5th by reacting stearic acid (usually con- Edition of the Food Chemicals Codex taining associated fatty acids, chiefly (March 1, 2006), p. 37, which are incor- palmitic) with sorbitol to yield essen- porated by reference. The Director of tially a mixture of esters. the Office of the Federal Register ap- (b) The food additive meets the fol- proves this incorporation by reference lowing specifications: in accordance with 5 U.S.C. 552(a) and 1 Saponification number, 147–157 CFR part 51. You may obtain a copy Acid number, 5–10 from The National Academies Press, Hydroxyl number, 235–260 500 Fifth St. NW., Washington, DC 20001 (c) It is used or intended for use, (Internet address http://www.nap.edu). alone or in combination with poly- You may inspect a copy at the Center sorbate 60 as follows: for Food Safety and Applied Nutri- (1) As an emulsifier in whipped edible tion’s Library, Food and Drug Admin- oil topping with or without one or a istration, 5100 Paint Branch Pkwy., combination of the following: College Park, MD 20740, or at the Na- (i) Polysorbate 60; tional Archives and Records Adminis- (ii) Polysorbate 65; tration (NARA). For information on (iii) Polysorbate 80; the availability of this material at whereby the maximum amount of the NARA, call 202–741–6030, or go to: http:// additive or additives used does not ex- www.archives.gov/federal-register/cfr/ibr- ceed 0.4 percent of the weight of the locations.html. finished whipped edible oil topping; ex- (c) When standards of identity estab- cept that a combination of the additive lished under section 401 of the act do with polysorbate 60 may be used in ex- not preclude such use, polydextrose cess of 0.4 percent: Provided, That the may be used in accordance with cur- amount of the additive does not exceed rent good manufacturing practices as a 0.27 percent and the amount of poly- bulking agent, formulation aid, humec- sorbate 60 does not exceed 0.77 percent tant, and texturizer in all foods, except of the weight of the finished whipped meat and poultry, baby food, and in- edible oil topping. fant formula. (2) As an emulsifier in cakes and cake (d) If the food containing the additive mixes, with or without one or a com- purports to be or is represented for spe- bination of the following: cial dietary uses, it shall be labeled in (i) Polysorbate 65. compliance with part 105 of this chap- (ii) Polysorbate 60. ter. When used alone, the maximum (e) The label and labeling of food a amount of sorbitan monostearate shall single serving of which would be ex- not exceed 0.61 percent of the cake or pected to exceed 15 grams of the addi- cake mix, on a dry-weight basis. When tive shall bear the statement: ‘‘Sen- used with polysorbate 65 and/or poly- sitive individuals may experience a sorbate 60, it shall not exceed 0.61 per- laxative effect from excessive con- cent, nor shall the polysorbate 65 ex- sumption of this product’’. ceed 0.32 percent or the polysorbate 60 [46 FR 30081, June 5, 1981, as amended at 59 exceed 0.46 percent, and no combina- FR 37421, July 22, 1994; 60 FR 54425, Oct. 24, tion of the emulsifiers shall exceed 0.66 1995; 61 FR 14480, Apr. 2, 1996; 62 FR 30985, percent of the weight of the cake or June 6, 1997; 63 FR 57597, Oct. 28, 1998; 65 FR cake mix, calculated on a dry-weight 64605, Oct. 30, 2000; 65 FR 79719, Dec. 20, 2000; basis. 72 FR 46564, Aug. 21, 2007] (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:

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(i) It is used alone in an amount not (1) The label of the additive and any to exceed 1 percent of the weight of the intermediate premixes shall bear: finished nonstandardized confectionery (i) The name of the additive. coating or standardized cacao product. (ii) A statement of the concentration (ii) It is used with polysorbate 60 in or strength of the additive in any in- any combination of up to 1 percent sor- termediate premixes. bitan monostearate and up to 0.5 per- (2) The label or labeling shall bear cent polysorbate 60 provided that the adequate directions to provide a final total combination does not exceed 1 product that complies with the limita- percent of the weight of the finished tions prescribed in paragraph (c) of this nonstandardized confectionery coating section. or standardized cacao product. [42 FR 14491, Mar. 15, 1977, as amended at 43 (4) As an emulsifier in cake icings FR 2871, Jan. 20, 1978] and cake fillings, with or without one or a combination of the following: § 172.844 Calcium stearoyl-2-lactylate. (i) Polysorbate 65. The food additive calcium stearoyl-2- (ii) Polysorbate 60. lactylate may be safely used in or on food in accordance with the following When used alone, the maximum prescribed conditions: amount of sorbitan monostearate shall (a) The additive, which is a mixture not exceed 0.7 percent of the weight of of calcium salts of stearoyl lactylic the cake icing or cake filling. When acids and minor proportions of other used with polysorbate 65 and/or poly- calcium salts of related acids, is manu- sorbate 60, it shall not exceed 0.7 per- factured by the reaction of stearic acid cent, nor shall the polysorbate 65 ex- and lactic acid and conversion to the ceed 0.32 percent or the polysorbate 60 calcium salts. exceed 0.46 percent, and no combina- (b) The additive meets the following tion of these emulsifiers shall exceed 1 specifications: percent of the weight of the cake icing or cake filling. Acid number, 50–86. (5) As an emulsifier in solid-state, ed- Calcium content, 4.2–5.2 percent. ible vegetable fat-water emulsions in- Lactic acid content, 32–38 percent. tended for use as substitutes for milk Ester number, 125–164. or cream in beverage coffee, with or (c) It is used or intended for use as without one or a combination of the follows: following: (1) As a dough conditioner in yeast- (i) Polysorbate 60. leavened bakery products and prepared (ii) Polysorbate 65. mixes for yeast-leavened bakery products in an amount not to exceed 0.5 The maximum amount of the additive part for each 100 parts by weight of or additives shall not exceed 0.4 per- flour used. cent by weight of the finished edible (2) As a whipping agent in: vegetable fat-water emulsion. (i) Liquid and frozen egg white at a (6) It is used alone as a rehydration level not to exceed 0.05 percent. aid in the production of active dry (ii) Dried egg white at a level not to yeast in an amount not to exceed 1 per- exceed 0.5 percent. cent by weight of the dry yeast. (iii) Whipped vegetable oil topping at (7) As an emulsifier, alone or in com- a level not to exceed 0.3 percent of the bination with polysorbate 60, in the weight of the finished whipped vege- minimum quantity required to accom- table oil topping. plish the intended effect, in formula- (3) As a conditioning agent in dehy- tions of white mineral oil conforming drated potatoes in an amount not to with § 172.878 and/or petroleum wax exceed 0.5 percent by weight thereof. conforming with § 172.886 for use as pro- (d) To assure safe use of the additive: tective coatings on raw fruits and vege- (1) The label and labeling of the food tables. additive and any intermediate premix (d) To assure safe use of the additive, prepared therefrom shall bear, in addi- in addition to the other information re- tion to the other information required quired by the Act: by the act, the following:

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(i) The name of the additive. (4) As a formulation aid, processing (ii) A statement of the concentration aid, or surface-active agent in dehy- or strength of the additive in any in- drated potatoes, in an amount not to termediate premixes. exceed 0.5 percent of the dry weight of (2) The label or labeling of the food the food. additive shall also bear adequate direc- (5) As an emulsifier, stabilizer, or tions of use to provide a finished food texturizer in snack dips, at a level not that complies with the limitations pre- to exceed 0.2 percent by weight of the scribed in paragraph (c) of this section. finished product. (6) As an emulsifier, stabilizer, or § 172.846 Sodium stearoyl lactylate. texturizer in cheese substitutes and The food additive sodium stearoyl imitations and cheese product sub- lactylate (CAS Reg. No. 25–383–997) may stitutes and imitations, at a level not be safely used in food in accordance to exceed 0.2 percent by weight of the with the following prescribed condi- finished food. tions: (7) As an emulsifier, stabilizer, or (a) The additive, which is a mixture texturizer in sauces or gravies, and the of sodium salts of stearoyl lactylic products containing the same, in an acids and minor proportions of sodium amount not to exceed 0.25 percent by salts of related acids, is manufactured weight of the finished food. by the reaction of stearic acid and lac- (8) In prepared mixes for each of the tic acid and conversion to the sodium foods listed in paragraphs (c) (1) salts. through (7) of this section, provided the (b) The additive meets the specifica- additive is used only as specified in tions of the ‘‘Food Chemicals Codex,’’ each of those paragraphs. 3d Ed. (1981), pp. 300–301, which is incor- (9) As an emulsifier, stabilizer, or porated by reference. Copies may be texturizer in cream liqueur drinks, at a obtained from the National Academy level not to exceed 0.5 percent by Press, 2101 Constitution Ave. NW., weight of the finished product. Washington, DC 20418, or may be exam- [45 FR 51767, Aug. 5, 1980, as amended at 49 ined at the National Archives and FR 10105, Mar. 19, 1984; 50 FR 49536, Dec. 3, Records Administration (NARA). For 1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333, Jan. information on the availability of this 27, 1986; 65 FR 60859, Oct. 13, 2000] material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ § 172.848 Lactylic esters of fatty acids. federallregister/ Lactylic esters of fatty acids may be codeloflfederallregulations/ safely used in food in accordance with ibrllocations.html. the following prescribed conditions: (c) It is used or intended for use as (a) They are prepared from lactic follows when standards of identity es- acid and fatty acids meeting the re- tablished under section 401 of the Act quirements of § 172.860(b) and/or oleic do not preclude such use: acid derived from tall oil fatty acids (1) As a dough strengthener, emulsi- meeting the requirements of § 172.862. fier, or processing aid in baked prod- (b) They are used as emulsifiers, plas- ucts, pancakes, and waffles, in an ticizers, or surface-active agents in the amount not to exceed 0.5 part for each following foods, when standards of 100 parts by weight of flour used. identity do not preclude their use: (2) As a surface-active agent, emulsi- Foods Limitations fier, or stabilizer in icings, fillings, puddings, and toppings, at a level not Bakery mixes ...... to exceed 0.2 percent by weight of the Baked products ...... Cake icings, fillings, and toppings finished food. Dehydrated fruits and vegetables (3) As an emulsifier or stabilizer in Dehydrated fruit and vegetable liquid and solid edible fat-water emul- juices. Edible vegetable fat-water emul- As substitutes for milk or sions intended for use as substitutes sions. cream in beverage cof- for milk or cream in beverage coffee, at fee. a level not to exceed 0.3 percent by Frozen desserts ...... Liquid shortening ...... For household use. weight of the finished edible fat-water Pancake mixes ...... emulsion. Precooked instant rice ......

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Foods Limitations (a) They are prepared from corn oil, cottonseed oil, lard, palm oil from Pudding mixes ...... fruit, peanut oil, safflower oil, sesame oil, soybean oil, and tallow and the (c) They are used in an amount not fatty acids derived from these sub- greater than required to produce the stances (hydrogenated and nonhydro- intended physical or technical effect, genated) meeting the requirements of and they may be used with shortening § 172.860(b) and/or oleic acid derived and edible fats and oils when such are from tall oil fatty acids meeting the required in the foods identified in para- requirements of § 172.862. graph (b) of this section. (b) They are used as emulsifiers in § 172.850 Lactylated fatty acid esters food, in amounts not greater than that of glycerol and propylene glycol. required to produce the intended physical or technical effect. The food additive lactylated fatty (c) Polyglycerol esters of a mixture acid esters of glycerol and propylene of stearic, oleic, and coconut fatty glycol may be safely used in food in ac- acids are used as a cloud inhibitor in cordance with the following prescribed vegetable and salad oils when use is conditions: not precluded by standards of identity. (a) The additive is a mixture of esters The fatty acids used in the production produced by the lactylation of a prod- of the polyglycerol esters meet the re- uct obtained by reacting edible fats or quirements of § 172.860(b), and the oils with propylene glycol. polyglycerol esters are used at a level (b) The additive meets the following not in excess of the amount required to specifications: Water insoluble com- perform its cloud-inhibiting effect. bined lactic acid, 14–18 percent; and Oleic acid derived from tall oil fatty acid number, 12 maximum. acids conforming with § 172.862 may be (c) It is used in amounts not in excess used as a substitute for or together of that reasonably required to produce with the oleic acid permitted by this the intended physical effect as an paragraph. emulsifier, plasticizer, or surface-ac- (d) Polyglycerol esters of butter oil tive agent in food. fatty acids are used as emulsifiers in combination with other approved emul- § 172.852 Glyceryl-lacto esters of fatty sifiers in dry, whipped topping base. acids. The fatty acids used in the production Glyceryl-lacto esters of fatty acids of the polyglycerol esters meet the re- (the lactic acid esters of mono- and quirements of § 172.860(b), and the diglycerides) may be safely used in polyglycerol esters are used at a level food in accordance with the following not in excess of the amount required to prescribed conditions: perform their emulsifying effect. (a) They are manufactured from glycerin, lactic acid, and fatty acids con- § 172.856 Propylene glycol mono- and forming with § 172.860 and/or oleic acid diesters of fats and fatty acids. derived from tall oil fatty acids con- Propylene glycol mono- and diesters forming with § 172.862 and/or edible fats of fats and fatty acids may be safely and oils. used in food, subject to the following (b) They are used in amounts not in prescribed conditions: excess of those reasonably required to (a) They are produced from edible accomplish their intended physical or fats and/or fatty acids in compliance technical effect as emulsifiers and plas- with § 172.860 and/or oleic acid derived ticizers in food. from tall oil fatty acids in compliance with § 172.862. § 172.854 Polyglycerol esters of fatty (b) They are used in food in amounts acids. not in excess of that reasonably re- Polyglycerol esters of fatty acids, up quired to produce their intended effect. to and including the decaglycerol esters, may be safely used in food in ac- § 172.858 Propylene glycol alginate. cordance with the following prescribed The food additive propylene glycol conditions: alginate (CAS Reg. No. 9005–37–2) may

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be used as an emulsifier, flavoring ad- at a level not to exceed 0.6 percent by juvant, formulation aid, stabilizer, sur- weight of the finished product. factant, or thickener in foods in ac- (9) As a flavoring adjunct or adjuvant cordance with the following prescribed in seasonings and flavors at a level not conditions: to exceed 1.7 percent by weight of the (a) The additive meets the specifica- finished product. tions of the Food Chemicals Codex, 3d (10) As an emulsifier, flavoring adju- Ed. (1981), p. 256, which is incorporated vant, formulation aid, stabilizer or by reference (Copies are available from thickener, or surface active agent in the National Academy Press, 2101 Con- other foods, where applicable, at a stitution Ave. NW., Washington, DC level not to exceed 0.3 percent by 20418, or available for inspection at the weight of the finished product. National Archives and Records Admin- (c) To ensure safe use of the additive, istration (NARA). For information on the label of the food additive container the availability of this material at shall bear, in addition to the other in- NARA, call 202–741–6030, or go to: http:// formation required by the act: www.archives.gov/federallregister/ (1) The name of the additive, ‘‘pro- codeloflfederallregulations/ pylene glycol alginate’’ or ‘‘propylene ibrllocations.html.), and the additional glycol ester of alginic acid’’. specification that it shall have up to 85 (2) Adequate directions for use. percent of the carboxylic acid groups [47 FR 29950, July 9, 1982] esterified with the remaining groups either free or neutralized. § 172.859 Sucrose fatty acid esters. (b) The additive is used or intended Sucrose fatty acid esters identified in for use in the following foods as defined this section may be safely used in ac- in § 170.3(n) of this chapter, when stand- cordance with the following prescribed ards of identity established under sec- conditions: tion 401 of the act do not preclude such (a) Sucrose fatty acid esters are the use: mono-, di-, and tri-esters of sucrose (1) As a stabilizer in frozen dairy des- with fatty acids and are derived from serts, in fruit and water ices, and in sucrose and edible tallow or hydro- confections and frostings at a level not genated edible tallow or edible vege- to exceed 0.5 percent by weight of the table oils. The only solvents which finished product. may be used in the preparation of su- (2) As an emulsifier, flavoring adju- crose fatty acid esters are those gen- vant, stabilizer, or thickener in baked erally recognized as safe in food or reg- goods at a level not to exceed 0.5 per- ulated for such use by an appropriate cent by weight of the finished product. section in this part. Ethyl acetate or (3) As an emulsifier, stabilizer, or methyl ethyl ketone or dimethyl sulf- thickener in cheeses at a level not to oxide and isobutyl alcohol (2-methyl-1- 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, 5100 Paint Branch Pkwy., finished product. College Park, MD 20740, or available for (7) As a stabilizer in jams and jellies inspection at the National Archives at a level not to exceed 0.4 percent by and Records Administration (NARA). weight of the finished product. For information on the availability of (8) As an emulsifier, stabilizer, or this material at NARA, call 202–741– thickener in condiments and relishes 6030, or go to: http://www.archives.gov/

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federallregister/ tled ‘‘Determination of Dimethyl Sulf- codeloflfederallregulations/ oxide,’’ which is incorporated by ref- ibrllocations.html. erence. Copies are available from the (2) The free sucrose content is not Center for Food Safety and Applied Nu- more than 5 percent as determined by trition (HFS–200), Food and Drug Ad- Test S.2 in the method titled ‘‘Sucrose ministration, 5100 Paint Branch Pkwy., Fatty Acid Esters, Method of Assay,’’ College Park, MD 20740, or available for which is incorporated by reference. The inspection at the National Archives availability of this incorporation by and Records Administration (NARA). reference is given in paragraph (b)(1) of For information on the availability of this section. this material at NARA, call 202–741– (3) The acid value is not more than 6. 6030, or go to: http://www.archives.gov/ (4) The residue on ignition (sulfated federallregister/ ash) is not more than 2 percent. codeloflfederallregulations/ (5) The total ethyl acetate content is ibrllocations.html. not more than 350 parts per million as (11) The total isobuytl alcohol (2- determined by a method titled ‘‘Deter- methyl-1-propanol) content is not more mination of Ethyl Acetate,’’ which is than 10 parts per million as determined incorporated by reference. Copies are by a method entitled ‘‘Determination available from the Center for Food of Isobutyl Alcohol,’’ which is incor- Safety and Applied Nutrition (HFS– porated by reference. Copies are avail- 200), Food and Drug Administration, able from the Center for Food Safety 5100 Paint Branch Pkwy., College Park, and Applied Nutrition (HFS–200), Food MD 20740, or available for inspection at and Drug Administration, 5100 Paint the National Archives and Records Ad- Branch Pkwy., College Park, MD 20740, ministration (NARA). For information or available for inspection at the Na- on the availability of this material at tional Archives and Records Adminis- NARA, call 202–741–6030, or go to: http:// tration (NARA). For information on www.archives.gov/federallregister/ the availability of this material at codeloflfederallregulations/ NARA, call 202–741–6030, or go to: http:// ibrllocations.html. www.archives.gov/federallregister/ (6) Arsenic is not more than 3 parts codeloflfederallregulations/ per million. ibrllocations.html. (7) Total heavy metal content (as Pb) (c) Sucrose fatty acid esters may be is not more than 50 parts per million. used as follows when standards of iden- (8) Lead is not more than 10 parts per tity established under section 401 of million. the Federal Food, Drug, and Cosmetic (9) The total content of methyl ethyl Act do not preclude such use: ketone or of methanol shall not be (1) As emulsifiers as defined in more than 10 parts per million as deter- § 170.3(o)(8) of this chapter, or as stabi- mined by a method titled ‘‘Methyl lizers as defined in § 170.3(o)(28) of this Ethyl Ketone Test; Methyl Alcohol chapter, in baked goods and baking Test,’’ which is incorporated by ref- mixes as defined in § 170.3(n)(1) of this erence. Copies are available from the chapter, in chewing gum as defined in Center for Food Safety and Applied Nu- § 170.3(n)(6) of this chapter, in coffee trition (HFS–200), Food and Drug Ad- and tea beverages with added dairy in- ministration, 5100 Paint Branch Pkwy., gredients and/or dairy product ana- College Park, MD 20740, or available for logues, in confections and frostings as inspection at the National Archives defined in § 170.3(n)(9) of this chapter, and Records Administration (NARA). in dairy product analogues as defined For information on the availability of in § 170.3(n)(10) of this chapter, in frozen this material at NARA, call 202–741– dairy desserts and mixes as defined in 6030, or go to: http://www.archives.gov/ § 170.3(n)(20) of this chapter, and in federallregister/ whipped milk products. codeloflfederallregulations/ (2) As texturizers as defined in ibrllocations.html. § 170.3(o)(32) of this chapter in biscuit (10) The total dimethyl sulfoxide con- 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

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§ 170.3(n)(9) of this chapter, and in the 13th Ed. (1980) of the ‘‘Official surimi-based fabricated seafood prod- Methods of Analysis of the Association ucts. of Official Analytical Chemists,’’ which (3) As components of protective coat- is incorporated by reference. Copies are ings applied to fresh apples, avocados, available from the AOAC INTER- bananas, banana plantains, limes, mel- NATIONAL, 481 North Frederick Ave., ons (honeydew and cantaloupe), pa- suite 500, Gaithersburg, MD 20877, or paya, peaches, pears, pineapples, and available for inspection at the National plums to retard ripening and spoiling. Archives and Records Administration (d) Sucrose fatty acid esters are used (NARA). For information on the avail- in accordance with current good manu- ability of this material at NARA, call facturing practice and in an amount 202–741–6030, or go to: http:// not to exceed that reasonably required www.archives.gov/federallregister/ to accomplish the intended effect. codeloflfederallregulations/ [47 FR 55475, Dec. 10, 1982, as amended at 48 ibrllocations.html. FR 38226, Aug. 23, 1983; 52 FR 10883, Apr. 6, (2) Chick-edema factor shall be deter- 1987; 53 FR 22294, 22297, June 15, 1988; 54 FR mined by the bioassay method de- 24897, June 12, 1989; 60 FR 44756, Aug. 29, 1995] scribed in ‘‘Official Methods of Anal- ysis of the Association of Official Ana- § 172.860 Fatty acids. lytical Chemists,’’ 13th Ed. (1980), sec- The food additive fatty acids may be tions 28.127–28.130, which is incor- safely used in food and in the manufac- porated by reference. Copies may be ture of food components in accordance obtained from the AOAC INTER- with the following prescribed condi- NATIONAL, 481 North Frederick Ave., tions: suite 500, Gaithersburg, MD 20877, or (a) The food additive consists of one may be examined at the National Ar- or any mixture of the following chives and Records Administration straight-chain monobasic carboxylic (NARA). For information on the avail- acids and their associated fatty acids ability of this material at NARA, call manufactured from fats and oils de- 202–741–6030, or go to: http:// rived from edible sources: Capric acid, www.archives.gov/federallregister/ caprylic acid, lauric acid, myristic codeloflfederallregulations/ acid, oleic acid, palmitic acid, and ste- ibrllocations.html. aric acid. (3) The gas chromatographic-electron (b) The food additive meets the fol- capture method for testing fatty acids lowing specifications: for chick-edema shall be the method (1) Unsaponifiable matter does not described in the ‘‘Journal of the Asso- exceed 2 percent. ciation of Official Analytical Chem- (2) It is free of chick-edema factor: ists,’’ Volume 50 (No. 1), pages 216–218 (i) As evidenced during the bioassay method for determining the chick- (1967), or the modified method using a edema factor as prescribed in para- sulfuric acid clean-up procedure, as de- graph (c)(2) of this section; or scribed in the ‘‘Journal of the Associa- (ii) As evidenced by the absence of tion of the Offical Analytical Chem- chromatographic peaks with a reten- ists,’’ Volume 51 (No. 2), pages 489–490 tion time relative to aldrin (RA) be- (1968), which are incorporated by ref- tween 10 and 25, using the gas erence. See paragraph (c)(2) of this sec- chromatographic-electron capture tion for availability of these ref- method prescribed in paragraph (c)(3) erences. of this section. If chromatographic (d) It is used or intended for use as peaks are found with RA values be- follows: tween 10 and 25, the food additive shall (1) In foods as a lubricant, binder, meet the requirements of the bioassay and as a defoaming agent in accordance method prescribed in paragraph (c)(2) with good manufacturing practice. of this section for determining chick- (2) As a component in the manufac- edema factor. ture of other food-grade additives. (c) For the purposes of this section: (e) To assure safe use of the additive, (1) Unsaponifiable matter shall be de- the label and labeling of the additive termined by the method described in and any premix thereof shall bear, in

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addition to the other information re- used in food and as a component in the quired by the act, the following: manufacture of food-grade additives in (1) The common or usual name of the accordance with the following pre- acid or acids contained therein. scribed conditions: (2) The words ‘‘food grade,’’ in jux- (a) The additive consists of purified taposition with and equally as promi- oleic acid separated from refined tall nent as the name of the acid. oil fatty acids. [42 FR 14491, Mar. 15, 1977, as amended at 47 (b) The additive meets the following FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, specifications: 1984; 54 FR 24897, June 12, 1989] (1) Specifications for oleic acid prescribed in the ‘‘Food Chemicals § 172.861 Cocoa butter substitute from Codex.’’ 3d Ed. (1981), pp. 207–208, which coconut oil, palm kernel oil, or both is incorporated by reference, except oils. that titer (solidification point) shall The food additive, cocoa butter sub- not exceed 13.5 °C and unsaponifiable stitute from coconut oil, palm kernel matter shall not exceed 0.5 percent. oil, or both oils, may be safely used in Copies of the material incorporated by food in accordance with the following reference may be obtained from the conditions: National Academy Press, 2101 Constitu- (a) Cocoa butter substitute from co- tion Ave. NW., Washington, DC 20418, conut oil, palm kernel oil (CAS Reg. or may be examined at the National No. 85665–33–4), or both oils is a mixture Archives and Records Administration of triglycerides. It is manufactured by (NARA). For information on the avail- esterification of glycerol with food- ability of this material at NARA, call grade fatty acids (complying with 202–741–6030, or go to: http:// § 172.860) derived from edible coconut www.archives.gov/federallregister/ oil, edible palm kernel oil, or both oils. codeloflfederallregulations/ (b) The ingredient meets the fol- ibrllocations.html. lowing specifications: (2) The resin acid content does not Acid number: Not to exceed 0.5. exceed 0.01 as determined by ASTM Saponification number: 220 to 260. method D1240–82, ‘‘Standard Test Meth- Iodine number: Not to exceed 3. od for Rosin Acids in Fatty Acids,’’ Melting range: 30 to 44 °C. which is incorporated by reference. (c) The ingredient is used or intended Copies may be obtained from the Amer- for use as follows: ican Society for Testing Materials, 100 (1) As coating material for sugar, Barr Harbor Dr., West Conshohocken, table salt, vitamins, citric acid, suc- Philadelphia, PA 19428-2959, or may be cinic acid, and spices; and examined at the National Archives and (2) In compound coatings, cocoa Records Administration (NARA). For creams, cocoa-based sweets, toffees, information on the availability of this caramel masses, and chewing sweets as material at NARA, call 202–741–6030, or defined in § 170.3 (n)(9) and (n)(38) of go to: http://www.archives.gov/ this chapter, except that the ingredient federallregister/ may not be used in a standardized food codeloflfederallregulations/ unless permitted by the standard of ibrllocations.html. identity. (3) The requirements for absence of (d) The ingredient is used in accord- chick-edema factor as prescribed in ance with current good manufacturing § 172.860. practice and in an amount not to ex- (c) It is used or intended for use as ceed that reasonably required to ac- follows: complish the intended effect. (1) In foods as a lubricant, binder, [56 FR 66970, Dec. 27, 1991; 57 FR 2814, Jan. 23, and defoaming agent in accordance 1992] with good manufacturing practice. (2) As a component in the manufac- § 172.862 Oleic acid derived from tall ture of other food-grade additives. oil fatty acids. (d) To assure safe use of the additive, The food additive oleic acid derived the label and labeling of the additive from tall oil fatty acids may be safely and any premix thereof shall bear, in

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addition to the other information re- (i) Hexyl, octyl, decyl, lauryl, and quired by the Act, the following: myristyl alcohols contain not less than (1) The common or usual name of the 99 percent of total alcohols and not less acid. than 96 percent of straight chain alco- (2) The words ‘‘food grade’’ in jux- hols. Any nonalcoholic impurities are taposition with and equally as promi- primarily paraffins. nent as the name of the acid. (ii) Cetyl and stearyl alcohols con- [42 FR 14491, Mar. 15, 1977, as amended at 49 tain not less than 98 percent of total FR 10105, Mar. 19, 1984] alcohols and not less than 94 percent of straight chain alcohols. Any non- § 172.863 Salts of fatty acids. alcoholic impurities are primarily The food additive salts of fatty acids paraffins. may be safely used in food and in the (iii) The synthetic fatty alcohols con- manufacture of food components in ac- tain no more than 0.1 weight percent of cordance with the following prescribed total diols as determined by a method conditions: available upon request from the Com- (a) The additive consists of one or missioner of Food and Drugs. any mixture of two or more of the alu- (2) Hexyl, octyl, and decyl; manufac- minum, calcium, magnesium, potas- tured by fractional distillation of alco- sium, and sodium salts of the fatty hols obtained by a sequence of oxida- acids conforming with § 172.860 and/or tion, hydrolysis, and catalytic hydro- oleic acid derived from tall oil fatty genation (catalyst consists of copper, acids conforming with § 172.862. chromium, and nickel) of organo-alu- (b) The food additive is used or in- minums generated by the controlled re- tended for use as a binder, emulsifier, action of low molecular weight and anticaking agent in food in accord- trialkylaluminum with purified ethyl- ance with good manufacturing prac- ene (minimum 99 percent by volume tice. C H ), and utilizing an external coolant (c) To assure safe use of the additive, 2 4 such that these alcohols meet the spec- the label and labeling of the additive and any premix thereof shall bear, in ifications prescribed in paragraph (a)(1) addition to the other information re- (i) and (iii) of this section. quired by the Act, the following: (3) n-Octyl; manufactured by the (1) The common or usual name of the hydrodimerization of 1,3-butadiene, fol- fatty acid salt or salts contained there- lowed by catalytic hydrogenation of in. the resulting dienol, and distillation to (2) The words ‘‘food grade,’’ in jux- produce n-octyl alcohol with a min- taposition with and equally as promi- imum purity of 99 percent. The analyt- nent as the name of the salt. ical method for n-octyl alcohol entitled ‘‘Test Method [Normal-octanol]’’ dated § 172.864 Synthetic fatty alcohols. October 2003, and printed by Kuraray Synthetic fatty alcohols may be safe- Co., Ltd., is incorporated by reference. ly used in food and in the synthesis of The Director of the Office of the Fed- food components in accordance with eral Register approves this incorpora- the following prescribed conditions: tion by reference in accordance with 5 (a) The food additive consists of any U.S.C. 552(a) and 1 CFR part 51. You one of the following fatty alcohols: may obtain a copy from the Office of (1) Hexyl, octyl, decyl, lauryl, Food Additive Safety, 5100 Paint myristyl, cetyl, and stearyl; manufac- Branch Pkwy., College Park, MD 20740, tured by fractional distillation of alco- or you may examine a copy at the Cen- hols obtained by a sequence of oxida- ter for Food Safety and Applied Nutri- tion and hydrolysis of organo-alu- tion’s Library, Food and Drug Admin- minums generated by the controlled re- istration, 5100 Paint Branch Pkwy., action of low molecular weight College Park, MD 20740, or at the Na- trialkylaluminum with purified ethyl- tional Archives and Records Adminis- ene (minimum 99 percent by volume tration (NARA). For information on C2H4), and utilizing the hydrocarbon the availability of this material at solvent as defined in paragraph (b) of NARA, call 202–741–6030, or go to http:// this section, such that: www.archives.gov/federallregister/

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codeloflfederallregulations/ vent samples in handling and to assure ab- ibrllocations.html. sence of any extraneous material arising (b) The hydrocarbon solvent used in from inadequate packaging is essential. Be- the process described in paragraph cause some of the polynuclear hydrocarbons sought in this test are very susceptible to (a)(1) of this section is a mixture of liq- photo-oxidation, the entire procedure is to uid hydrocarbons essentially paraffinic be carried out under subdued light. in nature, derived from petroleum and refined to meet the specifications de- APPARATUS scribed in paragraph (b)(1) of this sec- Chromatographic tube. 450 millimeters in tion when subjected to the procedures length (packing section), inside diameter 19 described in paragraph (b) (2) and (3) of millimeters ±1 millimeter, equipped with a this section. wad of clean Pyrex brand filtering wool (Cor- (1) The hydrocarbon solvent meets ning Glass Works Catalog No. 3950 or equivalent). The tube shall contain a 250-milliliter the following specifications: reservoir and a 2-millimeter tetrafluoro- (i) Boiling-point range: 175 °C–275 °C. ethylene polymer stopcock at the opposite (ii) Ultraviolet absorbance limits as end. Overall length of the tube is 670 milli- follows: meters. Stainless steel rod. 2 feet in length, 2 to 4 Maximum millimeters in diameter. absorbance per Vacuum oven. Similar to Labline No. 3610 Wavelength (millicrons) centimeter but modified as follows: A copper tube one- optical fourth inch in diameter and 13 inches in path length length is bent to a right angle at the 4-inch 280–289 ...... 0.15 point and plugged at the opposite end; eight 290–299 ...... 12 copper tubes one-eighth inch in diameter and 300–359 ...... 05 5 inches in length are silver soldered in 360–400 ...... 02 drilled holes (one-eighth inch in diameter) to the one-fourth-inch tube, one on each side at (2) Use ASTM method D86–82, the 5-, 7.5-, 10- and 12.5-inch points; the one- ‘‘Standard Method for Distillation of eighth-inch copper tubes are bent to conform Petroleum Products,’’ which is incor- with the inner periphery of the oven. porated by reference, to determine Beakers. 250-milliliter and 500-milliliter capacity. boiling point range. Copies of the ma- Graduated cylinders. 25-milliliter, 50-milli- terial incorporated by reference may liter, and 150-milliliter capacity. be obtained from the American Society Tuberculin syringe. 1-milliliter capacity, for Testing Materials, 100 Barr Harbor with 3-inch, 22-gauge needle. Dr., West Conshohocken, Philadelphia, Volumetric flask. 5-milliliter capacity. PA 19428-2959, or may be examined at Spectrophotometric cells. Fused quartz the National Archives and Records Ad- ground glass stoppered cells, optical path length in the range of 1.000 centimeter ±0.005 ministration (NARA). For information centimeter. With distilled water in the cells, on the availability of this material at determine any absorbance difference. NARA, call 202–741–6030, or go to: http:// Spectrophotometer. Spectral range 250 milli- www.archives.gov/federallregister/ microns—400 millimicrons with spectral slit codeloflfederallregulations/ width of 2 millimicrons or less: under instru- ibrllocations.html. ment 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 requirements: as follows: Absorbance repeatability, ±0.01 at 0.4 absorbance. GENERAL INSTRUCTIONS Absorbance accuracy, 1 ±0.05 at 0.4 absorb- All glassware should be scrupulously ance. cleaned to remove all organic matter such as oil, grease, detergent residues, etc. Examine 1 As determined by using potassium chro- all glassware, including stoppers and stop- mate for reference standard and described in cocks, under ultraviolet light to detect any National Bureau of Standards Circular 484, residual fluorescent contamination. As a pre- Spectrophotometry, U.S. Department of cautionary measure, it is recommended prac- Commerce, (1949). The accuracy is to be de- tice to rinse all glassware with purified iso- termined by comparison with the standard octane immediately before use. No grease is values at 290, 345, and 400 millimicrons. Cir- to be used on stopcocks or joints. Great care cular 484 is incorporated by reference. Copies to avoid contamination of hydrocarbon sol- Continued

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Wavelength repeatability, ±0.2 milliequivalent). Use 20 milliliters for test. If nec- micron. essary, 1,2-dichloroethane may be purified by Wavelength accuracy, ±1.0 millimicron. distillation. Nitrogen cylinder. Water-pumped or equiva- Eluting mixtures: lent purity nitrogen in cylinder equipped 1. 10 percent 1,2-dichloroethane in hexane. with regulator and valve to control flow at 5 Pipet 100 milliliters of 1,2-dichloroethane p.s.i.g. into a 1-liter glass-stoppered volumetric flask and adjust to volume with hexane, with REAGENTS AND MATERIALS mixing. Organic solvents. All solvents used through- 2. 40 percent benzene in hexane. Pipet 400 out the procedure shall meet the specifica- milliliters of benzene into a 1-liter glass- tions and tests described in this specifica- stoppered volumetric flask and adjust to vol- tion. The isooctane, benzene, hexane, and 1,2- ume with hexane, with mixing. dichloroethane designated in the list fol- n-Hexadecane, 99 percent olefin-free. Dilute lowing this paragraph shall pass the fol- 1.0 milliliter of n-hexadecane to 5 milliliters lowing test: with isooctane and determine the absorbance To the specified quantity of solvent in a in a 1-centimeter cell compared to isooctane 250-milliliter beaker, add 1 milliliter of puri- as reference between 280 mμ-400mμ. The ab- fied n-hexadecane and evaporate in the vacu- sorbance per centimeter path length shall um oven under a stream of nitrogen. Dis- not exceed 0.00 in this range. If necessary, n- continue evaporation when not over 1 milli- hexadecane may be purified by percolation liter of residue remains. (To the residue from through activated silica gel or by distilla- benzene add a 5-milliliter portion of purified tion. isooctane, reevaporate, and repeat once to Silica gel, 28–200 mesh (Grade 12, Davison insure complete removal of benzene.) Chemical Co., Baltimore, Md., or equivalent). Dissolve the 1 milliliter of hexadecane res- Activate as follows: Weigh about 900 grams idue in isooctane and make to 5 milliliters into a 1-gallon bottle, add 100 milliliters of volume. Determine the absorbance in the 1- de-ionized water, seal the bottle and shake centimeter path length cells compared to and roll at intervals for 1 hour. Allow to isooctane as reference. The absorbance of the equilibrate overnight in the sealed bottle. solution of the solvent residue shall not ex- Activate the gel at 150 °C for 16 hours, in a ceed 0.02 per centimeter path length between 2-inch × 7-inch × 12-inch porcelain pan loose- 280 and 300 mμ and shall not exceed 0.01 per ly covered with aluminum foil, cool in a centimeter path length between 300 and 400 dessicator, transfer to a bottle and seal. mμ. Isooctane (2,2,4-trimethylpentane). Use 10 PROCEDURE milliliters for the test described in the pre- Determination of ultraviolet absorbance. Be- ceding paragraph. If necessary, isooctane fore proceeding with the analysis of a sample may be purified by passage through a column determine the absorbance in a 1-centimeter of activated silica gel (Grade 12, Davison path cell for the reagent blank by carrying Chemical Co., Baltimore, Md., or equiva- out the procedure without a sample. Record lent). the absorbance in the wavelength range of Benzene, spectro grade (Burdick and Jackson 280 to 400 millimicrons. Typical reagent Laboratories, Inc., Muskegon, Mich., or equiva- blank absorbance in this range should not lent). Use 80 milliliters for the test. If nec- exceed 0.04 in the 280 to 299 millimicron essary, benzene may be purified by distilla- range, 0.02 in the 300 to 359 millimicron tion or otherwise. range, and 0.01 in the 360 to 400 millimicron Hexane, spectro grade (Burdick and Jackson range. If the characteristic benzene peaks in Laboratories, Inc., Muskegon, Mich., or equiva- the 250 to 260 millimicron region are present, lent). Use 650 milliliters for the test. If nec- remove the benzene by the procedure de- essary, hexane may be purified by distilla- scribed above under ‘‘Reagents and Mate- tion or otherwise. rials,’’ ‘‘Organic Solvents,’’ and record ab- 1,2-Dichloroethane, spectro grade (Matheson, sorbance again. Coleman, and Bell, East Rutherford, N.J., or Transfer 50 grams of silica gel to the chromatographic tube for sample analysis. are available from the Center for Food Safe- Raise and drop the column on a semisoft, ty and Applied Nutrition (HFS–200), Food clean surface for about 1 minute to settle the and Drug Administration, 5100 Paint Branch gel. Pour 100 milliliters of hexane into the Pkwy., College Park, MD 20740, or available column with the stopcock open and allow to for inspection at the National Archives and drain to about one-half inch above the gel. Records Administration (NARA). For infor- Turn off the stopcock and allow the column mation on the availability of this material to cool for 30 minutes. After cooling, vibrate at NARA, call 202–741–6030, or go to: http:// the column to eliminate air and stir the top www.archives.gov/federallregister/ 1 to 2 inches with a small diameter stainless codeloflfederallregulations/ steel rod. Take care not to get the gel above ibrllocations.html. the liquid and onto the sides of the column.

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Weigh out 40 grams ±0.1 gram of the hydro- cohols used as intermediates in the carbon solvent sample into a 250-milliliter synthesis of food additives and other beaker, add 50 milliliters of hexane, and pour substances permitted in food. the solution into the column. Rinse the beaker with 50 milliliters of hexane and add [42 FR 14491, Mar. 15, 1977, as amended at 47 this to the column. Allow the hexane sample FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, solution to elute into a 500-milliliter beaker 1984; 54 FR 24897, June 12, 1989; 70 FR 72908, until the solution is about one-half inch Dec. 8, 2005] above the gel. Rinse the column three times with 50-milliliter portions of hexane. Allow § 172.866 Synthetic glycerin produced each hexane rinse to separately elute to by the hydrogenolysis of carbo- about one-half inch above the gel. Replace hydrates. the eluate beaker (discard the hexane eluate) with a 250-milliliter beaker. Add two sepa- Synthetic glycerin produced by the rate 25-milliliter portions of 10 percent 1,2- hydrogenolysis of carbohydrates may dichloroethane and allow each to separately be safely used in food, subject to the elute as before. Finally, add 150 milliliters of provisions of this section: 10 percent 1,2-dichloroethane for a total of 200 milliliters. When the final 10 percent 1,2- (a) It shall contain not in excess of dichloroethane fraction is about one-half 0.2 percent by weight of a mixture of inch above the top of the gel bed, replace the butanetriols. receiving beaker (discard the 1,2- (b) It is used or intended for use in an dichloroethane eluate) with a 250-milliliter amount not to exceed that reasonably beaker containing 1 milliliter of hexadecane. required to produce its intended effect. Adjust the elution rate to 2 to 3 milliliters per minute, add two 25-milliliter portions of 40 percent benzene and allow each to sepa- § 172.867 Olestra. rately elute as before to within about one- Olestra, as identified in this section, half inch of the gel bed. Finally, add 150 mil- may be safely used in accordance with liliters of 40 percent benzene for a total of 200 milliliters. Evaporate the benzene in the the following conditions: oven with vacuum and sufficient nitrogen (a) Olestra is a mixture of octa-, flow to just ripple the top of the benzene so- hepta-, and hexa-esters of sucrose with lution. When the benzene is removed (as de- fatty acids derived from edible fats and termined by a constant volume of hexa- oils or fatty acid sources that are gen- decane) add 5 milliliters of isooctane and erally recognized as safe or approved evaporate. Repeat once to insure complete for use as food ingredients. The chain removal of benzene. Remove the beaker and cover with aluminum foil (previously rinsed lengths of the fatty acids are no less with hexane) until cool. than 12 carbon atoms. Quantitatively transfer the hexadecane (b) Olestra meets the specifications residue to a 5-milliliter volumetric flask and of the Food Chemicals Codex, 4th edi- dilute to volume with isooctane. Determine tion, 1st supplement (1997), pp. 33–35, the absorbance of the solution in 1-centi- which is incorporated by reference. The meter path length cells between 280 and 400 Director of the Office of the Federal millimicrons using isooctane as a reference. Correct the absorbance values for any ab- Register approves this incorporation sorbance derived from reagents as deter- by reference in accordance with 5 mined by carrying out the procedure without U.S.C. 552(a) and 1 CFR part 51. You a sample. If the corrected absorbance does may obtain copies from the National not exceed the limits prescribed in para- Academy Press, 2101 Constitution Ave. graph (b)(1)(ii) of this section, the sample NW., Washington, DC 20418 (Internet meets the ultraviolet absorbance specifica- address http://www.nap.edu). Copies tions for hydrocarbon solvent. may be examined at the Center for (c) Synthetic fatty alcohols may be Food Safety and Applied Nutrition’s used as follows: Library, Food and Drug Administra- (1) As substitutes for the cor- tion, 5100 Paint Branch Pkwy., College responding naturally derived fatty al- Park, MD 20740, or at the National Ar- cohols permitted in food by existing chives and Records Administration regulations in this part or part 173 of (NARA). For information on the avail- this chapter provided that the use is in ability of this material at NARA, call compliance with any prescribed limita- 202–741–6030, or go to: http:// tions. www.archives.gov/federallregister/ (2) As substitutes for the cor- codeloflfederallregulations/ responding naturally derived fatty al- ibrllocations.html.

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(c) Olestra may be used in place of taining on an anhydrous basis not more fats and oils in prepackaged ready-to- than 2.6 ethoxy groups per eat savory (i.e., salty or piquant but anhydroglucose unit. not sweet) snacks and prepackaged, (b) It is used or intended for use as unpopped popcorn kernels that are follows: ready-to-heat. In such foods, the addi- (1) As a binder and filler in dry vita- tive may be used in place of fats and min preparations. oils for frying or baking, in dough con- (2) As a component of protective ditioners, in sprays, in filling ingredi- coatings for vitamin and mineral tab- ents, or in flavors. lets. (d) To compensate for any inter- (3) As a fixative in flavoring com- ference with absorption of fat soluble pounds. vitamins, the following vitamins shall be added to foods containing olestra: § 172.869 Sucrose oligoesters. 1.9 milligrams alpha-tocopherol equivalents per gram olestra; 51 retinol Sucrose oligoesters, as identified in equivalents per gram olestra (as this section, may be safely used in ac- retinyl acetate or retinyl palmitate); 12 cordance with the following conditions: IU vitamin D per gram olestra; and 8 μg (a) Sucrose oligoesters consist of vitamin K1 per gram olestra. mixtures of sucrose fatty acid esters (e)(1) Vitamins A, D, E, and K present with an average degree of in foods as a result of the requirement esterification ranging from four to in paragraph (d) of this section shall be seven. It is produced by declared in the listing of ingredients. interesterification of sucrose with Such vitamins shall not be considered methyl esters of fatty acids derived in determining nutrient content for the from edible fats and oils (including hy- nutritional label or for any nutrient drogenated fats and oils). The only sol- claims, express or implied. vents which may be used in the prepa- (i) An asterisk shall follow vitamins ration of sucrose oligoesters are di- A, D, E, and K in the listing of ingredi- methyl sulfoxide, isobutyl alcohol, and ents; those solvents generally recognized as (ii) The asterisk shall appear as a su- safe in food. perscript following each vitamin; (b) Sucrose oligoesters meet the spec- (iii) Immediately following the ingre- ifications in the methods listed in the dient list an asterisk and statement, table in this paragraph. The methods ‘‘Dietarily insignificant’’ shall appear cited for determining compliance with prominently and conspicuously as spec- each specification are incorporated by ified in § 101.2(c) of this chapter; reference, in accordance with 5 U.S.C. (2) Olestra shall not be considered as 552(a) and 1 CFR part 51. Copies of the a source of fat or calories for purposes methods may be examined at the Cen- of §§ 101.9 and 101.13 of this chapter. ter for Food Safety and Applied Nutri- [61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, tion’s Library, room 1C–100, 5100 Paint 1996, as amended at 68 FR 46402, Aug. 5, 2003; Branch Pkwy., College Park, MD 20740, 69 FR 29432, May 24, 2004] or at the National Archives and Records Administration (NARA). For § 172.868 Ethyl cellulose. information on the availability of this The food additive ethyl cellulose may material at NARA, call 202–741–6030, or be safely used in food in accordance go to: http://www.archives.gov/ with the following prescribed condi- federallregister/ tions: codeloflfederallregulations/ (a) The food additive is a cellulose ibrllocations.html. Copies of the meth- ether containing ethoxy (OC2H5) groups ods are available from the sources list- attached by an ether linkage and con- ed in the table in this paragraph:

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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, 5100 Paint Branch Pkwy., 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.

(6) Acid Value ...... Not more than 4.0 ...... ‘‘Acid Value,’’ Appendix VII, National Academy Press, Method I (Commercial Fatty 2101 Constitution Ave. NW, Acids), in the Food Chemi- Washington, DC 20418 cals Codex, 4th ed. (1996), (Internet: http:// p. 820. www.nap.edu).

(7) Residue on Ignition ...... Not more than 0.7% ...... ‘‘Residue on Ignition, Appen- Do. dix IIC, Method I, in the Food Chemicals Codex, 4th ed. (1996), pp. 751–752, (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 First Supplement to the 4th ed. of the Food Chemicals Codex (1997), pp. 44–45.

(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. Spectrophotometric Graph- ite Furnace Method,’’ Meth- od I, in the Food Chemicals Codex, 4th ed. (1996), pp. 763–765.

(c) The additive is used as an emulsi- § 172.870 Hydroxypropyl cellulose. fier (as defined in § 170.3(o)(8) of this The food additive hydroxypropyl cel- chapter) or stabilizer (as defined in lulose may be safely used in food, ex- § 170.3(o)(28) of this chapter) in choco- cept standardized foods that do not late and in butter-substitute spreads, provide for such use, in accordance at a level not to exceed 2.0 percent; ex- with the following prescribed condi- cept that the additive may not be used tions: in a standardized food unless permitted (a) The additive consists of one of the by the standard of identity. following: (1) A cellulose ether containing pro- [68 FR 50072, Aug. 20, 2003] pylene glycol groups attached by an ether linkage that contains, on an anhydrous basis, not more than 4.6

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hydroxypropyl groups per (2) The viscosity of an aqueous solu- anhydroglucose unit. The additive has tion, 2.5 grams of the material in 100 a minimum viscosity of 10 centipoises milliliters of water, at 20 °C, is 20 to 60 for a 10 percent by weight aqueous so- centipoises. lution at 25 degrees C. (3) The ash content on a dry basis has (2) A cellulose ether containing pro- a maximum of 0.6 percent. pylene glycol groups attached by an (c) The food additive is used as an ether linkage having a hydroxypropoxy aerating, emulsifying, and foaming (OC3H6OH) content of 5 to 16 percent agent, in an amount not in excess of weight in weight (w/w) on an anhydrous that reasonably required to produce its basis, i.e., 0.1 to 0.4 hydroxypropyl intended effect. groups per anhydroglucose unit. The common name for this form of the ad- § 172.874 Hydroxypropyl ditive is low substituted hydroxypropyl methylcellulose. cellulose. The food additive hydroxypropyl (b) The additive is used or intended methylcellulose (CAS Reg. No. 9004–65– for use as follows: 3) may be safely used in food, except in (1) The additive identified in para- standardized foods which do not pro- graph (a)(1) of this section is used or vide for such use if: intended for use as an emulsifier, film (a) The additive complies with the former, protective colloid, stabilizer, definition and specifications prescribed suspending agent, or thickener in food, in the National Formulary, 12th edi- in accordance with good manufacturing practice. The additive also may be used tion. as a binder in dietary supplements, in (b) It is used or intended for use as an accordance with good manufacturing emulsifier, film former, protective col- practice. loid, stabilizer, suspending agent, or (2) The additive identified in para- thickener, in accordance with good graph (a)(2) of this section is used or manufacturing practice. intended for use as a binder and dis- (c) To insure safe use of the additive, integrator in tablets or wafers con- the container of the additive, in addi- taining dietary supplements of vita- tion to being labeled as required by the mins and/or minerals. The additive is general provisions of the act, shall be used in accordance with good manufac- accompanied by labeling which con- turing practice. tains adequate directions for use to provide a final product that complies [46 FR 50065, Oct. 9, 1981, as amended at 76 FR with the limitations prescribed in para- 41689, July 15, 2011] graph (b) of this section. § 172.872 Methyl ethyl cellulose. [42 FR 14491, Mar. 15, 1977, as amended at 47 The food additive methyl ethyl cel- FR 38273, Aug. 31, 1982] lulose may be safely used in food in accordance with the following prescribed § 172.876 Castor oil. conditions. The food additive castor oil may be (a) The additive is a cellulose ether safely used in accordance with the fol- having the general formula lowing conditions: [C6H(10-x-y)O5(CH3)x(C2H5)y]n, where x is (a) The additive meets the specifica- the number of methyl groups and y is tions of the United States Pharma- the number of ethyl groups. The aver- copeia XX (1980). age value of x is 0.3 and the average (b) The additive is used or intended value of y is 0.7. for use as follows: (b) The additive meets the following specifications: Use and Limitations (1) The methoxy content shall be not Hard candy production—As a release agent less than 3.5 percent and not more than and antisticking agent, not to exceed 500 6.5 percent, calculated as OCH3, and the parts per million in hard candy. ethoxy content shall be not less than Vitamin and mineral tablets—As a compo- 14.5 percent and not more than 19 per- nent of protective coatings. cent, calculated as OC2H5, both meas- [42 FR 14491, Mar. 15, 1977, as amended at 49 ured on the dry sample. FR 10105, Mar. 19, 1984]

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§ 172.878 White mineral oil. any absorbance due to added antioxidants. Copies of the material incor- White mineral oil may be safely used porated by reference are available from in food in accordance with the fol- the Center for Food Safety and Applied lowing conditions: Nutrition (HFS–200), Food and Drug (a) White mineral oil is a mixture of Administration, 5100 Paint Branch liquid hydrocarbons, essentially par- Pkwy., College Park, MD 20740, or affinic and naphthenic in nature ob- available for inspection at the National tained from petroleum. It is refined to Archives and Records Administration meet the following specifications: (NARA). For information on the avail- (1) It meets the test requirements of ability of this material at NARA, call the United States Pharmacopeia XX 202–741–6030, or go to: http:// (1980) for readily carbonizable sub- www.archives.gov/federallregister/ stances (page 532). codeloflfederallregulations/ (2) It meets the test requirements of ibrllocations.html. U.S.P. XVII for sulfur compounds (page (b) White mineral oil may contain 400). any antioxidant permitted in food by (3) It meets the specifications pre- regulations issued in accordance with scribed in the ‘‘Journal of the Associa- section 409 of the Act, in an amount tion of Official Analytical Chemists,’’ not greater than that required to Volume 45, page 66 (1962), which is in- produce its intended effect. corporated by reference, after correc- (c) White mineral oil is used or in- tion of the ultraviolet absorbance for 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]

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§ 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. 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 320–329 millimicrons—0.08 maximum. antioxidant permitted in food by regu- 330–350 millimicrons—0.05 maximum. lations issued in accordance with sec- Nonvolatile residual: 0.002 gram per 100 tion 409 of the Act, in an amount not milliliters maximum. greater than that required to produce Synthetic isoparaffinic petroleum hydro- its intended effect. carbons containing antioxidants shall meet the specified ultraviolet absorbance limits [42 FR 14491, Mar. 15, 1977, as amended at 49 after correction for any absorbance due to FR 10105, Mar. 19, 1984] the antioxidants. The ultraviolet absorbance shall be determined by the procedure de- § 172.882 Synthetic isoparaffinic petro- scribed for application of mineral oil, dis- leum hydrocarbons. regarding the last sentence of the procedure, under ‘‘Specifications’’ on page 66 of the Synthetic isoparaffinic petroleum ‘‘Journal of the Association of Official Ana- hydrocarbons may be safely used in lytical Chemists,’’ Volume 45 (February food, in accordance with the following 1962), which is incorporated by reference. conditions: Copies are available from the Center for (a) They are produced by synthesis Food Safety and Applied Nutrition (HFS– from petroleum gases and consist of a 200), Food and Drug Administration, 5100 mixture of liquid hydrocarbons meet- Paint Branch Pkwy., College Park, MD 20740, ing the following specifications: or available for inspection at the National Archives and Records Administration Boiling point 93–260 °C as determined by (NARA). For information on the availability ASTM method D86–82, ‘‘Standard Method for of this material at NARA, call 202–741–6030, Distillation of Petroleum Products,’’ which or go to: http://www.archives.gov/ is incorporated by reference. Copies may be federallregister/codeloflfederallregulations/ obtained from the American Society for ibrllocations.html. For hydrocarbons boiling Testing Materials, 100 Barr Harbor Dr., West below 250 °F, the nonvolatile residue shall be Conshohocken, Philadelphia, PA 19428-2959, determined by ASTM method D1353–78, or may be examined at the National Ar- ‘‘Standard Test Method for Nonvolatile Mat- chives and Records Administration (NARA). ter in Volatile Solvents for Use in Paint, For information on the availability of this Varnish, Lacquer, and Related Products;’’ material at NARA, call 202–741–6030, or go to: for those boiling above 121 °C, ASTM method http://www.archives.gov/federallregister/ D381–80, ‘‘Standard Test Method for Existent codeloflfederallregulations/ Gum in Fuels by Jet Evaporation’’ shall be ibrllocations.html. used. These methods are incorporated by ref- Ultraviolet absorbance: erence. Copies may be obtained from the 260–319 millimicrons—1.5 maximum. American Society for Testing Materials, 100

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Barr Harbor Dr., West Conshohocken, Phila- § 178.3620(b)(1)(ii) of this chapter, as fol- delphia, PA 19428-2959, or may be examined lows: at the National Archives and Records Ad- ministration (NARA). For information on Maximum the availability of this material at NARA, absorb- call 202–741–6030, or go to: http:// μ ance per Wavelength m centimeter www.archives.gov/federallregister/ optical codeloflfederallregulations/ pathlength ibrllocations.html. 280–289 ...... 4.0 (b) Isoparaffinic petroleum hydro- 290–299 ...... 3.3 carbons may contain antioxidants au- 300–329 ...... 2.3 thorized for use in food in an amount 330–360 ...... 8 not to exceed that reasonably required to accomplish the intended technical (c) The additive is used as follows: effect nor to exceed any prescribed lim- Use Limitations itations. (c) Synthetic isoparaffinic petroleum As a coating on shell eggs ...... In an amount not to ex- hydrocarbons are used or intended for ceed good manufac- use as follows: turing practice. As a defoamer in processing beet Complying with sugar and yeast. § 173.340 of this chap- Uses Limitations ter. 1. In the froth-flotation cleaning of In an amount not to ex- As a float on fermentation fluids in In an amount not to ex- vegetables. ceed good manufac- the manufacture of vinegar and ceed good manufacturing practice. wine to prevent or retard ac- turing practice. 2. As a component of insecticide Do. cess of air, evaporation, and formulations for use on proc- wild yeast contamination during essed foods. fermentation. 3. As a component of coatings on Do. In the froth-flotation cleaning of Do. fruits and vegetables. vegetables. 4. As a coating on shell eggs ...... Do. As a component of insecticide for- Do. 5. As a float on fermentation Do. mulations used in compliance fluids in the manufacture of vin- with regulations issued in parts egar and wine and on brine 170 through 189 of this chapter. used in curing pickles, to prevent or retard access of air, evaporation, and contamination § 172.886 Petroleum wax. with wild organisms during fermentation. 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 nature, derived from petroleum, and re- § 172.884 Odorless light petroleum hy- fined to meet the specifications pre- drocarbons. scribed 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 or synthesized from petroleum gases. ultraviolet absorb- The additive is chiefly paraffinic, ance per isoparaffinic, or naphthenic in nature. centimeter path length (b) The additive meets the following specifications: 280–289 millimicrons ...... 0.15 (1) Odor is faint and not kerosenic. 290–299 millimicrons ...... 0.12 (2) Initial boiling point is 300 °F min- 300–359 millimicrons ...... 0.08 imum. 360–400 millimicrons ...... 0.02 (3) Final boiling point is 650 °F maximum. (4) Ultraviolet absorbance limits determined by method specified in

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ANALYTICAL SPECIFICATION FOR PETROLEUM Vigreaux vacuum-jacketed condenser (or WAX equivalent) about 45 centimeters in length and distilling head with separable cold finger GENERAL INSTRUCTIONS condenser. Use of tetrafluoroethylene poly- Because of the sensitivity of the test, the mer sleeves on the glass joints will prevent possibility of errors arising from contamina- freezing. Do not use grease on stopcocks or tion is great. It is of the greatest importance joints. that all glassware be scrupulously cleaned to Spectrophotometric cells. Fused quartz cells, remove all organic matter such as oil, optical path length in the range of 5.000 cen- ± grease, detergent residues, etc. Examine all timeters 0.005 centimeter; also for checking glassware, including stoppers and stopcocks, spectrophotometer performance only, optical under ultraviolet light to detect any residual path length in the range 1.000 centimeter ± fluorescent contamination. As a pre- 0.005 centimeter. With distilled water in the cautionary measure it is recommended prac- cells, determine any absorbance differences. tice to rinse all glassware with purified iso- Spectrophotometer. Spectral range 250 milli- octane immediately before use. No grease is microns–400 millimicrons with spectral slit to be used on stopcocks or joints. Great care width of 2 millimicrons or less, under instru- to avoid contamination of wax samples in ment operating conditions for these absorb- handling and to assure absence of any extra- ance measurements, the spectrophotometer neous material arising from inadequate shall also meet the following performance packaging is essential. Because some of the requirements: ± polynuclear hydrocarbons sought in this test Absorbance repeatability, 0.01 at 0.4 ab- are very susceptible to photo-oxidation, the sorbance. 1 ± entire procedure is to be carried out under Absorbance accuracy, 0.05 at 0.4 absorb- subdued light. ance. Wavelength repeatability, ±0.2 milli- APPARATUS micron. Wavelength accuracy, ±1.0 millimicron. Separatory funnels. 250–milliliter, 500–milli- Nitrogen cylinder. Water-pumped or equiva- liter, 1,000–milliliter, and preferably 2,000– lent purity nitrogen in cylinder equipped milliliter capacity, equipped with tetra- with regulator and valve to control flow at 5 fluoroethylene polymer stopcocks. p.s.i.g. Reservoir. 500–milliliter capacity, equipped with a 24/40 standard taper male fitting at REAGENTS AND MATERIALS the bottom and a suitable ball-joint at the Organic solvents. All solvents used through- top for connecting to the nitrogen supply. out the procedure shall meet the specifica- The male fitting should be equipped with tions and tests described in this specifica- glass hooks. tion. The isooctane, benzene, acetone, and Chromatographic tube. 180 millimeters in methyl alcohol designated in the list fol- length, inside diameter to be 15.7 millimeters lowing this paragraph shall pass the fol- ±0.1 millimeter, equipped with a coarse, frit- lowing test: ted-glass disc, a tetrafluoroethylene polymer To the specified quantity of solvent in a stopcock, and a female 24/40 standard tapered 250–milliliter Erlenmeyer flask, add 1 milli- fitting at the opposite end. (Overall length of liter of purified n-hexadecane and evaporate the column with the female joint is 235 million the steam bath under a stream of nitro- meters.) The female fitting should be gen (a) loose aluminum foil jacket around equipped with glass hooks. Disc. Tetrafluoroethylene polymer 2–inch 1 diameter disc approximately 3⁄16–inch thick As determined by using potassium chro- with a hole bored in the center to closely fit mate for reference standard and described in the stem of the chromatographic tube. National Bureau of Standards Circular 484, Heating jacket. Conical, for 500–milliliter Spectrophotometry, U.S. Department of separatory funnel. (Used with variable trans- Commerce, (1949). The accuracy is to be de- former heat control.) termined by comparison with the standard Suction flask. 250–milliliter or 500–milliliter values at 290, 345, and 400 millimicrons. Cir- filter flask. cular 484 is incorporated by reference. Copies Condenser. 24/40 joints, fitted with a drying are available from the Center for Food Safe- tube, length optional. ty and Applied Nutrition (HFS–200), Food Evaporation flask (optional). 250–milliliter and Drug Administration, 5100 Paint Branch or 500–milliliter capacity all-glass flask Pkwy., College Park, MD 20740, or available equipped with standard taper stopper having for inspection at the National Archives and inlet and outlet tubes to permit passage of Records Administration (NARA). For infor- nitrogen across the surface of contained liq- mation on the availability of this material uid to be evaporated. at NARA, call 202–741–6030, or go to: http:// Vacuum distillation assembly. All glass (for www.archives.gov/federallregister/ purification of dimethyl sulfoxide); 2–liter codeloflfederallregulations/ distillation flask with heating mantle; ibrllocations.html.

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the flask will speed evaporation). Dis- milliliters of distilled water in a 500–milli- continue evaporation when not over 1 milliliter separatory funnel, mix and allow to liter of residue remains. (To the residue from cool for 5–10 minutes. Add 40 milliliters of benzene add a 10–milliliter portion of puri- isooctane to the solution and extract by fied isooctane, reevaporate, and repeat once shaking the funnel vigorously for 2 minutes. to insure complete removal of benzene.) Draw off the lower aqueous layer into a sec- Alternatively, the evaporation time can be ond 500–milliliter separatory funnel and re- reduced by using the optional evaporation peat the extraction with 40 milliliters of iso- flask. In this case the solvent and n-hexa- octane. Draw off and discard the aqueous decane are placed in the flask on the steam layer. Wash each of the 40–milliliter extrac- bath, the tube assembly is inserted, and a tives three times with 50–milliliter portions stream of nitrogen is fed through the inlet of distilled water. Shaking time for each tube while the outlet tube is connected to a wash is 1 minute. Discard the aqueous lay- solvent trap and vacuum line in such a way ers. Filter the first extractive through anhy- as to prevent any flow-back of condensate drous sodium sulfate prewashed with iso- into the flask. octane (see Sodium sulfate under ‘‘Reagents Dissolve the 1 milliliter of hexadecane res- and Materials’’ for preparation of filter), into idue in isooctane and make to 25 milliliters a 250–milliliter Erlenmeyer flask, or option- volume. Determine the absorbance in the 5– ally into the evaporating flask. Wash the centimeter path length cells compared to first separatory funnel with the second 40– isooctane as reference. The absorbance of the milliliter isooctane extractive, and pass solution of the solvent residue (except for through the sodium sulfate into the flask. methyl alcohol) shall not exceed 0.01 per cen- Then wash the second and first separatory timeter path length between 280 and 400 mμ. funnels successively with a 10–milliliter por- For methyl alcohol this absorbance value tion of isooctane, and pass the solvent shall be 0.00. through the sodium sulfate into the flask. Isooctane (2,2,4–trimethylpentane). Use 180 Add 1 milliliter of n-hexadecane and evapo- milliliters for the test described in the pre- rate the isooctane on the steam bath under ceding paragraph. Purify, if necessary, by nitrogen. Discontinue evaporation when not passage through a column of activated silica over 1 milliliter of residue remains. To the gel (Grade 12, Davison Chemical Company, residue, add a 10–milliliter portion of iso- Baltimore, Maryland, or equivalent) about 90 octane and reevaporate to 1 milliliter of 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

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filtrate to a 2–liter separatory funnel and per centimeter path length between 280 mμ draw off the dimethyl sulfoxide into the 2– and 400 mμ when tested as prescribed under liter distillation flask of the vacuum dis- ‘‘Organic solvents.’’ Usually three portions tillation assembly and distill at approxi- of wash solvent are sufficient. mately 3–millimeter Hg pressure or less. Dis- Before proceeding with analysis of a sam- card the first 200–milliliter fraction of the ple, determine the absorbance in a 5–centi- distillate and replace the distillate collec- meter path cell between 250 mμ and 400 mμ tion flask with a clean one. Continue the dis- for the reagent blank by carrying out the tillation until approximately 1 liter of the procedure, without a wax sample, at room sulfoxide has been collected. temperature, recording the spectra after the At completion of the distillation, the rea- extraction stage and after the complete pro- gent should be stored in glass-stoppered bot- cedure as prescribed. The absorbance per tles since it is very hygroscopic and will centimeter path length following the extrac- react with some metal containers in the tion stage should not exceed 0.040 in the presence of air. wavelength range from 280 mμ to 400 mμ; the Phosphoric acid. 85 percent A.C.S. reagent absorbance per centimeter path length fol- grade. lowing the complete procedure should not Sodium borohydride. 98 percent. exceed 0.070 in the wavelength range from 280 Magnesium oxide (Sea Sorb 43, Food Machin- mμ to 299 mμ, inclusive, nor 0.045 in the ery Company, Westvaco Division, distributed by wavelength range from 300 mμ to 400 mμ. If in chemical supply firms, or equivalent). Place 100 either spectrum the characteristic benzene grams of the magnesium oxide in a large peaks in the 250 mμ–260 mμ region are beaker, add 700 milliliters of distilled water present, remove the benzene by the proce- to make a thin slurry, and heat on a steam dure under ‘‘Organic solvents’’ and record bath for 30 minutes with intermittent stir- absorbance again. ring. Stir well initially to insure that all the absorbent is completely wetted. Using a Place 300 milliliters of dimethyl sulfoxide Buchner funnel and a filter paper (Schleicher in a 1–liter separatory funnel and add 75 mil- & Schuell No. 597, or equivalent) of suitable liliters of phosphoric acid. Mix the contents diameter, filter with suction. Continue suc- of the funnel and allow to stand for 10 min- tion until water no longer drips from the utes. (The reaction between the sulfoxide funnel. Transfer the absorbent to a glass and the acid is exothermic. Release pressure trough lined with aluminum foil (free from after mixing, then keep funnel stoppered.) rolling oil). Break up the magnesia with a Add 150 milliliters of isooctane and shake to clean spatula and spread out the absorbent preequilibrate the solvents. Draw off the in- on the aluminum foil in a layer about 1 cen- dividual layers and store in glass-stoppered timeter to 2 centimeters thick. Dry for 24 flasks. hours at 160 °C ±1 °C. Pulverize the magnesia Place a representative 1–kilogram sample with mortar and pestle. Sieve the pulverized of wax, or if this amount is not available, the absorbent between 60–180 mesh. Use the mag- entire sample, in a beaker of a capacity nesia retained on the 180–mesh sieve. about three times the volume of the sample Celite 545. Johns-Manville Company, diato- and heat with occasional stirring on a steam maceous earth, or equivalent. bath until the wax is completely melted and Magnesium oxide-Celite 545 mixture (2+ 1) by homogeneous. Weigh four 25–gram ±0.2 gram weight. Place the magnesium oxide (60–180 portions of the melted wax in separate 100– mesh) and the Celite 545 in 2 to 1 propor- milliliter beakers. Reserve three of the portions, respectively, by weight in a glass- tions for later replicate analyses as nec- stoppered flask large enough for adequate essary. Pour one weighed portion imme- mixing. Shake vigorously for 10 minutes. diately after remelting (on the steam bath) Transfer the mixture to a glass trough lined into a 500–milliliter separatory funnel con- with aluminum foil (free from rolling oil) taining 100 milliliters of the preequilibrated and spread it out on a layer about 1 centi- sulfoxide-phosphoric acid mixture that has meter to 2 centimeters thick. Reheat the been heated in the heating jacket at a tem- mixture at 160 °C ±1 °C for 2 hours, and store perature just high enough to keep the wax in a tightly closed flask. melted. (NOTE: In preheating the sulfoxide- Sodium sulfate, anhydrous, A.C.S. reagent acid mixture, remove the stopper of the sepa- grade, preferably in granular form. For each ratory funnel at intervals to release the bottle of sodium sulfate reagent used, estab- pressure.) lish as follows the necessary sodium sulfate Promptly complete the transfer of the prewash to provide such filters required in sample to the funnel in the jacket with por- the method: Place approximately 35 grams of tions of the preequilibrated isooctane, warm- anhydrous sodium sulfate in a 30–milliliter ing the beaker, if necessary, and using a coarse, fritted-glass funnel or in a 65–milli- total volume of just 50 milliliters of the sol- meter filter funnel with glass wool plug; vent. If the wax comes out of solution during wash with successive 15–milliliter portions of these operations, let the stoppered funnel re- the indicated solvent until a 15–milliliter main in the jacket until the wax redissolves. portion of the wash shows 0.00 absorbance (Remove stopper from the funnel at intervals

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to release pressure.) When the wax is in solu- to lose none of the solution in filling the tion, remove the funnel from the jacket and sample cell). Correct the absorbance values shake it vigorously for 2 minutes. Set up for any absorbance derived from reagents as three 250–milliliter separatory funnels with determined by carrying out the procedure each containing 30 milliliters of without a wax sample. If the corrected ab- preequilibrated isooctane. After separation sorbance does not exceed the limits pre- of the liquid phases, allow to cool until the scribed in this paragraph (b), the wax meets main portion of the wax-isooctane solution the ultraviolet absorbance specifications. If begins to show a precipitate. Gently swirl the corrected absorbance per centimeter the funnel when precipitation first occurs on path length exceeds the limits prescribed in the inside surface of the funnel to accelerate this paragraph (b), proceed as follows: this process. Carefully draw off the lower Quantitatively transfer the isooctane solu- layer, filter it slowly through a thin layer of tion to a 125–milliliter flask equipped with glass wool fitted loosely in a filter funnel 24/40 joint and evaporate the isooctane on into the first 250–milliliter separatory fun- the steam bath under a stream of nitrogen to nel, and wash in tandem with the 30–milli- a volume of 1 milliliter of hexadecane. Add liter portions of isooctane contained in the 10 milliliters of methyl alcohol and approxi- 250–milliliter separatory funnels. Shaking mately 0.3 gram of sodium borohydride. time for each wash is 1 minute. Repeat the (Minimize exposure of the borohydride to the extraction operation with two additional atmosphere. A measuring dipper may be portions of the sulfoxide-acid mixture, re- used.) Immediately fit a water-cooled con- placing the funnel in the jacket after each denser equipped with a 24/40 joint and with a extraction to keep the wax in solution and drying tube into the flask, mix until the washing each extractive in tandem through borohydride is dissolved, and allow to stand the same three portions of isooctane. for 30 minutes at room temperature, with Collect the successive extractives (300 mil- intermittent swirling. At the end of this pe- liliters total) in a separatory funnel (pref- riod, disconnect the flask and evaporate the erably 2–liter), containing 480 milliliters of methyl alcohol on the steam bath under ni- distilled water, mix, and allow to cool for a trogen until the sodium borohydride begins few minutes after the last extractive has to come out of the solution. Then add 10 mil- been added. Add 80 milliliters of isooctane to liliters of isooctane and evaporate to a vol- the solution and extract by shaking the fun- ume of about 2–3 milliliters. Again, add 10 nel vigorously for 2 minutes. Draw off the milliliters of isooctane and concentrate to a 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

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pressure just before the last of the isooctane to volume in isooctane in a 25–milliliter vol- reaches the level of the adsorbent. (CAUTION: umetric flask. Record the absorbance again. Do not allow the liquid level to recede below If the corrected absorbance does not exceed the adsorbent level at any time.) Remove the the limits prescribed in this paragraph (b), reservoir and decant the 5–milliliter iso- the wax meets the ultraviolet absorbance octane concentrate solution onto the column specifications. and with slight pressure again allow the liquid level to recede to barely above the ad- (c) Petroleum wax may contain one sorbent level. Rapidly complete the transfer or more of the following adjuvants in similarly with two 5–milliliter portions of amounts not greater than that re- isooctane, swirling the flask repeatedly each quired to produce their intended effect: time to assure adequate washing of the res- (1) Antioxidants permitted in food by idue. Just before the final 5–milliliter wash regulations issued in accordance with reaches the top of the adsorbent, add 100 milliliters of isooctane to the reservoir and con- section 409 of the act. tinue the percolation at the 2–3 milliliter per (2) Poly(alkylacrylate) (CAS Reg. No. minute rate. Just before the last of the iso- 27029–57–8), made from long chain (C16- octane reaches the adsorbent level, add 100 C22) alcohols and acrylic acid, or milliliters of 10 percent benzene in isooctane poly(alkylmethacrylate) (CAS Reg. No. to the reservoir and continue the percolation 179529–36–3), made from long chain (C18- at the aforementioned rate. Just before the C ) methacrylate esters, having: solvent mixture reaches adsorbent level, add 22 25 milliliters of 20 percent benzene in iso- (i) A number average molecular octane to the reservoir and continue the per- weight between 40,000 and 100,000; colation at 2–3 milliliters per minute until (ii) A weight average molecular all this solvent mixture has been removed weight (MWw) to number average mo- from the column. Discard all the elution sol- lecular weight (MWn) ratio (MWw/MWn) vents collected up to this point. Add 300 mil- of not less than 3; and liliters of the acetone-benzene-water mixture to the reservoir and percolate through the (iii) Unreacted alkylacrylate or column to elute the polynuclear compounds. alkylmethacrylate monomer content Collect the eluate in a clean 1–liter sepa- not in excess of 14 percent, as deter- ratory funnel. Allow the column to drain mined by a method entitled ‘‘Method 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 small amounts of sodium chloride facilitates omer Content of Poly(alkylacrylate) 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 Premarket Approval (HFS–200), Center Erlenmeyer flask (or optionally into the evaporation flask). Wash the separatory fun- for Food Safety and Applied Nutrition, nel with two additional 20–milliliter portions Food and Drug Administration, 5100 of benzene which are also filtered through Paint Branch Pkwy., College Park, MD the sodium sulfate. Add 1 milliliter of n- 20740, or may be examined at the Cen- hexadecane and completely remove the ben- ter for Food Safety and Applied Nutri- zene by evaporation under nitrogen, using tion’s Library, Food and Drug Admin- the special procedure to eliminate benzene istration, 5100 Paint Branch Pkwy., as previously described under ‘‘Organic Sol- College Park, MD 20740 or at the Na- vents.’’ Quantitatively transfer the residue with isooctane to a 25–milliliter volumetric tional Archives and Records Adminis- flask and adjust to volume. Determine the tration (NARA). For information on absorbance of the solution in the 5–centi- the availability of this material at meter path length cells compared to iso- NARA, call 202–741–6030, or go to: http:// octane 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 peaks in the 250 mμ–260 mμ region, evaporate million of poly(alkylacrylate) or the solution to remove benzene by the proce- poly(alkylmethacrylate) residues as dure under ‘‘Organic Solvents.’’ Dissolve the determined by a method entitled residue, transfer quantitatively, and adjust ‘‘Method for Determining Residual

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Level of Poly(alkylacrylate) in Petro- Use Limitations leum Wax,’’ which is incorporated by On cheese and raw fruits and In an amount not to exceed reference. Copies are available from vegetables as a protective good manufacturing prac- the addresses cited in this paragraph. coating. tice. (d) Petroleum wax is used or intended As a defoamer in food ...... In accordance with § 173.340 for use as follows: of this chapter.

Use Limitations [42 FR 14491, Mar. 15, 1977, as amended at 59 In chewing gum base, as a mas- In an amount not to ex- FR 10986, Mar. 9, 1994] ticatory substance. ceed good manufacturing practice. § 172.890 Rice bran wax. On cheese and raw fruits and Do. vegetables as a protective coat- Rice bran wax may be safely used in ing. food in accordance with the following As a defoamer in food ...... In accordance with conditions: § 173.340 of this chap- (a) It is the refined wax obtained ter. As a component of microcapsules In accordance with from rice bran and meets the following for spice-flavoring substances. § 172.230 of this chap- specifications: ter. Melting point 75 °C to 80 °C. Free fatty acids, maximum 10 percent. [42 FR 14491, Mar. 15, 1977, as amended at 45 Iodine number, maximum 20. FR 48123, July 18, 1980; 47 FR 11838, Mar. 19, Saponification number 75 to 120. 1982; 50 FR 32561, Aug. 13, 1985; 51 FR 19544, May 30, 1986; 54 FR 24897, June 12, 1989; 64 FR (b) It is used or intended for use as 44122, Aug. 13, 1999] follows:

§ 172.888 Synthetic petroleum wax. Food Limitation in food Use

Synthetic petroleum wax may be Candy ...... 50 p.p.m ...... Coating. safely used in or on foods in accordance Fresh fruits and fresh ...... do ...... Do. with the following conditions: vegetables. Chewing gum ...... 21⁄2 pct ...... Plasticizing (a) Synthetic petroleum wax is a material. mixture of solid hydrocarbons, paraffinic in nature, prepared by either catalytic polymerization of ethylene or § 172.892 Food starch-modified. copolymerization of ethylene with lin- Food starch-modified as described in ear (C3 to C12) alpha-olefins, and refined this section may be safely used in food. to meet the specifications prescribed in The quantity of any substance em- this section. ployed to effect such modification shall (b) Synthetic petroleum wax meets not exceed the amount reasonably re- the ultraviolet absorbance limits of quired to accomplish the intended § 172.886(b) when subjected to the ana- physical or technical effect, nor exceed lytical procedure described therein. any limitation prescribed. To insure (c) Synthetic petroleum wax has a safe use of the food starch-modified, number average molecular weight of the label of the food additive container not less than 500 nor greater than 1,200 shall bear the name of the additive as determined by vapor pressure os- ‘‘food starch-modified’’ in addition to mometry. other information required by the Act. (d) Synthetic petroleum wax may Food starch may be modified by treat- contain any antioxidant permitted in ment prescribed as follows: food by regulations issued in accord- (a) Food starch may be acid-modified ance with section 409 of the act, in an by treatment with hydrochloric acid or amount not greater than that required sulfuric acid or both. to produce its intended effect. (b) Food starch may be bleached by (e) Synthetic petroleum wax is used treatment with one or more of the fol- or intended for use as follows: lowing:

Use Limitations Limitations

In chewing gum base, as a In accordance with § 172.615 Active oxygen obtained from hy- masticatory substance. in an amount not to exceed drogen peroxide and/or per- good manufacturing prac- acetic acid, not to exceed 0.45 tice. percent of active oxygen.

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Limitations Limitations

Ammonium persulfate, not to ex- Vinyl acetate ...... Acetyl groups in food ceed 0.075 percent and sulfur starch-modified not to dioxide, not to exceed 0.05 per- exceed 2.5 percent. cent. Chlorine, as calcium hypochlorite, The finished food starch- (e) Food starch may be etherified by not to exceed 0.036 percent of modified is limited to dry starch. use only as a compo- treatment with one of the following: nent of batter for com- mercially processed Limitations foods. Chlorine, as sodium hypochlorite, Acrolein, not to exceed 0.6 per- not to exceed 0.0082 pound of cent. chlorine per pound of dry starch. Epichlorohydrin, not to exceed Potassium permanganate, not to Residual manganese 0.3 percent. exceed 0.2 percent. (calculated as Mn), not Epichlorohydrin, not to exceed Residual propylene to exceed 50 parts per 0.1 percent, and propylene chlorohydrin not more million in food starch- oxide, not to exceed 10 per- than 5 parts per million modified. cent, added in combination or in food starch-modified. Sodium chlorite, not to exceed 0.5 in any sequence. percent. Epichlorohydrin, not to exceed Do. 0.1 percent, followed by propylene oxide, not to exceed 25 (c) Food starch may be oxidized by percent. treatment with chlorine, as sodium hy- Propylene oxide, not to exceed Do. pochlorite, not to exceed 0.055 pound of 25 percent. chlorine per pound of dry starch. (d) Food starch may be esterified by (f) Food starch may be esterified and treatment with one of the following: etherified by treatment with one of the following: Limitations Limitations Acetic anhydride ...... Acetyl groups in food starch-modified not to Acrolein, not to exceed 0.6 per- Acetyl groups in food exceed 2.5 percent. cent and vinyl acetate, not to starch-modified not to Adipic anhydride, not to exceed Do. exceed 7.5 percent. exceed 2.5 percent. 0.12 percent, and acetic anhy- Epichlorohydrin, not to exceed 0.3 Acetyl groups in food dride. percent, and acetic anhydride. starch-modified not to Monosodium orthophosphate ...... Residual phosphate in exceed 2.5 percent. food starch-modified Epichlorohydrin, not to exceed 0.3 not to exceed 0.4 per- percent, and succinic anhy- cent calculated as dride, not to exceed 4 percent. phosphorus. Phosphorus oxychloride, not to Residual propylene 1–Octenyl succinic anhydride, not exceed 0.1 percent, and pro- chlorohydrin not more to exceed 3 percent. pylene oxide, not to exceed 10 than 5 parts per million 1–Octenyl succinic anhydride, not percent. in food starch-modi- to exceed 2 percent, and alu- fied. minum sulfate, not to exceed 2 percent. (g) Food starch may be modified by 1-Octenyl succinic anhydride, not Limited to use as a sta- treatment with one of the following: to exceed 3 percent, followed bilizer or emulsifier in by treatment with a beta-amy- beverages and bev- Limitations lase enzyme that is either an erage bases as de- approved food additive of is fined in § 170.3(n)(3) of Chlorine, as sodium hypochlorite, Residual propylene generally recognized as safe. this chapter. not to exceed 0.055 pound of chlorohydrin not more Phosphorus oxychloride, not to chlorine per pound of dry than 5 parts per million exceed 0.1 percent. starch; 0.45 percent of active in food starch-modi- Phosphorus oxychloride, not to Acetyl groups in food oxygen obtained from hydrogen fied. exceed 0.1 percent, followed by starch-modified not to peroxide; and propylene oxide, either acetic anhydride, not to exceed 2.5 percent. not to exceed 25 percent. exceed 8 percent, or vinyl ace- Sodium hydroxide, not to exceed tate, not to exceed 7.5 percent. 1 percent. Sodium trimetaphosphate ...... Residual phosphate in food starch-modified not to exceed 0.04 (h) Food starch may be modified by a percent, calculated as combination of the treatments pre- phosphorus. scribed by paragraphs (a), (b), and/or (i) Sodium tripolyphosphate and so- Residual phosphate in dium trimetaphosphate. food starch-modified of this section and any one of the not to exceed 0.4 per- treatments prescribed by paragraph (c), cent calculated as (d), (e), (f), or (g) of this section, sub- phosphorus. Succinic anhydride, not to exceed ject to any limitations prescribed by 4 percent. the paragraphs named.

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(i) Food starch may be modified by mation required by the act, the name treatment with the following enzymes: of the additive as follows: (1) The additive identified in para- Enzyme Limitations graph (a)(1) of this section as ‘‘par- Alpha-amylase (E.C. 3.2.1.1) ...... The enzyme must be tially defatted, cooked cottonseed generally recognized flour’’. as safe or approved as (2) The additive identified in para- a food additive for this purpose. The resulting graph (a)(2) of this section as ‘‘defatted nonsweet nutritive sac- cottonseed flour’’. charide polymer has a (3) The additive identified in para- dextrose equivalent of less than 20. graph (a)(3) of this section as ‘‘roasted Beta-amylase (E.C. 3.2.1.2). glandless cottonseed kernels’’. Glucoamylase (E.C. 3.2.1.3). (4) The additive identified in para- Isoamylase (E.C. 3.2.1.68). graph (a)(4) of this section as ‘‘raw Pullulanase (E.C. 3.2.1.41). glandless cottonseed kernels for use in cooked hard candy’’. [42 FR 14491, Mar. 15, 1977, as amended at 43 (d) The Food and Drug Administra- FR 11697, Mar. 21, 1978; 46 FR 32015, June 19, 1981; 57 FR 54700, Nov. 20, 1992; 58 FR 21100, tion and the Environmental Protection Apr. 19, 1993; 66 FR 17509, Apr. 2, 2001] Agency have determined that glandless cottonseed kernels permitted for use § 172.894 Modified cottonseed products by this section are a distinct com- intended for human consumption. modity from glanded cottonseed. The food additive modified cottonseed products may be used for human § 172.896 Dried yeasts. consumption in accordance with the Dried yeast (Saccharomyces cerevisiae following prescribed conditions: and Saccharomyces fragilis) and dried (a) The additive is derived from: torula yeast (Candida utilis) may be (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.

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(3) Negative for Salmonella, E. coli, 173.45 Polymaleic acid and its sodium salt. coagulase positive Staphylococci, Clos- 173.50 Polyvinylpolypyrrolidone. tridium perfringens, Clostridium botu- 173.55 Polyvinylpyrrolidone. linum, or any other recognized micro- 173.60 Dimethylamine-epichlorohydrin copolymer. bial pathogen or any harmful microbial 173.65 Divinylbenzene copolymer. toxin. 173.70 Chloromethylated aminated styrene- (d) The additive is used or intended divinylbenzene resin. for use in the following foods when 173.73 Sodium polyacrylate. standards of identity established under 173.75 Sorbitan monooleate. section 401 of the Act do not preclude such use: Subpart B—Enzyme Preparations and Microorganisms Use Limitations 173.110 Amyloglucosidase derived from (1) In salad dressings as an emul- Not to exceed a con- Rhizopus niveus. sifier and emulsifier salt as de- centration of 5 percent 173.115 Alpha-acetolactate decarboxylase (a- fined in § 170.3(o)(8) of this of the finished salad ALDC) enzyme preparation derived from chapter, stabilizer and thickener dressing. a recombinant Bacillus subtilis. as defined in § 170.3(o)(28) of this chapter, or texturizer as de- 173.120 Carbohydrase and cellulase derived fined in § 170.3(o)(32) of this from Aspergillus niger. chapter. 173.130 Carbohydrase derived from Rhizopus (2) In frozen dessert analogs as a In an amount not to ex- oryzae. stabilizer and thickener as de- ceed good manufac- 173.135 Catalase derived from Microccocus fined in § 170.3(o)(28) of this turing practice. lysodeikticus. chapter, or texturizer as defined 173.140 Esterase-lipase derived from Mucor in § 170.3(o)(32) of this chapter. (3) In sour cream analogs as a Do. miehei. stabilizer and thickener as de- 173.145 Alpha-Galactosidase derived from fined in § 170.3(o)(28) of this Mortierella vinaceae var. raffinoseutilizer. chapter, or texturizer as defined 173.150 Milk-clotting enzymes, microbial. in § 170.3(o)(32) of this chapter. 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 -phosphotrans- chapter, or texturizer as defined ferase 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 Agents and Related Substances stabilizer and thickener as defined in § 170.3(o)(28) of this 173.210 Acetone. chapter, or texturizer as defined 173.220 1,3–Butylene glycol. in § 170.3(o)(32) of this chapter. 173.228 Ethyl acetate. 173.230 Ethylene dichloride. (e) The label and labeling of the in- 173.240 Isopropyl alcohol. gredient shall bear adequate directions 173.250 Methyl alcohol residues. to assure that use of the ingredient 173.255 Methylene chloride. complies with this regulation. 173.270 Hexane. 173.275 Hydrogenated sperm oil. [42 FR 14491, Mar. 15, 1977, as amended at 45 173.280 Solvent extraction process for citric FR 58836, Sept. 5, 1980] acid. 173.290 Trichloroethylene. PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN Subpart D—Specific Usage Additives FOOD FOR HUMAN CONSUMP- 173.300 Chlorine dioxide. TION 173.310 Boiler water additives. 173.315 Chemicals used in washing or to as- Subpart A—Polymer Substances and sist in the peeling of fruits and vegeta- Polymer Adjuvants for Food Treatment bles. 173.320 Chemicals for controlling micro- Sec. organisms in cane-sugar and beet-sugar 173.5 Acrylate-acrylamide resins. mills. 173.10 Modified polyacrylamide resin. 173.322 Chemicals used in delinting cotton- 173.20 Ion-exchange membranes. seed. 173.21 Perfluorinated ion exchange mem- 173.325 Acidified sodium chlorite solutions. branes. 173.340 Defoaming agents. 173.25 Ion-exchange resins. 173.342 Chlorofluorocarbon 113 and 173.40 Molecular sieve resins. perfluorohexane.

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