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§ 182.8890 21 CFR Ch. I (4–1–11 Edition)

used in accordance with good manufac- PART 184—DIRECT FOOD SUB- turing practice. STANCES AFFIRMED AS GEN- § 182.8890 Tocopherols. ERALLY RECOGNIZED AS SAFE (a) Product. Tocopherols. Subpart A—General Provisions (b) Conditions of use. This substance Sec. is generally recognized as safe when 184.1 Substances added directly to human used in accordance with good manufac- food affirmed as generally recognized as turing practice. safe (GRAS).

§ 182.8892 ù-Tocopherol acetate. Subpart B—Listing of Specific Substances Affirmed as GRAS (a) Product. a-Tocopherol acetate. (b) Conditions of use. This substance 184.1005 Acetic acid. is generally recognized as safe when 184.1007 Aconitic acid. used in accordance with good manufac- 184.1009 Adipic acid. 184.1011 Alginic acid. turing practice. 184.1012 a-Amylase enzyme preparation from Bacillus stearothermophilus. § 182.8985 Zinc chloride. 184.1021 Benzoic acid. (a) Product. Zinc chloride. 184.1024 Bromelain. (b) Conditions of use. This substance 184.1025 Caprylic acid. 184.1027 Mixed carbohydrase and protease is generally recognized as safe when enzyme product. used in accordance with good manufac- 184.1033 Citric acid. turing practice. 184.1034 Catalase (bovine liver). 184.1061 Lactic acid. § 182.8988 Zinc gluconate. 184.1063 Enzyme-modified lecithin. 184.1065 Linoleic acid. (a) Product. Zinc gluconate. 184.1069 Malic acid. (b) Conditions of use. This substance 184.1077 Potassium acid tartrate. is generally recognized as safe when 184.1081 Propionic acid. used in accordance with good manufac- 184.1090 Stearic acid. 184.1091 Succinic acid. turing practice. 184.1095 Sulfuric acid. 184.1097 Tannic acid. § 182.8991 Zinc oxide. 184.1099 Tartaric acid. (a) Product. Zinc oxide. 184.1101 Diacetyl tartaric acid esters of mono- and diglycerides. (b) Conditions of use. This substance 184.1115 Agar-agar. is generally recognized as safe when 184.1120 Brown algae. used in accordance with good manufac- 184.1121 Red algae. turing practice. 184.1133 Ammonium alginate. 184.1135 Ammonium bicarbonate. § 182.8994 Zinc stearate. 184.1137 Ammonium carbonate. 184.1138 Ammonium chloride. (a) Product. Zinc stearate prepared 184.1139 Ammonium hydroxide. from stearic acid free from chickedema 184.1140 Ammonium citrate, dibasic. factor. 184.1141a Ammonium phosphate, monobasic. (b) Conditions of use. This substance 184.1141b Ammonium phosphate, dibasic. 184.1143 Ammonium sulfate. is generally recognized as safe when 184.1148 Bacterially-derived carbohydrase used in accordance with good manufac- enzyme preparation. turing practice. 184.1150 Bacterially-derived protease enzyme preparation. § 182.8997 Zinc sulfate. 184.1155 Bentonite. 184.1157 Benzoyl peroxide. (a) Product. Zinc sulfate. 184.1165 n-Butane and iso-butane. (b) Conditions of use. This substance 184.1185 Calcium acetate. is generally recognized as safe when 184.1187 Calcium alginate. used in accordance with good manufac- 184.1191 Calcium carbonate. turing practice. 184.1193 Calcium chloride. 184.1195 Calcium citrate. 184.1199 Calcium gluconate. 184.1201 Calcium glycerophosphate.

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184.1205 Calcium hydroxide. 184.1408 Licorice and licorice derivatives. 184.1206 Calcium iodate. 184.1409 Ground limestone. 184.1207 Calcium lactate. 184.1415 Animal lipase. 184.1210 Calcium oxide. 184.1420 Lipase enzyme preparation derived 184.1212 Calcium pantothenate. from Rhizopus niveus. 184.1221 Calcium propionate. 184.1425 Magnesium carbonate. 184.1229 Calcium stearate. 184.1426 Magnesium chloride. 184.1230 Calcium sulfate. 184.1428 Magnesium hydroxide. 184.1240 Carbon dioxide. 184.1431 Magnesium oxide. 184.1245 Beta-carotene. 184.1434 Magnesium phosphate. 184.1250 Cellulase enzyme preparation de- 184.1440 Magnesium stearate. rived from Trichoderma longibrachi- 184.1443 Magnesium sulfate. atum. 184.1443a Malt. 184.1257 Clove and its derivatives. 184.1444 Maltodextrin. 184.1259 Cocoa butter substitute. 184.1445 Malt syrup (malt extract). 184.1260 Copper gluconate. 184.1446 Manganese chloride. 184.1261 Copper sulfate. 184.1449 Manganese citrate. 184.1262 Corn silk and corn silk extract. 184.1452 Manganese gluconate. 184.1265 Cuprous iodide. 184.1461 Manganese sulfate. 184.1271 L-Cysteine. 184.1472 Menhaden oil. 184.1272 L-Cysteine monohydrochloride. 184.1490 Methylparaben. 184.1277 Dextrin. 184.1498 Microparticulated protein product. 184.1278 Diacetyl. 184.1505 Mono- and diglycerides. 184.1282 Dill and its derivatives. 184.1521 Monosodium phosphate derivatives 184.1287 Enzyme-modified fats. of mono- and diglycerides. 184.1293 Ethyl alcohol. 184.1530 Niacin. 184.1295 Ethyl formate. 184.1535 Niacinamide. 184.1296 Ferric ammonium citrate. 184.1537 Nickel. 184.1297 Ferric chloride. 184.1538 Nisin preparation. 184.1298 Ferric citrate. 184.1540 Nitrogen. 184.1301 Ferric phosphate. 184.1545 Nitrous oxide. 184.1304 Ferric pyrophosphate. 184.1553 Peptones. 184.1307 Ferric sulfate. 184.1555 Rapeseed oil. 184.1307a Ferrous ascorbate. 184.1560 Ox bile extract. 184.1307b Ferrous carbonate. 184.1563 Ozone. 184.1307c Ferrous citrate. 184.1583 Pancreatin. 184.1307d Ferrous fumarate. 184.1585 Papain. 184.1308 Ferrous gluconate. 184.1588 Pectins. 184.1311 Ferrous lactate. 184.1595 Pepsin. 184.1315 Ferrous sulfate. 184.1610 Potassium alginate. 184.1316 Ficin. 184.1613 Potassium bicarbonate. 184.1317 Garlic and its derivatives. 184.1619 Potassium carbonate. 184.1318 Glucono delta-lactone. 184.1622 Potassium chloride. 184.1321 Corn gluten. 184.1625 Potassium citrate. 184.1322 Wheat gluten. 184.1631 Potassium hydroxide. 184.1323 Glyceryl monooleate. 184.1634 Potassium iodide. 184.1324 Glyceryl monostearate. 184.1635 Potassium iodate. 184.1328 Glyceryl behenate. 184.1639 Potassium lactate. 184.1329 Glyceryl palmitostearate. 184.1643 Potassium sulfate. 184.1330 Acacia (gum arabic). 184.1655 Propane. 184.1333 Gum ghatti. 184.1660 Propyl gallate. 184.1339 Guar gum. 184.1666 Propylene glycol. 184.1343 Locust (carob) bean gum. 184.1670 Propylparaben. 184.1349 Karaya gum (sterculia gum). 184.1676 Pyridoxine hydrochloride. 184.1351 Gum tragacanth. 184.1685 Rennet (animal-derived) and 184.1355 Helium. chymosin preparation (fermentation-de- 184.1366 Hydrogen peroxide. rived). 184.1370 Inositol. 184.1695 Riboflavin. 184.1372 Insoluble glucose isomerase enzyme 184.1697 Riboflavin-5′-phosphate (sodium). preparations. 184.1698 Rue. 184.1375 Iron, elemental. 184.1699 Oil of rue. 184.1386 Isopropyl citrate. 184.1702 Sheanut oil. 184.1387 Lactase enzyme preparation from 184.1721 Sodium acetate. Candida pseudotropicalis. 184.1724 Sodium alginate. 184.1388 Lactase enzyme preparation from 184.1733 Sodium benzoate. Kluyveromyces lactis. 184.1736 Sodium bicarbonate. 184.1400 Lecithin. 184.1742 Sodium carbonate.

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184.1751 Sodium citrate. poses and under the conditions pre- 184.1754 Sodium diacetate. scribed. The regulations in this part 184.1763 Sodium hydroxide. shall sufficiently describe each ingre- 184.1764 Sodium hypophosphite. 184.1768 Sodium lactate. dient to identify the characteristics of 184.1769a Sodium metasilicate. the ingredient that has been affirmed 184.1784 Sodium propionate. as GRAS and to differentiate it from 184.1792 Sodium sesquicarbonate. other possible versions of the ingre- 184.1801 Sodium tartrate. dient that have not been affirmed as 184.1804 Sodium potassium tartrate. GRAS. Ingredients affirmed as GRAS 184.1807 Sodium thiosulfate. in this part are also GRAS as indirect 184.1835 Sorbitol. 184.1845 Stannous chloride (anhydrous and human food ingredients, subject to any dihydrated). limitations prescribed in parts 174, 175, 184.1848 Starter distillate. 176, 177, 178 or § 179.45 of this chapter or 184.1851 Stearyl citrate in part 186 of this chapter. The purity 184.1854 Sucrose. specifications in this part do not apply 184.1857 Corn sugar. when the ingredient is used in indirect 184.1859 Invert sugar. applications. However, when used in in- 184.1865 Corn syrup. direct applications, the ingredient 184.1866 High fructose corn syrup. 184.1875 Thiamine hydrochloride. must be of a purity suitable for its in- 184.1878 Thiamine mononitrate. tended use in accordance with 184.1890 a-Tocopherols. § 170.30(h)(1) of this chapter. 184.1901 Triacetin. (b) Any ingredient affirmed as GRAS 184.1903 Tributyrin. in this part shall be used in accordance 184.1911 Triethyl citrate. with current good manufacturing prac- 184.1914 Trypsin. tice. For the purpose of this part, cur- 184.1923 Urea. 184.1924 Urease enzyme preparation from rent good manufacturing practice in- Lactobacillus fermentum. cludes the requirements that a direct 184.1930 Vitamin A. human food ingredient be of appro- 184.1945 Vitamin B12. priate food grade; that it be prepared 184.1950 Vitamin D. and handled as a food ingredient; and 184.1973 Beeswax (yellow and white). that the quantity of the ingredient 184.1976 Candelilla wax. added to food does not exceed the 184.1978 Carnauba wax. 184.1979 Whey. amount reasonably required to accom- 184.1979a Reduced lactose whey. plish the intended physical, nutri- 184.1979b Reduced minerals whey. tional, or other technical effect in 184.1979c Whey protein concentrate. food. 184.1983 Bakers yeast extract. (1) If the ingredient is affirmed as 184.1984 Zein. GRAS with no limitations on its condi- 184.1985 Aminopeptidase enzyme preparations of use other than current good tion derived from lactococcus lactis. manufacturing practice, it shall be re- AUTHORITY: 21 U.S.C. 321, 342, 348, 371. garded as GRAS if its conditions of use SOURCE: 42 FR 14653, Mar 15, 1977, unless are consistent with the requirements of otherwise noted. paragraph (b), (c), and (d) of this section. When the Food and Drug Admin- EDITORIAL NOTE: Nomenclature changes to part 184 appear at 66 FR 56035, Nov. 6, 2001, 66 istration (FDA) determines that it is FR 66742, Dec. 27, 2001, 68 FR 15355, Mar. 31, appropriate, the agency will describe 2003, 69 FR 13717, Mar. 24, 2004, 70 FR 40880, one or more current good manufac- July 15, 2005, and 70 FR 67651, Nov. 8, 2005. turing practice conditions of use in the regulation that affirms the GRAS sta- Subpart A—General Provisions tus of the ingredient. For example, when the safety of an ingredient has § 184.1 Substances added directly to been evaluated on the basis of limited human food affirmed as generally conditions of use, the agency will de- recognized as safe (GRAS). scribe in the regulation that affirms (a) The direct human food ingredi- the GRAS status of the ingredient, one ents listed in this part have been re- or more of these limited conditions of viewed by the Food and Drug Adminis- use, which may include the category of tration and determined to be generally food(s), the technical effect(s) or func- recognized as safe (GRAS) for the pur- tional use(s) of the ingredient, and the

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level(s) of use. If the ingredient is used promulgated pursuant to this section under conditions that are significantly constitutes a determination that ex- different from those described in the cluded uses would result in adultera- regulation, that use of the ingredient tion of the food in violation of section may not be GRAS. In such a case, a 402 of the Act, and the failure of any manufacturer may not rely on the reg- person to come forward with proof of ulation as authorizing that use but such an applicable prior sanction in re- shall independently establish that that sponse to the proposal will constitute a use is GRAS or shall use the ingredient waiver of the right to assert or rely on in accordance with a food additive reg- such sanction at any later time. The ulation. Persons seeking FDA approval notice will also constitute a proposal of an independent determination that a to establish a regulation under part 181 use of an ingredient is GRAS may sub- of this chapter, incorporating the same mit a GRAS petition in accordance provisions, in the event that such a with § 170.35 of this chapter. regulation is determined to be appro- (2) If the ingredient is affirmed as priate as a result of submission of proof GRAS with specific limitation(s), it of such an applicable prior sanction in shall be used in food only within such response to the proposal. limitation(s), including the category of (f) The label and labeling of the in- food(s), the functional use(s) of the ingredient and any intermediate mix of gredient, and the level(s) of use. Any the ingredient for use in finished food use of such an ingredient not in full shall bear, in addition to the other la- compliance with each such established beling required by the Act: limitation shall require a food additive (1) The name of the ingredient, ex- regulation. cept where exempted from such label- (3) If the ingredient is affirmed as ing in part 101 of this chapter. GRAS for a specific use, without a gen- (2) A statement of concentration of eral evaluation of use of the ingredient, the ingredient in any intermediate other uses may also be GRAS. mix; or other information to permit a (c) The listing of a food ingredient in food processor independently to deter- this part does not authorize the use of mine that use of the ingredients will be such substance in a manner that may in accordance with any limitations and lead to deception of the consumer or to good manufacturing practice gudelines any other violation of the Federal prescribed. Food, Drug, and Cosmetic Act (the (3) Adequate directions for use to Act). provide a final food product that complies with any limitations prescribed (d) The listing of more than one in- for the ingredient(s). gredient to produce the same techno- logical effect does not authorize use of [42 FR 14653, Mar. 15, 1977, as amended at 42 a combination of two or more ingredi- FR 55205, Oct. 14, 1977; 48 FR 48457, 48459, Oct. ents to accomplish the same techno- 19, 1983; 62 FR 15110, Mar. 31, 1997] logical effect in any one food at a combined level greater than the highest Subpart B—Listing of Specific level permitted for one of the ingredi- Substances Affirmed as GRAS ents. (e) If the Commissioner of Food and § 184.1005 Acetic acid.

Drugs is aware of any prior sanction (a) Acetic acid (C2H4O2, CAS Reg. No. for use of an ingredient under condi- 64–19–7) is known as ethanoic acid. It tions different from those proposed to occurs naturally in plant and animal be affirmed as GRAS, he will concur- tissues. It is produced by fermentation rently propose a separate regulation of carbohydrates or by organic syn- covering such use of the ingredient thesis. The principal synthetic meth- under part 181 of this chapter. If the ods currently employed are oxidation Commissioner is unaware of any such of acetaldehyde derived from ethylene, applicable prior sanction, the proposed liquid phase oxidation of butane, and regulation will so state and will re- reaction of carbon monoxide with quire any person who intends to assert methanol derived from natural gas. or rely on such sanction to submit (b) The ingredient meets the speci- proof of its existence. Any regulation fications of the Food Chemicals Codex,

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3d Ed. (1981), p. 8, which is incorporated CAS Reg. No. 000499–12–7) occurs in the by reference. Copies are available from leaves and tubers of Aconitum napellus the National Academy Press, 2101 Con- L. and other Ranunculaceae. stitution Ave. NW., Washington, DC Transaconitic acid can be isolated dur- 20418, or available for inspection at the ing sugarcane processing, by precipita- National Archives and Records Admin- tion as the calcium salt from cane istration (NARA). For information on sugar or molasses. It may be syn- the availability of this material at thesized by sulfuric acid dehydration of NARA, call 202–741–6030, or go to: http:// citric acid, but not by the www.archives.gov/federallregister/ methanesulfonic acid method. codeloflfederallregulations/ (b) The ingredient meets the fol- ibrllocations.html. lowing specifications: (c) The ingredient is used as a curing (1) Assay. Not less than 98.0 percent and pickling agent as defined in of C3H3(COOH)3, using the ‘‘Food § 170.3(o)(5) of this chapter; flavor Chemicals Codex,’’ 4th ed. (1996), pp. enhancer as defined in § 170.3(o)(11) of 102–103, test for citric acid, which is in- this chapter; flavoring agent and adju- corporated by reference in accordance vant as defined in § 170.3(o)(12) of this with 5 U.S.C. 552(a) and 1 CFR part 51, chapter; pH control agent as defined in and a molecular weight of 174.11. Copies § 170.3(o)(23) of this chapter; as a sol- of the material incorporated by ref- vent and vehicle as defined in erence are available from the National § 170.3(o)(27) of this chapter; and as a Academy Press, Box 285, 2101 Constitu- boiler water additive complying with tion Ave. NW., Washington, DC 20055 § 173.310 of this chapter. (Internet address http://www.nap.edu), (d) The ingredient is used in food at or may be examined at the Center for levels not to exceed current good man- Food Safety and Applied Nutrition’s ufacturing practice in accordance with Library, Food and Drug Administra- § 184.1(b)(1). Current good manufac- tion, 5100 Paint Branch Pkwy., College turing practice results in a maximum Park, MD 20740, or at the National Ar- level as served, of 0.25 percent for chives and Records Administration baked goods as defined in § 170.3(n)(1) of (NARA). For information on the avail- this chapter; 0.8 percent for cheeses as ability of this material at NARA, call defined in § 170.3(n)(5) of this chapter 202–741–6030, or go to: http:// and dairy product analogs as defined in www.archives.gov/federallregister/ § 170.3(n)(10) of this chapter; 0.5 percent codeloflfederallregulations/ for chewing gum as defined in ibrllocations.html. § 170.3(n)(6) of this chapter; 9.0 percent (2) Melting point. Not less than 195 °C for condiments and relishes as defined and the determination results in de- in § 170.3(n)(8) of this chapter; 0.5 per- composition of aconitic acid. cent for fats and oils as defined in (3) Heavy metals (as Pb). Not more § 170.3(n)(12) of this chapter; 3.0 percent than 10 parts per million. for gravies and sauces as defined in (4) Arsenic (as As). Not more than 3 § 170.3(n)(24) of this chapter; 0.6 percent parts per million. for meat products as defined in (5) Oxalate. Passes test. § 170.3(n)(29) of this chapter; and 0.15 (6) Readily carbonizable substances. percent or less for all other food cat- Passes the test for citric acid of the egories. The ingredient may also be ‘‘Food Chemicals Codex,’’ 4th ed. (1996), used in boiler water additives at levels pp. 102–103, which is incorporated by not to exceed current good manufac- reference in accordance with 5 U.S.C. turing practice. 552(a) and 1 CFR part 51. The avail- (e) Prior sanctions for this ingredient ability of this incorporation by ref- different from the uses established in erence is given in paragraph (b)(1) of this section do not exist or have been this section. waived. (7) Residue on ignition. Not more than [47 FR 27814, June 25, 1982] 0.1 percent as determined by the ‘‘Food Chemicals Codex,’’ 4th ed. (1996), pp. § 184.1007 Aconitic acid. 102–103, test for citric acid, which is in- (a) Aconitic acid (1,2,3- corporated by reference in accordance propenetricarboxylic acid (C6H6O6), with 5 U.S.C. 552(a) and 1 CFR part 51. 486

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The availability of this incorporation ester. The ester is purified by recrys- by reference is given in paragraph tallization from ethanol. The melting (b)(1) of this section. range of the ester is 153° to 154 °C. (c) The ingredient is used as a fla- (c) The ingredient is used as a flavoring substance and adjuvant as de- voring agent as defined in § 170.3(o)(12) fined in § 170.3(o)(12) of this chapter. of this chapter; leavening agent as de- (d) The ingredient is used in food, in fined in § 170.3(o)(17) of this chapter; accordance with § 184.1(b)(1), at levels and pH control agent as defined in not to exceed good manufacturing § 170.3(o)(23) of this chapter. practice. Current good manufacturing (d) The ingredient is used in foods at practice results in a maximum level, as levels not to exceed current good man- served, of 0.003 percent for baked goods ufacturing practice in accordance with as defined in § 170.3(n)(1) of this chap- § 184.1(b)(1). Current good manufac- ter, 0.002 percent for alcoholic bev- turing practice results in maximum erages as defined in § 170.3(n)(2) of this levels, as served, of 0.05 percent for chapter, 0.0015 percent for frozen dairy baked goods as defined in § 170.3(n)(1) of products as defined in § 170.3(n)(20) of this chapter; 0.005 percent for non- this chapter, 0.0035 percent for soft alcoholic beverages as defined in candy as defined in § 170.3(n)(38) of this § 170.3(n)(3) of this chapter; 5.0 percent chapter, and 0.0005 percent or less for for condiments and relishes as defined all other food categories. in § 170.3(n)(8) of this chapter; 0.45 per- (e) Prior sanctions for this ingredient cent for dairy product analogs as de- different from the uses established in fined in § 170.3(n)(10) of this chapter; 0.3 this section do not exist or have been percent for fats and oil as defined in waived. § 170.3(n)(12) of this chapter; 0.0004 percent for frozen dairy desserts as defined [43 FR 47724, Oct. 17, 1978, as amended at 49 in § 170.3(n)(20) of this chapter; 0.55 per- FR 5610, Feb. 14, 1984; 64 FR 1759, Jan. 12, 1999] cent for gelatin and puddings as defined in § 170.3(n)(22) of this chapter; 0.1 § 184.1009 Adipic acid. percent for gravies as defined in § 170.3(n)(24) of this chapter; 0.3 percent (a) Adipic acid (C6H10O4, CAS Reg. No. 00124–04–9) is also known as 1,4- for meat products as defined in § 170.3(n)(29) of this chapter; 1.3 percent butanedicarboxylic acid or hexane- for snack foods as defined in dioic acid. It is prepared by nitric acid § 170.3(n)(37) of this chapter; and 0.02 oxidation of cyclohexanol or percent or less for all other food cat- cyclohexanone or a mixture of the two. egories. (b) The ingredient meets the speci- (e) Prior sanctions for adipic acid dif- fications of the Food Chemicals Codex, ferent from the uses established in this 3d Ed. (1981), p. 11, which is incor- section do not exist or have been porated by reference (Copies are avail- waived. able from the National Academy Press, 2101 Constitution Ave., NW., Wash- [47 FR 27810, June 25, 1982] ington, DC 20418, or available for inspection at the National Archives and § 184.1011 Alginic acid. Records Administration (NARA). For (a) Alginic acid is a colloidal, hydro- information on the availability of this philic polysaccharide obtained from material at NARA, call 202–741–6030, or certain brown algae by alkaline extrac- go to: http://www.archives.gov/ tion. federallregister/ (b) The ingredient meets the speci- codeloflfederallregulations/ fications of the Food Chemicals Codex, ibrllocations.html.), and the following 3d Ed. (1981), p. 13, which is incor- additional specifications: porated by reference. Copies are avail- (1) The adipic acid is converted to its able from the National Academy Press, corresponding amide. The amide is pu- 2101 Constitution Ave. NW., Wash- rified by recrystallization from water ington, DC 20418, or available for in- or aqueous ethanol. The melting range spection at the National Archives and of the amide is 219° to 220 °C. Records Administration (NARA). For (2) The adipic acid is converted to its information on the availability of this corresponding bis-p-p-bromophenacyl material at NARA, call 202–741–6030, or

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go to: http://www.archives.gov/ codeloflfederallregulations/ federallregister/ ibrllocations.html. codeloflfederallregulations/ (c) In accordance with § 184.1(b)(1), ibrllocations.html. the ingredient is used in food with no (c) In accordance with § 184.1(b)(2), limitation other than current good the ingredient is used in food only manufacturing practices. The affirma- within the following specific limitation of this ingredient as GRAS as a di- tions: rect human food ingredient is based upon the following current good manu- Maximum level of facturing practice conditions of use: Category of food use in food (as Functional use (1) The ingredient is used as an en- served) zyme, as defined in § 170.3(o)(9) of this Soup and soup Not to exceed cur- Emulsifier, emulsi- chapter, in the hydrolysis of edible mixes, rent good manu- fier salt, starch to produce maltodextrins and § 170.3(n) (40) facturing prac- § 170.3(o)(8) of of this chapter. tice. this chapter; for- nutritive carbohydrate sweeteners. mulation aid, (2) The ingredient is used at levels § 170.3(o)(14) of not to exceed current good manufac- this chapter; sta- turing practices. bilizer, thickener, § 170.3(o)(28) of [60 FR 55789, Nov. 3, 1995] this chapter. § 184.1021 Benzoic acid. (d) Prior sanctions for this ingredient (a) Benzoic acid is the chemical different from the use established in benzenecarboxylic acid (C7H6O2), occur- this section do not exist or have been ring in nature in free and combined waived. forms. Among the foods in which ben- [47 FR 47375, Oct. 26, 1982] zoic acid occurs naturally are cran- berries, prunes, plums, cinnamon, ripe § 184.1012 ù-Amylase enzyme prepara- cloves, and most berries. Benzoic acid tion from Bacillus is manufactured by treating molten stearothermophilus. phthalic anhydride with steam in the (a) a-Amylase enzyme preparation is presence of a zinc oxide catalyst, by obtained from the culture filtrate that the hydrolysis of benzotrichloride, or results from a pure culture fermenta- by the oxidation of toluene with nitric tion of a nonpathogenic and acid or sodium bichromate or with air in the presence of a transition metal nontoxicogenic strain of Bacillus salt catalyst. stearothermophilus. Its characterizing (b) The ingredient meets the speci- enzyme activity is a-amylase (1,4 a-D fications of the ‘‘Food Chemicals glucan glucanohydrolase (E.C. 3.2.1.1)). Codex,’’ 3d Ed. (1981), p. 35, which is in- (b) The ingredient meets the general corporated by reference. Copies may be and additional requirements for en- obtained from the National Academy zyme preparations in the ‘‘Food Chemi- Press, 2101 Constitution Ave. NW., cals Codex,’’ 3d ed. (1981), pp. 107–110, Washington, DC 20418, or may be exam- which is incorporated by reference in ined at the National Archives and accordance with 5 U.S.C. 552(a) and 1 Records Administration (NARA). For CFR part 51. Copies are available from information on the availability of this the National Academy Press, 2101 Con- material at NARA, call 202–741–6030, or stitution Ave. NW., Washington, DC go to: http://www.archives.gov/ 20418, or may be examined at the Office federallregister/ of Premarket Approval (HFS–200), Cen- codeloflfederallregulations/ ter for Food Safety and Applied Nutri- ibrllocations.html. tion, Food and Drug Administration, (c) The ingredient is used as an anti- 1110 Vermont Ave. NW., suite 1200, microbial agent as defined in Washington, DC, or at the National Ar- § 170.3(o)(2) of this chapter, and as a fla- chives and Records Administration voring agent and adjuvant as defined in (NARA). For information on the avail- § 170.3(o)(12) of this chapter. ability of this material at NARA, call (d) The ingredient is used in food at 202–741–6030, or go to: http:// levels not to exceed good manufac- www.archives.gov/federallregister/ turing practice. Current usage results

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in a maximum level of 0.1 percent in § 184.1025 Caprylic acid. food. (The Food and Drug Administra- (a) Caprylic acid [CH (CH ) COOH, tion has not determined whether sig- 3 2 6 nificantly different conditions of use CAS Reg. No. 124–07–2] is the chemical would be GRAS). name for octanoic acid. It is considered (e) Prior sanctions for this ingredient to be a short or medium chain fatty different from those uses established in acid. It occurs normally in various this section, or different from that set foods and is commercially prepared by forth in part 181 of this chapter, do not oxidation of n-octanol or by fermenta- exist or have been waived. tion and fractional distillation of the volatile fatty acids present in coconut [42 FR 14653, Mar. 15, 1977, as amended at 49 oil. FR 5610, Feb. 14, 1984] (b) The ingredient meets the speci- § 184.1024 Bromelain. fications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), p. 207, which is in- (a) Bromelain (CAS Reg. No. 9001–00– 7) is an enzyme preparation derived corporated by reference. Copies may be from the pineapples Ananas comosus obtained from the National Academy and A. bracteatus L. It is a white to Press, 2101 Constitution Ave. NW., light tan amorphous powder. Its char- Washington, DC 20418, or may be exam- acterizing enzyme activity is that of a ined at the National Archives and peptide hydrolase (EC 3.4.22.32). Records Administration (NARA). For (b) The ingredient meets the general information on the availability of this requirements and additional require- material at NARA, call 202–741–6030, or ments for enzyme preparations in the go to: http://www.archives.gov/ Food Chemicals Codex, 3d ed. (1981), p. federallregister/ 110, which is incorporated by reference codeloflfederallregulations/ in accordance with 5 U.S.C. 552(a) and 1 ibrllocations.html. CFR part 51. Copies are available from (c) The ingredient is used as a fla- the National Academy Press, 2101 Con- voring agent and adjuvant as defined in stitution Ave. NW., Washington, DC, or § 170.3(o)(12) of this chapter. may be examined at the Office of Pre- (d) The ingredient is used in foods in market Approval (HFS–200), Food and accordance with § 184.1(b)(1), at levels Drug Administration, 5100 Paint not to exceed good manufacturing Branch Pkwy., College Park, MD 20740, practice. Current good manufacturing and at the National Archives and practices result in maximum levels, as Records Administration (NARA). For served, of: 0.013 percent for baked goods information on the availability of this as defined in § 170.3(n)(1) of this chap- material at NARA, call 202–741–6030, or ter; 0.04 percent for cheeses as defined go to: http://www.archives.gov/ in § 170.3(n)(5) of this chapter; 0.005 per- federallregister/ cent for fats and oils as defined in codeloflfederallregulations/ § 170.3(n)(12) of this chapter, for frozen ibrllocations.html. dairy desserts as defined in § 170.3(n)(20) (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no of this chapter, for gelatins and pud- limitation other than current good dings as defined in § 170.3(n)(22) of this manufacturing practice. The affirma- chapter, for meat products as defined tion of this ingredient as GRAS as a di- in § 170.3(n)(29) of this chapter, and for rect food ingredient is based upon the soft candy as defined in § 170.3(n)(38) of following current good manufacturing this chapter; 0.016 percent for snack practice conditions of use: foods as defined in § 170.3(n)(37) of this (1) The ingredient is used as an en- chapter; and 0.001 percent or less for all zyme as defined in § 170.3(o)(9) of this other food categories. chapter to hydrolyze proteins or (e) Prior sanctions for this ingredient polypeptides. different from the uses established in (2) The ingredient is used in food at this section do not exist or have been levels not to exceed current good man- waived. ufacturing practice. [43 FR 19843, May 9, 1978, as amended at 49 [60 FR 32910, June 26, 1995] FR 5611, Feb. 14, 1984]

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§ 184.1027 Mixed carbohydrase and tion using Candida spp., described in protease enzyme product. §§ 173.160 and 173.165 of this chapter; and (a) Mixed carbohydrase and protease by the solvent extraction process de- enzyme product is an enzyme prepara- scribed in § 173.280 of this chapter for tion that includes carbohydrase and the recovery of citric acid from Asper- protease activity. It is obtained from gillus niger fermentation liquor. the culture filtrate resulting from a (b) The ingredient meets the specifications of the Food Chemicals Codex, pure culture fermentation of a non- 3d ed. (1981), pp. 86–87, and its third sup- pathogenic strain of B. licheniformis. plement (March 1992), pp. 107–108, which (b) The ingredient meets the speci- are incorporated by reference in ac- fications of the Food Chemicals Codex, cordance with 5 U.S.C. 552(a) and 1 CFR 3d Ed. (1981), p. 107, which is incor- part 51. Copies are available from the porated by reference. Copies are avail- National Academy Press, 2101 Constitu- able from the National Academy Press, tion Ave. NW., Washington, DC 20418, 2101 Constitution Ave. NW., Wash- and the Center for Food Safety and Ap- ington, DC 20418, or available for in- plied Nutrition (HFS–200), 5100 Paint spection at the National Archives and Branch Pkwy., College Park, MD 20740, Records Administration (NARA). For or may be examined at the National information on the availability of this Archives and Records Administration material at NARA, call 202–741–6030, or (NARA). For information on the avail- go to: http://www.archives.gov/ ability of this material at NARA, call federallregister/ 202–741–6030, or go to: http:// codeloflfederallregulations/ www.archives.gov/federallregister/ ibrllocations.html. codeloflfederallregulations/ (c) In accordance with § 184.1(b)(1), ibrllocations.html. the ingredient is used in food with no (c) In accordance with § 184.1(b)(1), limitation other than current good the ingredient is used in food with no manufacturing practice. The affirma- limitations other than current good tion of this ingredient as generally rec- manufacturing practice. ognized as safe as a direct human food (d) Prior sanctions for this ingredient ingredient is based upon the following different from the uses established in current good manufacturing practice this section do not exist or have been conditions of use: waived. (1) The ingredient is used as an enzyme, as defined in § 170.3(o)(9) of this [59 FR 63895, Dec. 12, 1994] chapter, to hydrolyze proteins or car- § 184.1034 Catalase (bovine liver). bohydrates. (2) The ingredient is used in the fol- (a) Catalase (bovine liver) (CAS Reg. lowing foods at levels not to exceed No. 81457–95–6) is an enzyme prepara- current good manufacturing practice: tion obtained from extracts of bovine alcoholic beverages, as defined in liver. It is a partially purified liquid or § 170.3(n)(2) of this chapter, candy, nu- powder. Its characterizing enzyme ac- tritive sweeteners, and protein tivity is catalase (EC 1.11.1.6). hydrolyzates. (b) The ingredient meets the general requirements and additional require- [48 FR 240, Jan. 4, 1983] ments for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. § 184.1033 Citric acid. 110, which is incorporated by reference (a) Citric acid (C6H8O7, CAS Reg. No. in accordance with 5 U.S.C. 552(a) and 1 77–92–9) is the compound 2-hydroxy- CFR part 51. Copies are available from 1,2,3-propanetricarboxylic acid. It is a the National Academy Press, 2101 Con- naturally occurring constituent of stitution Ave., NW., Washington, DC plant and animal tissues. It occurs as 20418, or may be examined at the Office colorless crystals or a white powder of Premarket Approval (HFS–200), Food and may be anhydrous or contain one and Drug Administration, 5100 Paint mole of water per mole of citric acid. Branch Pkwy., College Park, MD 20740, Citric acid may be produced by recov- and at the National Archives and ery from sources such as lemon or pine- Records Administration (NARA). For apple juice; by mycological fermenta- information on the availability of this

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material at NARA, call 202–741–6030, or the following current good manufac- go to: http://www.archives.gov/ turing practice conditions of use: federallregister/ (1) The ingredient is used as an anti- codeloflfederallregulations/ microbial agent as defined in ibrllocations.html. § 170.3(o)(2) of this chapter; a curing and (c) In accordance with § 184.1(b)(1), pickling agent as defined in § 170.3(o)(5) the ingredient is used in food with no of this chapter; a flavor enhancer as de- limitation other than current good fined in § 170.3(o)(11) of this chapter; a manufacturing practice. The affirma- flavoring agent and adjuvant as defined tion of this ingredient as GRAS as a di- in § 170.3(o)(12) of this chapter; a pH rect food ingredient is based upon the control agent as defined in § 170.3(o)(23) following current good manufacturing of this chapter; and a solvent and vehi- practice conditions of use: cle as defined in § 170.3(o)(27) of this (1) The ingredient is used as an en- chapter. zyme as defined in § 170.3(o)(9) of this (2) The ingredient is used in food, ex- chapter to decompose hydrogen per- cept in infant foods and infant for- oxide. mulas, at levels not to exceed current (2) The ingredient is used in food at good manufacturing practice. levels not to exceed current good man- (d) Prior sanctions for this ingredient ufacturing practice. different from the uses established in [60 FR 32910, June 26, 1995, as amended at 69 this section do not exist or have been FR 24512, May 4, 2004] waived.

§ 184.1061 Lactic acid. [49 FR 35367, Sept. 7, 1984]

(a) Lactic acid (C3H6O3, CAS Reg. § 184.1063 Enzyme-modified lecithin. Nos.: DL mixture, 598–82–3; L-isomer, 79– (a) Enzyme-modified lecithin is pre- 33–4; D-isomer, 10326–41–7), the chemical 2-hydroxypropanoic acid, occurs natu- pared by treating lecithin with either rally in several foods. It is produced phospholipase A2 (EC 3.1.1.4) or pan- commercially either by fermentation creatin. of carbohydrates such as glucose, su- (b) The ingredient meets the speci- crose, or lactose, or by a procedure in- fications in paragraphs (b)(1) through volving formation of lactonitrile from (b)(8) of this section. Unless otherwise acetaldehyde and hydrogen cyanide noted, compliance with the specifica- and subsequent hydrolysis to lactic tions listed below is determined ac- acid. cording to the methods set forth for (b) The ingredient meets the speci- lecithin in the Food Chemicals Codex, fications of the Food Chemicals Codex, 4th ed. (1996), pp. 220–221, which are in- 3d Ed. (1981), p. 159, which is incor- corporated by reference in accordance porated by reference. Copies are avail- with 5 U.S.C. 552(a) and 1 CFR part 51. able from the National Academy Press, Copies are available from the National 2101 Constitution Avenue, NW., Wash- Academy Press, 2101 Constitution Ave. ington, DC 20418, or available for in- NW., Washington DC 20418, or may be spection at the National Archives and examined at the Center for Food Safety Records Administration (NARA). For and Applied Nutrition’s Library, 5100 information on the availability of this Paint Branch Pkwy., College Park, MD material at NARA, call 202–741–6030, or 20740, or at the National Archives and go to: http://www.archives.gov/ Records Administration (NARA). For federallregister/ information on the availability of this codeloflfederallregulations/ material at NARA, call 202–741–6030, or ibrllocations.html. go to: http://www.archives.gov/ (c) In accordance with § 184.1(b)(1), federallregister/ the ingredient is used in food with no codeloflfederallregulations/ limitation other than current good ibrllocations.html. manufacturing practice. The affirma- (1) Acetone-insoluble matter tion of this ingredient as generally rec- (phosphatides), not less than 50.0 per- ognized as safe (GRAS) as a direct cent. human food ingredient is based upon (2) Acid value, not more than 40.

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(3) Lead, not more than 1.0 part per method, low pressure splitting with million, as determined by atomic ab- catalyst, continuous high pressure sorption spectroscopy. counter current splitting, and medium (4) Heavy metals (as Pb), not more pressure autoclave splitting with cata- than 20 parts per million. lyst. (5) Hexane-insoluble matter, not (b) The ingredient must be of a pu- more than 0.3 percent. rity suitable for its intended use. The (6) Peroxide value, not more than 20. ingredient must also meet the speci- (7) Water, not more than 4.0 percent. fications in § 172.860(b) of this chapter. (8) Lysolecithin, 50 to 80 mole percent (c) In accordance with § 184.1(b)(1), of total phosphatides as determined by the ingredient is used in food with no ‘‘Determination of Lysolecithin Con- limitation other than current good tent of Enzyme-Modified Lecithin: manufacturing practice. The affirma- Method I,’’ dated 1985, which is incor- tion of this ingredient as generally rec- porated by reference in accordance ognized as safe (GRAS) as a direct with 5 U.S.C. 552(a) and 1 CFR part 51. human food ingredient is based upon Copies are available from the Division the following current good manufac- of Petition Control, Center for Food turing practice conditions of use: Safety and Applied Nutrition (HFS– (1) The ingredient is used as a fla- 215), Food and Drug Administration, voring agent and adjuvant as defined in 5100 Paint Branch Pkwy., College Park, § 170.3(o)(12) of this chapter and as a nu- MD 20740, or may be examined at the trient supplement as defined in Center for Food Safety and Applied Nu- § 170.3(o)(20) of this chapter. trition’s Library, 5100 Paint Branch (2) The ingredient is used in foods at Pkwy., College Park, MD 20740, or at levels not to exceed current good man- the National Archives and Records Ad- ufacturing practice. The ingredient ministration (NARA). For information may be used in infant formula in ac- on the availability of this material at cordance with section 412(g) of the Fed- NARA, call 202–741–6030, or go to: http:// eral Food, Drug, and Cosmetic Act (the www.archives.gov/federallregister/ act) or with regulations promulgated codeloflfederallregulations/ under section 412(a)(2) of the act. ibrllocations.html. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the uses established in the ingredient is used in food with no this section do not exist or have been limitation other than current good waived. manufacturing practice. The affirma- [49 FR 48534, Dec. 13, 1984, as amended at 73 tion of this ingredient as generally rec- FR 8606, Feb. 14, 2008] ognized as safe as a direct human food ingredient is based upon the following § 184.1069 Malic acid. current good manufacturing practice (a) Malic acid (C H O , CAS Reg. No. conditions of use: 4 6 5 of L-form 97–67–6, CAS Reg. No. of DL- (1) The ingredient is used as an emul- form 617–48–1) is the common name for sifier as defined in § 170.3(o)(8) of this 1-hydroxy-1, 2-ethanedicarboxylic acid. chapter. L (+) malic acid, referred to as L-malic (2) The ingredient is used at levels acid, occurs naturally in various foods. not to exceed current good manufac- Racemic DL-malic acid does not occur turing practice. naturally. It is made commercially by [61 FR 45889, Aug. 30, 1996] hydration of fumaric acid or maleic acid. § 184.1065 Linoleic acid. (b) The ingredient meets the speci- (a) Linoleic acid ((Z, Z)–9, 12-octadec- fications of the ‘‘Food Chemicals adienoic acid (C17H31COOH) (CAS Reg. Codex,’’ 3d Ed. (1981), pp. 183–184, which No. 60–33–3)), a straight chain unsatu- is incorporated by reference. Copies rated fatty acid with a molecular may be obtained from the National weight of 280.5, is a colorless oil at Academy Press, 2101 Constitution Ave. room temperature. Linoleic acid may NW., Washington, DC 20418, or may be be prepared from edible fats and oils by examined at the National Archives and various methods including hydrolysis Records Administration (NARA). For and saponification, the Twitchell information on the availability of this

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material at NARA, call 202–741–6030, or material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ go to: http://www.archives.gov/ federallregister/ federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (c) The ingredients are used as a fla- (c) In accordance with § 184.1(b)(1), vor enhancer as defined in § 170.3(o)(11) the ingredient is used in food with no of this chapter, flavoring agent and ad- limitation other than current good juvant as defined in § 170.3(o)(12) of this manufacturing practice. The affirma- chapter, and pH control agent as de- tion of this ingredient as generally rec- fined in § 170.3(o)(23) of this chapter. ognized as safe (GRAS) as a direct (d) The ingredients are used in food, human food ingredient is based upon except baby food, at levels not to ex- the following current good manufac- ceed good manufacturing practice in turing practice conditions of use: accordance with § 184.1(b)(1). Current good manufacturing practice results in (1) The ingredient is used as an a maximum level, as served, of 3.4 per- anticaking agent as defined in cent for nonalcoholic beverages as de- § 170.3(o)(1) of this chapter; an anti- fined in § 170.3(n)(3) of this chapter; 3.0 microbial agent as defined in percent for chewing gum as defined in § 170.3(o)(2) of this chapter; a formula- § 170.3(n)(6) of this chapter; 0.8 percent tion aid as defined in § 170.3(o)(14) of for gelatins, puddings, and fillings as this chapter; a humectant as defined in defined in § 170.3(n)(22) of this chapter; § 170.3(o)(16) of this chapter; a leavening 6.9 percent for hard candy as defined in agent as defined in § 170.3(o)(17) of this § 170.3(n)(25) of this chapter; 2.6 percent chapter; A pH control agent as defined for jams and jellies as defined in in § 170.3(o)(23) of this chapter; a proc- § 170.3(n)(28) of this chapter; 3.5 percent essing aid as defined in § 170.3(o)(24) of for processed fruits and fruit juices as this chapter; a stabilizer and thickener defined in § 170.3(n)(35) of this chapter; as defined in § 170.3(o)(28) of this chap- 3.0 percent for soft candy as defined in ter; and a surface-active agent as de- § 170.3(n)(38) of this chapter; and 0.7 per- fined in § 170.3(o)(29) of this chapter. cent for all other food categories. (2) The ingredient is used in the fol- (e) Prior sanctions for malic acid dif- lowing foods at levels not to exceed ferent from the uses established in this current good manufacturing practice: section do not exist or have been baked goods as defined in § 170.3(n)(1) of waived. this chapter; confections and frostings [44 FR 20656, Apr. 6, 1979, as amended at 49 as defined in § 170.3(n)(9) of this chap- FR 5611, Feb. 14, 1984] ter; gelatins and puddings as defined in § 170.3(n)(22) of this chapter; hard candy § 184.1077 Potassium acid tartrate. as defined in § 170.3(n)(25) of this chap-

(a) Potassium acid tartrate (C4H5KO6, ter; jams and jellies as defined in CAS Reg. No. 868–14–4) is the potassium § 170.3(n)(28) of this chapter; and soft acid salt of L¥(+)¥tartaric acid and is candy as defined in § 170.3(n)(38) of this also called potassium bitartrate or chapter. cream of tartar. It occurs as colorless (d) Prior sanctions for this ingredient or slightly opaque crystals or as a different from the uses established in white, crystalline powder. It has a this section do not exist or have been pleasant, acid taste. It is obtained as a waived. byproduct of wine manufacture. (b) The ingredient meets the speci- [48 FR 52446, Nov. 18, 1983] fications of the Food Chemicals Codex, § 184.1081 Propionic acid. 3d Ed. (1981), P. 238, which is incorporated by reference. Copies are avail- (a) Propionic acid (C3H6O2, CAS Reg. able from the National Academy Press, No. 79–09–4) is an oily liquid having a 2101 Constitution Ave. NW., Wash- slightly pungent, rancid odor. It is ington, DC 20418, or available for in- manufactured by chemical synthesis or spection at the National Archives and by bacterial fermentation. Records Administration (NARA). For (b) The ingredient meets the speci- information on the availability of this fications of the Food Chemicals Codex,

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3d Ed. (1981), p. 254, which is incor- and Records Administration (NARA). porated by reference. Copies are avail- For information on the availability of able from the National Academy Press, this material at NARA, call 202–741– 2101 Constitution Ave. NW., Wash- 6030, or go to: http://www.archives.gov/ ington, DC 20418, or available for in- federallregister/ spection at the National Archives and codeloflfederallregulations/ Records Administration (NARA). For ibrllocations.html. information on the availability of this (c) In accordance with § 184.1(b)(1), material at NARA, call 202–741–6030, or the ingredient is used in food with no go to: http://www.archives.gov/ limitation other than current good federallregister/ manufacturing practice. The affirma- codeloflfederallregulations/ tion of this ingredient as generally rec- ibrllocations.html. ognized as safe (GRAS) as a direct (c) In accordance with § 184.1(b)(1), human food ingredient is based upon the ingredient is used in food with no the following current good manufac- limitation other than current good turing practice conditions of use: manufacturing practice. The affirma- (1) The ingredient is used as a fla- tion of this ingredient as generally rec- voring agent and adjuvant as defined in ognized as safe (GRAS) as a direct § 170.3(o)(12) of this chapter. human food ingredient is based upon (2) The ingredient is used in foods at the following current good manufac- levels not to exceed current good man- turing practice conditions of use: ufacturing practice. (1) The ingredient is used as an antimicrobial agent as defined in (d) Prior sanctions for this ingredient § 170.3(o)(2) of this chapter and a fla- different from the uses established in voring agent as defined in § 170.3(o)(12) this section do not exist or have been of this chapter. waived. (2) The ingredient is used in foods at [48 FR 52445, Nov. 18, 1983, as amended at 50 levels not to exceed current good man- FR 49536, Dec. 3, 1985; 69 FR 24512, May 4, ufacturing practice. 2004] (d) Prior sanctions for this ingredient different from the uses established in § 184.1091 Succinic acid. this section do not exist or have been (a) Succinic acid (C4H6O4, CAS Reg. waived. No. 110–15–6), also referred to as amber [49 FR 13141, Apr. 3, 1984] acid and ethylenesuccinic acid, is the chemical 1,4-butanedioic acid. It is § 184.1090 Stearic acid. commercially prepared by hydrogenation of maleic or fumaric acid. It (a) Stearic acid (C18H36O2, CAS Reg. No. 57–11–4) is a white to yellowish can also be produced by aqueous alkali white solid. It occurs naturally as a or acid hydrolysis of succinonitrile. glyceride in tallow and other animal or (b) The ingredient meets the speci- vegetable fats and oils and is a prin- fications of the ‘‘Food Chemicals cipal constituent of most commercially Codex,’’ 3d Ed. (1981), pp. 314–315, which hydrogenated fats. It is produced com- is incorporated by reference. Copies mercially from hydrolyzed tallow de- may be obtained from the National rived from edible sources or from Academy Press, 2101 Constitution Ave. hydrolyzed, completely hydrogenated NW., Washington, DC 20418, or may be vegetable oil derived from edible examined at the National Archives and sources. Records Administration (NARA). For (b) The ingredient meets the speci- information on the availability of this fications of the Food Chemicals Codex, material at NARA, call 202–741–6030, or 3d Ed. (1981), p. 313, which is incor- go to: http://www.archives.gov/ porated by reference, and the require- federallregister/ ments of § 172.860(b)(2) of this chapter. codeloflfederallregulations/ Copies of the Food Chemicals Codex ibrllocations.html. are available from the National Acad- (c) The ingredient is used as a flavor emy Press, 2101 Constitution Ave. NW., enhancer as defined in § 170.3(o)(11) of Washington, DC 20418, or available for this chapter and pH control agent as inspection at the National Archives defined in § 170.3(o)(23) of this chapter.

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(d) The ingredient is used in food at § 170.3(n)(2) of this chapter and 0.0003 levels not to exceed good manufac- percent for cheeses as defined in turing practice in accordance with § 170.3(n)(5) of this chapter. § 184.1(b)(1). Current good manufac- (e) Prior sanctions for this ingredient turing practice results in a maximum different from the uses established in level, as served, of 0.084 percent in con- this section do not exist or have been diments and relishes as defined in waived. § 170.3(n)(8) of this chapter and 0.0061 percent in meat products as defined in [45 FR 6085, Jan. 25, 1980, as amended at 49 § 170.3(n)(29) of this chapter. FR 5611, Feb. 14, 1984] (e) Prior sanctions for this ingredient different from the uses established in § 184.1097 Tannic acid. this section do not exist or have been (a) Tannic acid (CAS Reg. No. 1401– waived. 55–4), or hydrolyzable gallotannin, is a complex polyphenolic organic struc- [44 FR 20657, Apr. 6, 1979, as amended at 49 FR 5611, Feb. 14, 1984] ture that yields gallic acid and either glucose or quinic acid as hydrolysis § 184.1095 Sulfuric acid. products. It is a yellowish-white to light brown substance in the form of an (a) Sulfuric acid (H2SO4, CAS Reg. No. 7664–93–9), also known as oil of vit- amorphous, bulky powder, glistening riol, is a clear, colorless, oily liquid. It scales, or spongy masses. It is also is prepared by reacting sulfur dioxide ordorless, or has a faint characteristic (SO ) with oxygen and mixing the re- odor, and has an astringent taste. Tan- 2 nic acid is obtained by solvent extrac- sultant sulfur trioxide (SO3) with water, or by reacting nitric oxide (NO) tion of nutgalls or excrescences that with sulfur dioxide and water. form on the young twigs of Quercus (b) The ingredient meets the speci- infectoria Oliver and related species of fications of the ‘‘Food Chemicals Quercus. Tannic acid is also obtained Codex,’’ 3d Ed. (1981), pp. 317–318, which by solvent extraction of the seed pods is incorporated by reference. Copies of Tara (Caesalpinia spinosa) or the may be obtained from the National nutgalls of various sumac species, in- Academy Press, 2101 Constitution Ave. cluding Rhus semialata, R. coriaria, R. NW., Washington, DC 20418, or may be galabra, and R. typhia. examined at the National Archives and (b) The ingredient meets the speci- Records Administration (NARA). For fications of the Food Chemicals Codex, information on the availability of this 3d Ed. (1981), p. 319, which is incor- material at NARA, call 202–741–6030, or porated by reference. Copies are avail- go to: http://www.archives.gov/ able from the National Academy Press, federallregister/ 2101 Constitution Ave. NW., Wash- codeloflfederallregulations/ ington, DC 20418, or available for in- ibrllocations.html. spection at the National Archives and (c) The ingredient is used as a pH Records Administration (NARA). For control agent as defined in § 170.3(o)(23) information on the availability of this of this chapter and processing aid as material at NARA, call 202–741–6030, or defined in § 170.3(o)(24) of this chapter. go to: http://www.archives.gov/ (d) The ingredient is used in food at federallregister/ levels not to exceed good manufac- codeloflfederallregulations/ turing practice in accordance with ibrllocations.html. § 184.1(b)(1). Current good manufac- (c)(1) In accordance with § 184.1(b)(2), turing practice results in a maximum the ingredient is used in food only level, as served, of 0.014 percent for al- within the following specific limita- coholic beverages as defined in tions:

Maximum level of use Category of food in food (as Functional use served) (percent)

Baked goods and baking mixes, § 170.3(n)(1) of this 0.01 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter. chapter.

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Maximum level of use Category of food in food (as Functional use served) (percent)

Alcoholic beverages, § 170.3(n)(2) of this chapter ...... 0 .015 Flavor enhancer, § 170.3(o)(11) of this chapter; flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; processing aid, § 170.3(o)(24) of this chapter. Nonalcoholic beverages and beverage bases, 0 .005 Flavoring agent and adjuvant, § 170.3(o)(12) of this § 170.3(n)(3) of this chapter and for gelatins, pud- chapter; pH control agent, § 170.3(o)(23) of this dings, and fillings, § 170.3(n)(22) of this chapter. chapter. Frozen dairy desserts and mixes, § 170.3(n)(20) of this 0 .04 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter and for soft candy, § 170.3(n)(38) of this chapter. chapter. Hard candy and cough drops, § 170.3(n)(25) of this 0.013 Do. chapter. Meat products, § 170.3(n)(29) of this chapter ...... 0.001 Do.

(2) Tannic acid may be used in ren- the following current good manufac- dered animal fat in accordance with 9 turing practice conditions of use: CFR 318.7. (1) The ingredient is used as a firm- (d) Prior sanctions for this ingredient ing agent as defined in § 170.3(o)(10) of different from the uses established in this chapter; a flavor enhancer as de- this section do not exist or have been fined in § 170.3(o)(11) of this chapter; a waived. flavoring agent as defined in [50 FR 21043, May 22, 1985] § 170.3(o)(12) of this chapter; a humectant as defined in § 170.3(o)(16) of this § 184.1099 Tartaric acid. chapter; and a pH control agent as de- (a) Food grade tartaric acid (C4H6O6, fined in § 170.3(o)(23) of this chapter. CAS Reg. No. 87–69–4) has the L con- (2) The ingredient is used in foods at figuration. The L form of tartaric acid levels not to exceed current good man- is dextrorotatory in solution and is ufacturing practice. ¥ ¥ also known as L (+) tartaric acid. (d) Prior sanctions for this ingredient Tartaric acid occurs as colorless or different from the uses established in translucent crystals or as a white, this section do not exist or have been crystalline powder. It is odorless and waived. has an acid taste. It is obtained as a byproduct of wine manufacture. [48 FR 52447, Nov. 18, 1983, as amended at 50 (b) The ingredient meets the speci- FR 49536, Dec. 3, 1985] fications of the Food Chemicals Codex, 3d Ed. (1981), P. 320, which is incor- § 184.1101 Diacetyl tartaric acid esters porated by reference. Copies are avail- of mono- and diglycerides. able from the National Academy Press, (a) Diacetyl tartaric acid esters of 2101 Constitution Ave. NW., Wash- mono- and diglycerides, also know as ington, DC 20418, or available for in- DATEM, are composed of mixed esters spection at the National Archives and of glycerin in which one or more of the Records Administration (NARA). For hydroxyl groups of glycerin has been information on the availability of this esterified by diacetyl tartaric acid and material at NARA, call 202–741–6030, or by fatty acids. The ingredient is pre- go to: http://www.archives.gov/ federallregister/ pared by the reaction of diacetyl tar- codeloflfederallregulations/ taric anhydride with mono- and ibrllocations.html. diglycerides that are derived from edi- (c) In accordance with § 184.1(b)(1), ble sources. the ingredient is used in food with no (b) The ingredient meets the speci- limitation other than current good fications of the Food Chemicals Codex, manufacturing practice. The affirma- 3d. Ed. (1981), pp. 98–99, which is incor- tion of this ingredient as generally rec- porated by reference in accordance ognized as safe (GRAS) as a direct with 5 U.S.C. 552(a). Copies are avail- human food ingredient is based upon able from the National Academy Press,

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2101 Constitution Avenue NW., Wash- (d) Prior sanctions for this ingredient ington, DC 20418, or available for in- different from the uses established in spection at the National Archives and this section do not exist or have been Records Administration (NARA). For waived. information on the availability of this (e) Labeling: The acronym ‘‘DATEM’’ material at NARA, call 202–741–6030, or may be used on food labeling as the al- go to: http://www.archives.gov/ ternate common or usual name for the federallregister/ ingredient diacetyl tartaric acid esters codeloflfederallregulations/ of mono- and diglycerides. ibrllocations.html. [54 FR 7403, Feb. 21, 1989, as amended at 54 (c) In accordance with § 184.1(b)(1), FR 13168, Mar. 31, 1989; 54 FR 18382, Apr. 28, the ingredient is used in food with no 1989; 60 FR 15872, Mar. 28, 1995] limitation other than current good manufacturing practice. The affirma- § 184.1115 Agar-agar. tion of this ingredient as generally rec- (a) Agar-agar (CAS Reg. No. PM 9002– ognized as safe (GRAS) as a direct 18–0) is a dried, hydrophyllic, colloidal human food ingredient is based upon polysaccharide extracted from one of a the following current good manufac- number of related species of red algae turing practice conditions of use: (class Rhodophyceae). (1) The ingredient is used in food as (b) The ingredient meets the specifications of the ‘‘Food Chemicals an emulsifier and emulsifier salt as de- Codex,’’ 3d Ed. (1981), p. 11, which is in- fined in § 170.3(o)(8) of this chapter and corporated by reference. Copies may be a flavoring agent and adjuvant as de- obtained from the National Academy fined in § 170.3(o)(12) of this chapter. Press, 2101 Constitution Ave. NW., (2) The ingredient is used in the fol- Washington, DC 20418, or may be exam- lowing foods at levels not to exceed ined at the National Archives and current good manufacturing practice: Records Administration (NARA). For baked goods and baking mixes as de- information on the availability of this fined in § 170.3(n)(l) of this chapter; material at NARA, call 202–741–6030, or nonalcoholic beverages as defined in go to: http://www.archives.gov/ § 170.3(n)(3) of this chapter; confections federallregister/ and frostings as defined in § 170.3(n)(9) codeloflfederallregulations/ of this chapter; dairy product analogs ibrllocations.html. as defined in § 170.3(n)(10) of this chap- (c) The ingredient is used in food in ter; and fats and oils as defined in accordance with § 184.1(b)(2) under the § 170.3(n)(12) of this chapter. following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Foods (as served) Percent Functions

Baked goods and baking mixes, § 170.3(n)(1) of this chapter 0.8 Drying agent, § 170.3(o)(7) of this chapter; flavoring agent, § 170.3(o)(12) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter. Confections and frostings, § 170.3(n)(9) of this chapter ...... 2.0 Flavoring agent, § 170.3(o)(12) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter; surface finisher, § 170.3(o)(30) of this chapter. Soft candy, § 170.3(n)(38) of this chapter ...... 1.2 Stabilizer and thickener, § 170.3(o)(28) of this chapter. All other food categories ...... 25 Flavoring agent, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; humectant, § 170.3(o)(16) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter.

(d) Prior sanctions for this ingredient § 184.1120 Brown algae. different from the uses established in (a) Brown algae are seaweeds of the this section do not exist or have been species Analipus japonicus, Eisenia waived. bicyclis, Hizikia fusiforme, Kjellmaniella [44 FR 19391, Apr. 3, 1979, as amended at 49 gyrata, Laminaria angustata, Laminaria FR 5611, Feb. 14, 1984]

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claustonia, Laminaria digitata, Lam- ters. The material is dried and ground inaria japonica, Laminaria longicruris, or chopped for use in food. Laminaria longissima, Laminaria (b) The ingredient meets the speci- ochotensis, Laminaria saccharina, fications for kelp in the Food Chemi- Macrocystis pyrifera, Petalonia fascia, cals Codex, 3d Ed. (1981), p. 157, which is Scytosiphon lomentaria and Undaria incorporated by reference, except that pinnatifida. They are harvested prin- the loss on drying is not more than 20 cipally in coastal waters of the north- percent and the maximum allowable ern Atlantic and Pacific oceans. The level for iodine is 0.05 percent. Copies material is dried and ground or are available from the National Acad- chopped for use in food. emy Press, 2101 Constitution Ave. NW., (b) The ingredient meets the speci- Washington, DC 20418, or available for fications for kelp in the Food Chemi- inspection at the National Archives cals Codex, 3d Ed. (1981), p. 157, which is and Records Administration (NARA). incorporated by reference. Copies are For information on the availability of available from the National Academy this material at NARA, call 202–741– Press, 2101 Constitution Ave. NW., 6030, or go to: http://www.archives.gov/ Washington, DC 20418, or available for federallregister/ inspection at the National Archives codeloflfederallregulations/ and Records Administration (NARA). ibrllocations.html. For information on the availability of (c) In accordance with § 184.1(b)(2), this material at NARA, call 202–741– the ingredient is used in food only 6030, or go to: http://www.archives.gov/ within the following specific limita- federallregister/ tions: codeloflfederallregulations/ Maximum level of ibrllocations.html. Category of food use in food (as Functional use (c) In accordance with § 184.1(b)(2), served) the ingredient is used in food only Spices, Not to exceed cur- Flavor enhancer, within the following specific limita- seasonings, and rent good manu- § 170.3(o)(11) of flavorings, facturing prac- this chapter; fla- tions: § 170.3(n) (26) tice. vor adjuvant, of this chapter. § 170.3(o)(12) of Maximum level of this chapter. Category of food use in food (as Functional use served) (d) Prior sanctions for this ingredient Spices, Not to exceed cur- Flavor enhancer, different from the use established in seasonings, and rent good manu- § 170.3(o)(11) of this section do not exist or have been flavorings, facturing prac- this chapter; fla- § 170.3(n) (26) tice. vor adjuvant, waived. of this chapter. § 170.3(o)(12) of this chapter. [47 FR 47376, Oct. 26, 1982]

(d) Prior sanctions for this ingredient § 184.1133 Ammonium alginate. different from the use established in (a) Ammonium alginate (CAS Reg. this section do not exist or have been No. 9005–34–9) is the ammonium salt of waived. alginic acid, a natural polyuronide constituent of certain brown algae. Ammo- [47 FR 47376, Oct. 26, 1982] nium alginate is prepared by the neutralization of purified alginic acid with § 184.1121 Red algae. appropriate pH control agents. (a) Red algae are seaweeds of the spe- (b) The ingredient meets the speci- cies Gloiopeltis furcata, Porphyra fications of the Food Chemicals Codex, crispata, Porphyra deutata, Porphyra 3d Ed. (1981), p. 18, which is incor- perforata, Porphyra suborbiculata, porated by reference. Copies are avail- Porphyra tenera and Rhodymenia able from the National Academy Press, palmata. Porphyra and Rhodymenia are 2101 Constitution Ave. NW., Wash- harvested principally along the coasts ington, DC 20418, or available for in- of Japan, Korea, China, Taiwan, and spection at the National Archives and the East and West coasts of the United Records Administration (NARA). For States. Gloiopeltis is harvested prin- information on the availability of this cipally in southern Pacific coastal wa- material at NARA, call 202–741–6030, or

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go to: http://www.archives.gov/ go to: http://www.archives.gov/ federallregister/ federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (c) In accordance with § 184.1(b)(2), (c) In accordance with § 184.1(b)(1), the ingredient is used in food only the ingredient is used in food with no within the following specific limita- limitation other than current good tions: manufacturing practice. The affirmation of this ingredient as generally rec- Maximum level of ognized as safe (GRAS) as a direct use in human food ingredient is based upon Category of food food (as Functional use served) the following current good manufac- (percent) turing practice conditions of use: (1) The ingredient is used as a dough Confections, frostings, 0.4 Stabilizer, thickener, § 170.3(n)(9) of this § 170.3(o)(28) of this strengthener as defined in § 170.3(o)(6) chapter. chapter. of this chapter; a leavening agent as Fats and oils, 0.5 Do. defined in § 170.3(o)(17) of this chapter; § 170.3(n)(12) of this chapter. a pH control agent as defined in Gelatins, puddings, 0.5 Do. § 170.3(o)(23) of this chapter; and a § 170.3(n)(22) of this texturizer as defined in § 170.3(o)(32) of chapter. this chapter. Gravies and sauces, 0.4 Do. § 170.3(n)(24) of this (2) The ingredient is used in food at chapter. levels not to exceed current good man- Jams and jellies, 0.4 Do. ufacturing practice. § 170.3(n)(28) of this chapter. (d) Prior sanctions for this ingredient Sweet sauces, 0.5 Do. different from the uses established in § 170.3(n)(43) of this this section do not exist or have been chapter. All other food cat- 0.1 Humectant, waived. egories. § 170.3(o)(16) of this [48 FR 52439, Nov. 18, 1983] chapter; stabilizer, thickener, § 170.3(o)(28) of this § 184.1137 Ammonium carbonate. chapter. (a) Ammonium carbonate ((NH4)2CO3, CAS Reg. No. 8000–73–5) is a mixture of (d) Prior sanctions for ammonium al- ammonium bicarbonate (NH HCO ) and ginate different from the uses estab- 4 3 ammonium carbamate (NH COONH ). lished in this section do not exist or 2 4 It is prepared by the sublimation of a have been waived. mixture of ammonium sulfate and cal- [47 FR 29950, July 9, 1982] cium carbonate and occurs as a white powder or a hard, white or translucent § 184.1135 Ammonium bicarbonate. mass. (a) Ammonium bicarbonate (b) The ingredient meets the speci- (NH4HCO3, CAS Reg. No. 1066–33–7) is fications of the Food Chemicals Codex, prepared by reacting gaseous carbon di- 3d Ed. (1981), p. 19, which is incor- oxide with aqueous ammonia. Crystals porated by reference. Copies are avail- of ammonium bicarbonate are precip- able from the National Academy Press, itated from solution and subsequently 2101 Constitution Ave. NW., Wash- washed and dried. ington, DC 20418, or available for in- (b) The ingredient meets the speci- spection at the National Archives and fications of the Food Chemicals Codex, Records Administration (NARA). For 3d Ed. (1981), p. 19, which is incor- information on the availability of this porated by reference. Copies are avail- material at NARA, call 202–741–6030, or able from the National Academy Press, go to: http://www.archives.gov/ 2101 Constitution Ave. NW., Wash- federallregister/ ington, DC 20418, or available for in- codeloflfederallregulations/ spection at the National Archives and ibrllocations.html. Records Administration (NARA). For (c) In accordance with § 184.1(b)(1), information on the availability of this the ingredient is used in food with no material at NARA, call 202–741–6030, or limitation other than current good

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manufacturing practice. The affirma- of this chapter; a flavor enhancer as de- tion of this ingredient as generally rec- fined in § 170.3(o)(11) of this chapter; a ognized as safe (GRAS) as a direct leavening agent as defined in human food ingredient is based upon § 170.3(o)(17) of this chapter; and a proc- the following current good manufac- essing aid as defined in § 107.3(o)(24) of turing practice conditions of use: this chapter. (1) The ingredient is used as a leav- (2) The ingredient is used in food at ening agent as defined in § 170.3(o)(17) of levels not to exceed current good man- this chapter and a pH control agent as ufacturing practice. defined in § 170.3(o)(23) of this chapter. (d) Prior sanctions for this ingredient (2) The ingredient is used in food at different from the uses established in levels not to exceed current good man- this section do not exist or have been ufacturing practice. waived. (d) Prior sanctions for this ingredient [48 FR 52439, Nov. 18, 1983] different from the uses established in this section do not exist or have been § 184.1139 Ammonium hydroxide. waived. (a) Ammonium hydroxide (NH4OH, [48 FR 52439, Nov. 18, 1983] CAS Reg. No. 1336–21–6) is produced by passing ammonia gas into water. § 184.1138 Ammonium chloride. (b) The ingredient meets the speci- (a) Ammonium chloride (NH4Cl, CAS fications of the Food Chemicals Codex, Reg. No. 12125–02–9) is produced by the 3d Ed. (1981), p. 20, which is incor- reaction of sodium chloride and an am- porated by reference. Copies are avail- monium salt in solution. The less solu- able from the National Academy Press, ble sodium salt separates out at ele- 2101 Constitution Ave. NW., Wash- vated temperatures, and ammonium ington, DC 20418, or available for in- chloride is recovered from the filtrate spection at the National Archives and on cooling. Alternatively, hydrogen Records Administration (NARA). For chloride formed by the burning of hy- information on the availability of this drogen in chlorine is dissolved in water material at NARA, call 202–741–6030, or and then reacted with gaseous ammo- go to: http://www.archives.gov/ nia. Ammonium chloride is crystallized federallregister/ from the solution. codeloflfederallregulations/ (b) The ingredient meets the speci- ibrllocations.html. fications of the Food Chemicals Codex, (c) In accordance with § 184.1(b)(1), 3d Ed. (1981), p. 20, which is incor- the ingredient is used in food with no porated by reference. Copies are avail- limitation other than current good able from the National Academy Press, manufacturing practice. The affirma- 2101 Constitution Ave, NW., Wash- tion of this ingredient as generally rec- ington, DC 20418, or available for in- ognized as safe (GRAS) as a direct spection at the National Archives and human food ingredient is based upon Records Administration (NARA). For the following current good manufac- information on the availability of this turing practice conditions of use: material at NARA, call 202–741–6030, or (1) The ingredient is used as a leav- go to: http://www.archives.gov/ ening agent as defined in § 170.3(o)(17) of federallregister/ this chapter; a pH control agent as de- codeloflfederallregulations/ fined in § 170.3(o)(23) of this chapter; a ibrllocations.html. surface-finishing agent as defined in (c) In accordance with § 184.1(b)(1), § 170.3(o)(30) of this chapter; and as a the ingredient is used in food with no boiler water additive complying with limitation other than current good § 173.310 of this chapter. manufacturing practice. The affirma- (2) The ingredient is used in food at tion of this ingredient as generally rec- levels not to exceed current good man- ognized as safe (GRAS) as a direct ufacturing practice. The ingredient human food ingredient is based upon may also be used as a boiler water ad- the following current good manufac- ditive at levels not to exceed current turing practice conditions of use: good manufacturing practice. (1) The ingredient is used as a dough (d) Prior sanctions for this ingredient strengthener as defined in § 170.3(o)(6) different from the uses established in

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this section do not exist or have been go to: http://www.archives.gov/ waived. federallregister/ codeloflfederallregulations/ [48 FR 52440, Nov. 18, 1983, as amended at 59 FR 14551, Mar. 29, 1994] ibrllocations.html. (c) In accordance with § 184.1(b)(1), § 184.1140 Ammonium citrate, dibasic. the ingredient is used in food with no limitation other than current good (a) Ammonium citrate, dibasic manufacturing practice. The affirma- ((NH4)2HC6H5O7, CAS Reg. No. 3012–65–5) tion of this ingredient as generally rec- is the diammonium salt of citric acid. ognized as safe (GRAS) as a direct It is prepared by partially neutralizing human food ingredient is based upon citric acid with ammonia. the following current good manufac- (b) The ingredient must be of a pu- turing practice conditions of use: rity suitable for its intended use. (1) The ingredient is used as a dough (c) In accordance with § 184.1(b)(1), strengthener as defined in § 170.3(o)(6) the ingredient is used in food with no of this chapter and a pH control agent limitation other than current good as defined in § 170.3(o)(23) of this chap- manufacturing practice. The affirma- ter. tion of this ingredient as generally rec- (2) The ingredient is used in food at ognized as safe (GRAS) as a direct levels not to exceed current good man- human food ingredient is based upon ufacturing practice. the following current good manufac- (d) Prior sanctions for this ingredient turing practice conditions of use: different from the uses established in (1) The ingredient is used as a flavor this section do not exist or have been enhancer as defined in § 170.3(o)(11) of waived. this chapter and as a pH control agent as defined in § 170.3(o)(23) of this chap- [48 FR 52440, Nov. 18, 1983] ter. § 184.1141b Ammonium phosphate, di- (2) The ingredient is used in non- basic. alcoholic beverages as defined in (a) Ammonium phosphate, dibasic § 170.3(n)(3) of this chapter and in ((NH ) HPO , CAS Reg. No. 7783–28–0) is cheeses as defined in § 170.3(n)(5) of this 4 2 4 manufactured by reacting ammonia chapter at levels not to exceed current with phosphoric acid at a pH above 5.8. good manufacturing practice. (b) The ingredient meets the speci- (d) Prior sanctions for this ingredient fications of the Food Chemicals Codex, different from the uses established in 3d Ed. (1981), p. 21, which is incor- this section, or different from those set porated by reference. Copies are avail- forth in part 181 of this chapter, do not able from the National Academy Press, exist or have been waived. 2101 Constitution Ave. NW., Wash- [59 FR 63896, Dec. 12, 1994, as amended at 73 ington, DC 20418, or available for in- FR 8606, Feb. 14, 2008] spection at the National Archives and Records Administration (NARA). For § 184.1141a Ammonium phosphate, information on the availability of this monobasic. material at NARA, call 202–741–6030, or (a) Ammonium phosphate, monobasic go to: http://www.archives.gov/ (NH4H2PO4, CAS Reg. No. 7722–76–1) is federallregister/ manufactured by reacting ammonia codeloflfederallregulations/ with phosphoric acid at a pH below 5.8. ibrllocations.html. (b) The ingredient meets the speci- (c) In accordance with § 184.1(b)(1), fications of the Food Chemicals Codex, the ingredient is used in food with no 3d Ed. (1981), p. 21, which is incor- limitation other than current good porated by reference. Copies are avail- manufacturing practice. The affirma- able from the National Academy Press, tion of this ingredient as generally rec- 2101 Constitution Ave. NW., Wash- ognized as safe (GRAS) as a direct ington, DC 20418, or available for in- human food ingredient is based upon spection at the National Archives and the following current good manufac- Records Administration (NARA). For turing practice conditions of use: information on the availability of this (1) The ingredient is used as a dough material at NARA, call 202–741–6030, or strengthener as defined in § 170.3(o)(6)

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of this chapter; a firming agent as de- this section do not exist or have been fined in § 170.3(o)(10) of this chapter; a waived. leavening agent as defined in [45 FR 6086, Jan. 25, 1980; 45 FR 16469, Mar. 14, § 170.3(o)(17) of this chapter; a pH con- 1980, as amended at 49 FR 5611, Feb. 14, 1984] trol agent as defined in § 170.3(o)(23) of this chapter; and a processing aid as § 184.1148 Bacterially-derived defined in § 170.3(o)(24) of this chapter. carbohydrase enzyme preparation. (2) The ingredient is used in food at (a) Bacterially-derived carbohydrase levels not to exceed current good man- enzyme preparation is obtained from ufacturing practice. the culture filtrate resulting from a (d) Prior sanctions for this ingredient pure culture fermentation of a non- different from the uses established in pathogenic and nontoxigenic strain of this section do not exist or have been Bacillus subtilis or B. amyloliquefaciens. waived. The preparation is characterized by the presence of the enzymes a-amylase (EC [48 FR 52440, Nov. 18, 1983] 3.2.1.1) and b-glucanase (EC 3.2.1.6), § 184.1143 Ammonium sulfate. which catalyze the hydrolysis of O- glycosyl bonds in carbohydrates. (a) Ammonium sulfate ((NH4)2SO4, (b) The ingredient meets the general CAS Reg. No. 7783–20–2) occurs natu- requirements and additional require- rally and consists of colorless or white, ments in the monograph on enzyme odorless crystals or granules. It is pre- preparations in the Food Chemicals pared by the neutralization of sulfuric Codex, 4th ed. (1996), pp. 128–135, which acid with ammonium hydroxide. is incorporated by reference in accord- (b) The ingredient meets the speci- ance with 5 U.S.C. 552(a) and 1 CFR fications of the ‘‘Food Chemicals part 51. Copies are available from the Codex,’’ 3d Ed. (1981), pp. 22–23, which is National Academy Press, 2101 Constitu- incorporated by reference. Copies may tion Ave. NW., Washington, DC 20418, be obtained from the National Acad- or may be examined at the Center for emy Press, 2101 Constitution Ave. NW., Food Safety and Applied Nutrition’s Washington, DC 20418, or may be exam- Library, 5100 Paint Branch Pkwy., Col- ined at the National Archives and lege Park, MD 20740, or at the National Records Administration (NARA). For Archives and Records Administration information on the availability of this (NARA). For information on the avail- material at NARA, call 202–741–6030, or ability of this material at NARA, call go to: http://www.archives.gov/ 202–741–6030, or go to: http:// federallregister/ www.archives.gov/federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. In addition, anti- (c) The ingredient is used as a dough biotic activity is absent in the enzyme strengthener as defined in § 170.3(o)(6) preparation when determined by an ap- of this chapter, firming agent as de- propriate validated method such as the fined in § 170.3(o)(10) of this chapter, method ‘‘Determination of antibiotic activity’’ in the Compendium of Food and processing aid as defined in Additive Specifications, vol. 2, Joint § 170.3(o)(24) of this chapter. FAO/WHO Expert Committee on Food (d) The ingredient is used in food at Additives (JECFA), Food and Agri- levels not to exceed good manufac- culture Organization of the United Na- turing practice in accordance with tions, Rome, 1992. Copies are available § 184.1(b)(1). Current good manufac- from Bernan Associates, 4611–F Assem- turing practice results in a maximum bly Dr., Lanham, MD 20706, or from The level, as served, of 0.15 percent for United Nations Bookshop, General As- baked goods as defined in § 170.3(n)(1) of sembly Bldg., rm. 32, New York, NY this chapter and 0.1 percent for gela- 10017, or by inquiries sent to http:// tins and puddings as defined in www.fao.org. Copies may be examined § 170.1(n)(22) of this chapter. at the Center for Food Safety and Ap- (e) Prior sanctions for this ingredient plied Nutrition’s Library, 5100 Paint different from the uses established in Branch Pkwy., College Park, MD 20740.

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(c) In accordance with § 184.1(b)(1), culture Organization of the United Na- the ingredient is used in food with no tions, Rome, 1992. Copies are available limitation other than current good from Bernan Associates, 4611–F Assem- manufacturing practice. The affirma- bly Dr., Lanham, MD 20706, or from The tion of this ingredient as GRAS as a di- United Nations Bookshop, General As- rect food ingredient is based upon the sembly Bldg., rm. 32, New York, NY following current good manufacturing 10017, or by inquiries sent to http:// practice conditions of use: www.fao.org. Copies may be examined (1) The ingredient is used as an en- at the Center for Food Safety and Ap- zyme as defined in § 170.3(o)(9) of this plied Nutrition’s Library, 5100 Paint chapter to hydrolyze polysaccharides (e.g., starch). Branch Pkwy., College Park, MD 20740. (2) The ingredient is used in food at (c) In accordance with § 184.1(b)(1), levels not to exceed current good man- the ingredient is used in food with no ufacturing practice. limitation other than current good manufacturing practice. The affirma- [64 FR 19894, Apr. 23, 1999] tion of this ingredient as GRAS as a di- § 184.1150 Bacterially-derived protease rect food ingredient is based upon the enzyme preparation. following current good manufacturing (a) Bacterially-derived protease en- practice conditions of use: zyme preparation is obtained from the (1) The ingredient is used as an en- culture filtrate resulting from a pure zyme as defined in § 170.3(o)(9) of this culture fermentation of a nonpatho- chapter to hydrolyze proteins or genic and nontoxigenic strain of Bacil- polypeptides. lus subtilis or B. amyloliquefaciens. The (2) The ingredient is used in food at preparation is characterized by the levels not to exceed current good man- presence of the enzymes subtilisin (EC ufacturing practice. 3.4.21.62) and neutral proteinase (EC 3.4.24.28), which catalyze the hydrolysis [64 FR 19895, Apr. 23, 1999] of peptide bonds in proteins. (b) The ingredient meets the general § 184.1155 Bentonite. requirements and additional require- (a) Bentonite (Al2O34SiO2nH2O, CAS ments in the monograph on enzyme Reg. No. 1302–0978–099) is principally a preparations in the Food Chemicals colloidal hydrated aluminum silicate. Codex, 4th ed. (1996), pp. 128–135, which Bentonite contains varying quantities is incorporated by reference in accord- of iron, alkalies, and alkaline earths in ance with 5 U.S.C. 552(a) and 1 CFR the commercial products. Depending on part 51. Copies are available from the the cations present, natural deposits of National Academy Press, 2101 Constitu- bentonite range in color from white to tion Ave. NW., Washington, DC 20418, gray, yellow, green, or blue. or may be examined at the Center for Bentonite’s fine particles provide large Food Safety and Applied Nutrition’s total surface area and, hence, pro- Library, 5100 Paint Branch Pkwy., Col- lege Park, MD 20740, or at the National nounced adsorptive capability. Archives and Records Administration (b) The ingredient must be of a pu- (NARA). For information on the avail- rity suitable for its intended use. ability of this material at NARA, call (c) In accordance with § 184.1(b)(1), 202–741–6030, or go to: http:// the ingredient is used in food with no www.archives.gov/federallregister/ limitation other than current good codeloflfederallregulations/ manufacturing practice. The affirma- ibrllocations.html. In addition, anti- tion of this ingredient as generally rec- biotic activity is absent in the enzyme ognized as safe (GRAS) as a direct preparation when determined by an ap- human food ingredient is based upon propriate validated method such as the the following current good manufac- method ‘‘Determination of antibiotic turing practice conditions of use: activity’’ in the Compendium of Food (1) The ingredient is used as a proc- Additive Specifications, vol. 2, Joint essing aid as defined in § 170.3(o)(24) of FAO/WHO Expert Committee on Food this chapter. Additives (JECFA), Food and Agri-

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(2) The ingredient is used in food at chapter; and annatto-colored whey, levels not to exceed current good man- such that the final bleached product ufacturing practice. Current good man- conforms to the descriptions and speci- ufacturing practice results in no sig- fications for whey, concentrated whey, nificant residue in foods. or dried whey in § 184.1979(a) (1), (2), or (d) Prior sanctions for this ingredient (3), respectively. different from the uses established in (d) Prior sanctions for this ingredient this section do not exist or have been different from the uses established in waived. this section do not exist or have been [47 FR 43367, Oct. 1, 1982, as amended at 73 FR waived. 8606, Feb. 14, 2008] [51 FR 27173, July 30, 1986]

§ 184.1157 Benzoyl peroxide. § 184.1165 n-Butane and iso-butane. (a) Benzoyl peroxide ((C6H5CO)2O2, (a) n-Butane and iso-butane (empir- CAS Reg. No. 94–36–0) is a colorless, ical formula C4H10, CAS Reg. Nos. 106– rhombic crystalline solid. It is pre- 97–8 and 75–28–5, respectively) are color- pared by reaction of benzoyl chloride, less, odorless, flammable gases at nor- sodium hydroxide, and hydrogen per- mal temperatures and pressures. They oxide. are easily liquefied under pressure at (b) The ingredient meets the speci- room temperature and are stored and fications of the Food Chemicals Codex, shipped in the liquid state. The butanes 3d Ed. (1981), p. 35, which is incor- are obtained from natural gas by frac- porated by reference. Copies are avail- tionation following absorption in oil, able from the National Academy Press, adsorption to surface-active agents, or 2101 Constitution Ave. NW., Wash- refrigeration. ington, DC 20418, or available for in- (b) The ingredients must be of a pu- spection at the National Archives and rity suitable for their intended use. Records Administration (NARA). For (c) In accordance with § 184.1(b)(1), information on the availability of this these ingredients are used in food with material at NARA, call 202–741–6030, or no limitations other than current good go to: http://www.archives.gov/ manufacturing practice. The affirma- federallregister/ tion of these ingredients as generally codeloflfederallregulations/ recognized as safe (GRAS) as direct ibrllocations.html. human food ingredients is based upon (c) In accordance with § 184.1(b)(1), the following current good manufac- the ingredient is used in food with no turing practice conditions of use: limitation other than current good (1) The ingredients are used as pro- manufacturing practice. The affirma- pellants, aerating agents, and gases as tion of this ingredient as generally rec- defined in § 170.3(o)(25) of this chapter. ognized as safe (GRAS) as a direct (2) The ingredients are used in food human food ingredient is based upon at levels not to exceed current good the following current good manufac- manufacturing practice. turing practice conditions of use: (d) Prior sanctions for these ingredi- (1) The ingredient is used as a bleach- ents different from the uses established ing agent in food. (2) The ingredient is used in the fol- in this section do not exist or have lowing foods at levels not to exceed been waived. current good manufacturing practice: [48 FR 57270, Dec. 29, 1983, as amended at 73 flour; milk used for production of FR 8607, Feb. 14, 2008] Asiago fresh and Asiago soft cheese (§ 133.102), Asiago medium cheese § 184.1185 Calcium acetate. (§ 133.103), Asiago old cheese (§ 133.104), (a) Calcium acetate (Ca (C2H3O2)2, Blue cheese (§ 133.106), Caciocavallo CAS Reg. No. 62–54–4), also known as siciliano chesse (§ 133.111), Gorgonzola acetate of lime or vinegar salts, is the cheese (§ 133.141), Parmesan and calcium salt of acetic acid. It may be reggiano cheese (§ 133.165), Provolone produced by the calcium hydroxide cheese (§ 133.181), Romano cheese neutralization of acetic acid. (§ 133.183), and Swiss and emmentaler (b) The ingredient meets the speci- cheese (§ 133.195) in part 133 of this fications of the Food Chemicals Codex,

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3d Ed. (1981), p. 44, which is incorporated by reference. Copies are avail- porated by reference. Copies are available from the National Academy Press, able from the National Academy Press, 2101 Constitution Ave. NW., Wash- 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- ington, DC 20418, or available for inspection at the National Archives and spection at the National Archives and Records Administration (NARA). For Records Administration (NARA). For information on the availability of this information on the availability of this material at NARA, call 202–741–6030, or material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ go to: http://www.archives.gov/ federallregister/ federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (c) In accordance with § 184.1(b)(2), (c) The ingredient is used as a firm- the ingredient is used in food only ing agent as defined in § 170.3(o)(10) of within the following specific limita- this chapter; pH control agent as de- tions: fined in § 170.3(o)(23) of this chapter; processing aid as defined in § 170.3(o)(24) Maximum level of of this chapter; sequestrant as defined use in in § 170.3(o)(26) of this chapter; sta- Category of food food (as Functional use served) bilizer and thickener as defined in (percent) § 170.3(o)(28) of this chapter; and texturizer as defined in § 170.3(o)(32) of Baked goods, 0.002 Stabilizer, thickener, § 170.3(n)(1) of this § 170.3(o)(28) of this this chapter. chapter. chapter. (d) The ingredient is used in food at Alcoholic beverages, 0.4 Do. levels not to exceed current good man- § 170.3(n)(2) of this ufacturing practices in accordance chapter. Confections and 0.4 Do. with § 184.1(b)(1). Current good manu- frostings, facturing practices result in a max- § 170.3(n)(9) of this imum level, as served, of 0.2 percent for chapter. baked goods as defined in § 170.3(n)(1) of Egg products, 0.6 Do. § 170.3(n)(11) of this this chapter; 0.02 percent for cheese as chapter. defined in § 170.3(n)(5) of this chapter; Fats and oils, 0.5 Do. 0.2 percent for gelatins, puddings, and § 170.3(n)(12) of this fillings as defined in § 170.3(n)(22) of chapter. Gelatins, puddings, 0.25 Do. this chapter; 0.15 percent for sweet § 170.3(n)(22) of this sauces, toppings, and syrups as defined chapter. in § 170.3(n)(43) of this chapter; and Gravies and sauces, 0.4 Do. 0.0001 percent for all other food cat- § 170.3(n)(24) of this chapter. egories. Jams and jellies, 0.5 Do. (e) Prior sanctions for this ingredient § 170.3(n)(28) of this different from the uses established in chapter. this section or in part 181 of this chap- Sweet sauces, 0.5 Do. § 170.3(n)(43) of this ter do not exist or have been waived. chapter. [47 FR 27807, June 25, 1982] All other food cat- 0.3 Do. egories. § 184.1187 Calcium alginate. (d) Prior sanctions for calcium algi- (a) Calcium alginate (CAS Reg. No. nate different from the uses established 9005–35–0) is the calcium salt of alginic in this section do not exist or have acid, a natural polyuronide constituent been waived. of certain brown algae. Calcium alginate is prepared by the neutralization [47 FR 29951, July 9, 1982] of purified alginic acid with appropriate pH control agents, or from so- § 184.1191 Calcium carbonate. dium alginate by metathesis with ap- (a) Calcium carbonate (CaCO3, CAS propriate calcium salts. Reg. No. 471–34–1) is prepared by three (b) The ingredient meets the speci- common methods of manufacture: fications of the Food Chemicals Codex, (1) As a byproduct in the ‘‘Lime soda 3d Ed. (1981), p. 45, which is incor- process’’;

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(2) By precipitation of calcium car- (c) The ingredient is used as an bonate from calcium hydroxide in the anticaking agent as defined in ‘‘Carbonation process’’; or § 170.3(o)(1) of this chapter; anti- (3) By precipitation of calcium car- microbial agent as defined in bonate from calcium chloride in the § 170.3(o)(2) of this chapter; curing or ‘‘Calcium chloride process’’. pickling agent as defined in § 170.3(o)(5) (b) The ingredient meets the speci- of this chapter; firming agent as de- fications of the Food Chemicals Codex, fined in § 170.3(o)(10) of this chapter; 3d Ed. (1981), p. 46, which is incor- flavor enhancer as defined in porated by reference. Copies are avail- § 170.3(o)(11) of this chapter; humectant able from the National Academy Press, as defined in § 170.3(o)(16) of this chap- 2101 Constitution Ave. NW., Wash- ter; nutrient supplement as defined in ington, DC 20418, or available for in- § 170.3(o)(20) of this chapter; pH control spection at the National Archives and agent as defined in § 170.3(o)(23) of this Records Administration (NARA). For chapter; processing aid as defined in information on the availability of this § 170.3(o)(24) of this chapter; stabilizer material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ and thickener as defined in § 170.3(o)(28) federallregister/ of this chapter; surface-active agent as codeloflfederallregulations/ defined in § 170.3(o)(29) of this chapter; ibrllocations.html. synergist as defined in § 170.3(o)(31) of (c) In accordance with § 184.1(b)(1), this chapter; and texturizer as defined the ingredient is used in food with no in § 170.3(o)(32) of this chapter. limitation other than current good (d) The ingredient is used in foods at manufacturing practice. levels not to exceed current good man- (d) Prior sanctions for this ingredient ufacturing practices in accordance different from the uses established in with § 184.1(b)(1). Current good manu- this section, or different from that set facturing practices result in a max- forth in part 181 of this chapter, do not imum level, as served, of 0.3 percent for exist or have been waived. baked goods as defined in § 170.3(n)(1) of [48 FR 52441, Nov. 18, 1983] this chapter and for dairy product analogs as defined in § 170.3(n)(10) of § 184.1193 Calcium chloride. this chapter; 0.22 percent for nonalcoholic beverages and beverage bases (a) Calcium chloride (CaCl2·2H2O, CAS Reg. No. 10035–04–8) or anhydrous as defined in § 170.3(n)(3) of this chapter; 0.2 percent for cheese as defined in calcium chloride (CaCl2, CAS Reg. No. 10043–52–4) may be commercially ob- § 170.3(n)(5) of this chapter and for proc- tained as a byproduct in the ammonia- essed fruit and fruit juices as defined in soda (Solvay) process and as a joint § 170.3(n)(35) of this chapter; 0.32 per- product from natural salt brines, or it cent for coffee and tea as defined in may be prepared by substitution reac- § 170.3(n)(7) of this chapter; 0.4 percent tions with other calcium and chloride for condiments and relishes as defined salts. in § 170.3(n)(8) of this chapter; 0.2 per- (b) The ingredient meets the speci- cent for gravies and sauces as defined fications of the Food Chemicals Codex, in § 170.3(n)(24) of this chapter; 0.1 per- 3d Ed. (1981), p. 47, which is incor- cent for commercial jams and jellies as porated by reference. Copies are avail- defined in § 170.3(n)(28) of this chapter; able from the National Academy Press, 0.25 percent for meat products as de- 2101 Constitution Ave. NW., Wash- fined in § 170.3(n)(29) of this chapter; 2.0 ington, DC 20418, or available for in- percent for plant protein products as spection at the National Archives and defined in § 170.3(n)(33) of this chapter; Records Administration (NARA). For 0.4 percent for processed vegetables and information on the availability of this vegetable juices as defined in material at NARA, call 202–741–6030, or § 170.3(n)(36) of this chapter; and 0.05 go to: http://www.archives.gov/ percent for all other food categories. federallregister/ (e) Prior sanctions for this ingredient codeloflfederallregulations/ different from the uses established in ibrllocations.html.

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this section do not exist or have been 3d Ed. (1981), p. 51, which is incor- waived. porated by reference. Copies are available from the National Academy Press, [47 FR 27808, June 25, 1982, as amended at 61 FR 14247, Apr. 1, 1996] 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- § 184.1195 Calcium citrate. spection at the National Archives and (a) Calcium citrate Records Administration (NARA). For information on the availability of this (Ca3(C6H5O7)2·4H2O, CAS Reg. No. 813– 0994–095) is the calcium salt of citric material at NARA, call 202–741–6030, or acid. It is prepared by neutralizing cit- go to: http://www.archives.gov/ ric acid with calcium hydroxide or cal- federallregister/ cium carbonate. It occurs as a fine codeloflfederallregulations/ white, odorless powder and usually ibrllocations.html. contains four moles of water per mole (c) The ingredient is used as a firm- of calcium citrate. ing agent as defined in § 170.3(o)(10) of (b) The ingredient meets the speci- this chapter; formulation aid as defined fications of the Food Chemicals Codex, in § 170.3(o)(14) of this chapter; 3d ed. (1981), pp. 49 and 50, which is in- sequestrant as defined in § 170.3(o)(26) of corporated by reference in accordance this chapter; stabilizer or thickener as with 5 U.S.C. 552(a) and 1 CFR part 51. defined in § 170.3(o)(28) of this chapter; Copies are available from the National and texturizer as defined in § 170.3(o)(32) Academy Press, 2101 Constitution Ave. of this chapter. NW., Washington, DC 20418, and the (d) The ingredient is used in foods at Center for Food Safety and Applied Nu- levels not to exceed current good man- trition (HFS–200), 5100 Paint Branch ufacturing practices in accordance Pkwy., College Park, MD 20740, or may with § 184.1(b)(1). Current good manu- be examined at the National Archives facturing practices result in a max- and Records Administration (NARA). imum level, as served, of 1.75 percent For information on the availability of for baked goods as defined in this material at NARA, call 202–741– § 170.3(n)(1) of this chapter; 0.4 percent 6030, or go to: http://www.archives.gov/ for dairy product analogs as defined in federallregister/ § 170.3(n)(10) of this chapter; 4.5 percent codeloflfederallregulations/ for gelatins and puddings as defined in ibrllocations.html. § 170.3(n)(22) of this chapter; and 0.01 (c) In accordance with § 184.1(b)(1), percent for sugar substitutes as defined the ingredient is used in food with no in § 170.3(n)(42) of this chapter. limitation other than current good (e) Prior sanctions for this ingredient manufacturing practice. Calcium cit- different from the uses established in rate may also be used in infant formula this section do not exist or have been in accordance with section 412(g) of the waived. Federal Food, Drug, and Cosmetic Act [47 FR 27808, June 25, 1982] (the act) or with regulations promulgated under section 412(a)(2) of the act. § 184.1201 Calcium glycerophosphate. (d) Prior sanctions for this ingredient (a) Calcium glycerophosphate different from the uses established in (C H CaO P, CAS Reg. No. 27214–00–2) is this section do not exist or have been 3 7 6 a fine, white, odorless, almost taste- waived. less, slightly hygroscopic powder. It is [59 FR 63896, Dec. 12, 1994] prepared by neutralizing glycero- phosphoric acid with calcium hydrox- § 184.1199 Calcium gluconate. ide or calcium carbonate. The commer- (a) Calcium gluconate cial product is a mixture of calcium b- ([CH2OH(CHOH)4COO]2Ca, CAS Reg. No. , and D-, and L-a-glycerophosphate. 299–28–5) is the calcium salt of gluconic (b) The ingredient meets the speci- acid which may be produced by neu- fications of the ‘‘Food Chemicals tralization of gluconic acid with lime Codex,’’ 3d Ed. (1981), pp. 51–52, which is or calcium carbonate. incorporated by reference in accord- (b) The ingredient meets the speci- ance with 5 U.S.C. 552(a) and 1 CFR fications of the Food Chemicals Codex, part 51. Copies may be obtained from

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the National Academy Press, 2101 Con- this section do not exist or have been stitution Ave. NW., Washington, DC waived. 20418, or may be examined at the Na- [49 FR 26714, June 29, 1984] tional Archives and Records Adminis- tration (NARA). For information on § 184.1206 Calcium iodate. the availability of this material at (a) Calcium iodate [Ca(IO ) ·H O, CAS NARA, call 202–741–6030, or go to: http:// 3 2 2 Reg. No. 7789–80–2], also referred to as www.archives.gov/federallregister/ lautarite, does not occur naturally but codeloflfederallregulations/ can be prepared by passing chlorine ibrllocations.html. into a hot solution of lime (CaCO ) in (c) In accordance with § 184.1(b)(1), 3 which iodine has been dissolved. the ingredient is used in food with no (b) The ingredient meets the speci- limitation other than current good fications of the ‘‘Food Chemicals manufacturing practice. The affirma- Codex,’’ 3d Ed. (1981), p. 53, which is in- tion of this ingredient as generally rec- corporated by reference. Copies may be ognized as safe (GRAS) as a direct obtained from the National Academy human food ingredient is based upon Press, 2101 Constitution Ave. NW., the following current good manufac- Washington, DC 20418, or may be exam- turing practice conditions of use: ined at the National Archives and (1) The ingredient is used as a nutri- Records Administration (NARA). For ent supplement as defined in information on the availability of this § 170.3(o)(20) of this chapter. material at NARA, call 202–741–6030, or (2) The ingredient is used in gelatins, go to: http://www.archives.gov/ puddings, and fillings as defined in federallregister/ § 170.3(n)(22) of this chapter. codeloflfederallregulations/ (d) Prior sanctions for this ingredient ibrllocations.html. different from the uses established in (c) The ingredient is used as a dough this section or different from that as strengthener as defined in § 170.3(o)(6) set forth in part 181 of this chapter, do of this chapter. not exist or have been waived. (d) The ingredient is used in the man- [57 FR 10813, Mar. 31, 1992] ufacture of bread in accordance with § 184.1(b)(2) of this chapter in an § 184.1205 Calcium hydroxide. amount not to exceed 0.0075 percent based on the weight of the flour. (a) Calcium hydroxide (Ca(OH)2, CAS Reg. No. 1305–62–0) is also known as (e) Prior sanctions for this ingredient slaked lime or calcium hydrate. It is different from the uses established in produced by the hydration of lime. this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the Food Chemicals Codex, [43 FR 11699, Mar. 21, 1978, as amended at 49 3d Ed. (1981), p. 52, which is incor- FR 5611, Feb. 14, 1984] porated by reference. Copies are available from the National Academy Press, § 184.1207 Calcium lactate.

2101 Constitution Ave. NW., Wash- (a) Calcium lactate (C6H10CaO6.xH2O, ington, DC 20418, or available for in- where x is any integer up to 5, CAS spection at the National Archives and Reg. No. 814–80–2) is prepared commer- Records Administration (NARA). For cially by the neutralization of lactic information on the availability of this acid with calcium carbonate or cal- material at NARA, call 202–741–6030, or cium hydroxide. go to: http://www.archives.gov/ (b) The ingredient meets the speci- federallregister/ fications of the Food Chemicals Codex, codeloflfederallregulations/ 3d Ed. (1981), p. 53, which is incor- ibrllocations.html. porated by reference. Copies are avail- (c) In accordance with § 184.1(b)(1), able from the National Academy Press, the ingredient is used in food with no 2101 Constitution Avenue NW., Wash- limitation other than current good ington, DC 20418, or available for in- manufacturing practice. spection at the National Archives and (d) Prior sanctions for this ingredient Records Administration (NARA). For different from the uses established in information on the availability of this

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material at NARA, call 202–741–6030, or limitation other than current good go to: http://www.archives.gov/ manufacturing practice. federallregister/ (d) Prior sanctions for this ingredient codeloflfederallregulations/ different from the uses established in ibrllocations.html. this section do not exist or have been (c) In accordance with § 184.1(b)(1), waived. the ingredient is used in food with no limitation other than current good [49 FR 26714, June 29, 1984] manufacturing practice. The affirma- § 184.1212 Calcium pantothenate. tion of this ingredient as generally recognized as safe (GRAS) as a direct (a) Calcium pantothenate human food ingredient is based upon ((C9H16NO5)2Ca, CAS Reg. No. of the D- the following current good manufac- isomer, 137–08–6) is a salt of panto- turing practice conditions of use: thenic acid, one of the vitamins of the (1) The ingredient is used as a firm- B complex. Only the D-isomer of panto- ing agent as defined in § 170.3(o)(10) of thenic acid has vitamin activity, al- this chapter; a flavor enhancer as de- though both the D-isomer and the DL- fined in § 170.3(o)(11) of this chapter; a racemic mixture of calcium panto- flavoring agent or adjuvant as defined thenate are used in food. Commercial in § 170.3(o)(12) of this chapter; a leav- calcium pantothenate is prepared syn- ening agent as defined in § 170.3(o)(17) of thetically from isobutyraldehyde and this chapter; a nutrient supplement as formaldehyde via 1,1-dimethyl-2-hy- defined in § 170.3(o)(20) of this chapter; droxy-propionaldehyde and and a stabilizer and thickener as de- pantolactone. fined in § 170.3(o)(28) of this chapter. (b) Calcium pantothenate meets the (2) The ingredient is used in food, ex- specifications of the Food Chemicals cept in infant foods and infant for- Codex, 3d Ed. (1981), p. 56, which is in- mulas, at levels not to exceed current corporated by reference. Copies are good manufacturing practice. available from the National Academy (d) Prior sanctions for this ingredient Press, 2101 Constitution Ave. NW., different from the uses established in Washington, DC 20418, or available for this section do not exist or have been inspection at the National Archives waived. and Records Administration (NARA). [49 FR 35367, Sept. 7, 1984] For information on the availability of this material at NARA, call 202–741– § 184.1210 Calcium oxide. 6030, or go to: http://www.archives.gov/ (a) Calcium oxide (CaO, CAS Reg. No. federallregister/ 1305–78–8) is also known as lime, quick codeloflfederallregulations/ lime, burnt lime, or calx. It is produced ibrllocations.html. from calcium carbonate, limestone, or (c) In accordance with § 184.1(b)(1), oyster shells by calcination at tem- the ingredient is used in food with no peratures of 1,700–2,450 °F. limitation other than current good (b) The ingredient meets the speci- manufacturing practice. The affirma- fications of the Food Chemicals Codex, tion of this ingredient as generally rec- 3d Ed. (1981), p. 55, which is incor- ognized as safe (GRAS) as a direct porated by reference. Copies are avail- human food ingredient is based upon able from the National Academy Press, the following current good manufac- 2101 Constitution Ave. NW., Wash- turing practice conditions of use: ington, DC 20418, or available for in- (1) The ingredient is used as a nutri- spection at the National Archives and ent supplement as defined in Records Administration (NARA). For § 170.3(o)(20) of this chapter. information on the availability of this (2) The ingredient is used in foods at material at NARA, call 202–741–6030, or levels not to exceed current good man- go to: http://www.archives.gov/ ufacturing practice. Calcium panto- federallregister/ thenate may be used in infant formula codeloflfederallregulations/ in accordance with section 412(g) of the ibrllocations.html. Federal Food, Drug, and Cosmetic Act (c) In accordance with § 184.1(b)(1), (the act) or with regulations promul- the ingredient is used in food with no gated under section 412(a)(2) of the Act.

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(d) Prior sanctions for this ingredient § 184.1229 Calcium stearate. different from the uses established in (a) Calcium stearate (Ca(C17H35COO)2, this section do not exist or have been CAS Reg. No. 1529–23–0) is the calcium waived. salt of stearic acid derived from edible [48 FR 51908, Nov. 15, 1983] sources. It is prepared as a white precipitate by mixing calcium chloride § 184.1221 Calcium propionate. and sodium stearate in aqueous solu-

(a) Calcium propionate (C6H10CaO4, tion. CAS Reg. No. 4075–81–4) is the calcium (b) The ingredient meets the speci- salt of propionic acid. It occurs as fications of the Food Chemicals Codex, white crystals or a crystalline solid, 3d Ed. (1981), p. 64, which is incor- possessing not more than a faint odor porated by reference, and the require- of propionic acid. It is prepared by neu- ments of § 172.860(b)(2) of this chapter. tralizing propionic acid with calcium Copies of the Food Chemicals Codex hydroxide. are available from the National Acad- (b) The ingredient meets the speci- emy Press, 2101 Constitution Ave. NW., fications of the Food Chemicals Codex, Washington, DC 20418, or available for 3d Ed. (1981), p. 60, which is incor- inspection at the National Archives porated by reference. Copies are avail- and Records Administration (NARA). able from the National Academy Press, For information on the availability of 2101 Constitution Ave. NW., Wash- this material at NARA, call 202–741– ington, DC 20418, or available for in- 6030, or go to: http://www.archives.gov/ spection at the National Archives and federallregister/ Records Administration (NARA). For codeloflfederallregulations/ information on the availability of this ibrllocations.html. material at NARA, call 202–741–6030, or (c) In accordance with § 184.1(b)(1), go to: http://www.archives.gov/ the ingredient is used in food with no federallregister/ limitation other than current good codeloflfederallregulations/ manufacturing practice. The affirma- ibrllocations.html. tion of this ingredient as generally rec- (c) In accordance with § 184.1(b)(1), ognized as safe (GRAS) as a direct the ingredient is used in food with no human food ingredient is based upon limitation other than current good the following current good manufac- manufacturing practice. The affirma- turing practice conditions of use: tion of this ingredient as generally rec- (1) The ingredient is used as a fla- ognized as safe (GRAS) as a direct voring agent and adjuvant as defined in human food ingredient is based upon § 170.3(o)(12) of this chapter; a lubricant the following current good manufac- and release agent as defined in turing practice conditions of use: § 170.3(o)(18) of this chapter; and a sta- (1) The ingredient is used as an anti- bilizer and thickener as defined in microbial agent as defined in § 170.3(o)(28) of this chapter. § 170.3(o)(2) of this chapter. (2) The ingredient is used in foods at (2) The ingredient is used in the fol- levels not to exceed current good man- lowing foods at levels not to exceed ufacturing practice. current good manufacturing practice: (d) Prior sanctions for this ingredient baked goods as defined in § 170.3(n)(1) of different from the uses established in this chapter; cheeses as defined in this section do not exist or have been § 170.3(n)(5) of this chapter; confections waived. and frostings as defined in § 170.3(n)(9) [48 FR 52445, Nov. 18, 1983] of this chapter; gelatins, puddings, and fillings as defined in § 170.3(n)(22) of § 184.1230 Calcium sulfate. this chapter; and jams and jellies as de- (a) Calcium sulfate (CaSO , CAS Reg. fined in § 170.3(n)(28) of this chapter. 4 No. 7778–18–9 or CaSO4·2H2O, CAS Reg. (d) Prior sanctions for this ingredient No. 10101–41–4), also known as plaster of different from the uses established in Paris, anhydrite, and gypsum, occurs this section do not exist or have been naturally and exists as a fine, white to waived. slightly yellow-white odorless powder. [49 FR 13141, Apr. 3, 1984] The anhydrous form is prepared by

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complete dehydration of gypsum, below and 0.07 percent or less for all other 300 °C, in an electric oven. food categories. (b) The ingredient meets the speci- (e) Prior sanctions for this ingredient fications of the ‘‘Food Chemicals different from the uses established in Codex,’’ 3d Ed. (1981), p. 66, which is in- this section do not exist or have been corporated by reference. Copies may be waived. obtained from the National Academy [45 FR 6086, Jan. 25, 1980; 45 FR 26319, Apr. 18, Press, 2101 Constitution Ave. NW., 1980, as amended at 49 FR 5611, Feb. 14, 1984] Washington, DC 20418, or may be examined at the National Archives and § 184.1240 Carbon dioxide. Records Administration (NARA). For (a) Carbon dioxide (empirical formula information on the availability of this CO , CAS Reg. No. 124–38–9) occurs as a material at NARA, call 202–741–6030, or 2 colorless, odorless, noncombustible gas go to: http://www.archives.gov/ at normal temperatures and pressures. federallregister/ The solid form, dry ice, sublimes under codeloflfederallregulations/ atmospheric pressure at a temperature ibrllocations.html. of ¥78.5 °C. Carbon dioxide is prepared (c) The ingredient is used as an as a byproduct of the manufacture of anticaking agent as defined in lime during the ‘‘burning’’ of lime- § 170.3(o)(1) of this chapter, color and stone, from the combustion of carbo- coloring adjunct as defined in naceous material, from fermentation § 170.3(o)(4) of this chapter, dough processes, and from gases found in cer- strengthener as defined in § 170.3(o)(6) tain natural springs and wells. of this chapter, drying agent as defined (b) The ingredient must be of a pu- in § 170.3(o)(7) of this chapter, firming rity suitable for its intended use. agent as defined in § 170.3(o)(10) of this (c) In accordance with § 184.1(b)(1), chapter, flour treating agent as defined the ingredient is used in food with no in § 170.3(o)(13) of this chapter, formula- limitations other than current good tion aid as defined in § 170.3(o)(14) of manufacturing practice. The affirma- this chapter, leavening agent as de- tion of this ingredient as generally rec- fined in § 170.3(o)(17) of this chapter, nu- ognized as safe (GRAS) as a direct trient supplement as defined in human food ingredient is based upon § 170.3(o)(20) of this chapter, pH control the following current good manufac- agent as defined in § 170.3(o)(23) of this turing practice conditions of use: chapter, processing aid as defined in (1) The ingredient is used as a leav- § 170.3(o)(24) of this chapter, stabilizer ening agent as defined in § 170.3(o)(17) of and thickener as defined in § 170.3(o)(28) this chapter; a processing aid as de- of this chapter, synergist as defined in fined in § 170.3(o)(24) of this chapter; § 170.3(o)(31) of this chapter, and and a propellant, aerating agent, and texturizer as defined in § 170.3(o)(32) of gas as defined in § 170.3(o)(25) of this this chapter. chapter. (d) The ingredient is used in food at (2) The ingredient is used in food at levels not to exceed good manufac- levels not to exceed current good man- turing practice in accordance with ufacturing practice. § 184.1(b)(1). Current good manufac- (d) Prior sanctions for this ingredient turing practice results in a maximum different from the uses established in level, as served, of 1.3 percent for baked this section do not exist or have been goods as defined in § 170.3(n)(1) of this waived. chapter, 3.0 percent for confections and frostings as defined in § 170.3(n)(9) of [48 FR 57270, Dec. 29, 1983, as amended at 73 this chapter, 0.5 percent for frozen FR 8607, Feb. 14, 2008] dairy desserts and mixes as defined in § 170.3(n)(20) of this chapter, 0.4 percent § 184.1245 Beta-carotene. for gelatins and puddings as defined in (a) Beta-carotene (CAS Reg. No. 7235– § 170.3(n)(22) of this chapter, 0.5 percent 40–7) has the molecular formula C40H56. for grain products and pastas as de- It is synthesized by saponification of fined in § 170.3(n)(23) of this chapter, vitamin A acetate. The resulting alco- 0.35 percent for processed vegetables as hol is either reacted to form vitamin A defined in § 170.3(n)(36) of this chapter, Wittig reagent or oxidized to vitamin A

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aldehyde. Vitamin A Wittig reagent linkages in cellulose. It is obtained and vitamin A aldehyde are reacted to- from the culture filtrate resulting from gether to form beta-carotene. a pure culture fermentation process. (b) The ingredient meets the speci- (b) The ingredient meets the general fications of the Food Chemicals Codex, and additional requirements for en- 3d Ed. (1981), p. 73, which is incor- zyme preparations in the monograph porated by reference. Copies are avail- specifications on enzyme preparations able from the National Academy Press, in the ‘‘Food Chemicals Codex,’’ 4th ed. 2101 Constitution Ave. NW., (1996), pp. 129 to 134, which is incor- Washingtion, DC 20418, or available for porated by reference in accordance inspection at the National Archives with 5 U.S.C. 552(a) and 1 CFR part 51. and Records Administration (NARA). Copies are available from the National For information on the availability of Academy Press, 2101 Constitution Ave. this material at NARA, call 202–741– NW., Box 285, Washington, DC 20055 6030, or go to: http://www.archives.gov/ (Internet http://www.nap.edu), or may federallregister/ be examined at the Center for Food codeloflfederallregulations/ ibrllocations.html. Safety and Applied Nutrition’s Li- (c) In accordance with § 184.1(b)(1), brary, 5100 Paint Branch Pkwy., Col- the ingredient is used in food with no lege Park, MD 20740, or at the National limitation other than current good Archives and Records Administration manufacturing practice. The affirma- (NARA). For information on the avail- tion of this ingredient as generally rec- ability of this material at NARA, call ognized as safe (GRAS) as a direct 202–741–6030, or go to: http:// human food ingredient is based upon www.archives.gov/federallregister/ the following current good manufac- codeloflfederallregulations/ turing practice conditions of use: ibrllocations.html. (1) The ingredient is used as a nutri- (c) In accordance with § 184.1(b)(1), ent supplement as defined in the ingredient is used in food with no § 170.3(o)(20) of this chapter. limitation other than current good (2) The ingredient is used in the fol- manufacturing practice. The affirma- lowing foods at levels not to exceed tion of this ingredient as generally rec- current good manufacturing practice: ognized as safe (GRAS) as a direct dairy product analogs as defined in human food ingredient is based upon § 170.3(n)(10) of this chapter; fats and the following current good manufac- oils as defined in § 170.3(n)(12) of this turing practice conditions of use: chapter; and processed fruits and fruit (1) The ingredient is used in food as juices as defined in § 170.3(n)(35) of this an enzyme as defined in § 170.3(o)(9) of chapter. Beta-carotene may be used in this chapter for the breakdown of cel- infant formula as a source of vitamin A lulose. in accordance with section 412(g) of the (2) The ingredient is used in food at Federal Food, Drug, and Cosmetic Act levels not to exceed current good man- or with regulations promulgated under ufacturing practice. section 412(g) of the act. (d) Prior sanctions for this ingredient [64 FR 28361, May 26, 1999] different from the uses established in this section do not exist or have been § 184.1257 Clove and its derivatives. waived. (a) Cloves are the dried unopened [52 FR 25211, July 6, 1987] flower buds and calyx tubes, harvested before the flowers have opened, of the § 184.1250 Cellulase enzyme prepara- clove tree Eugenia caryophyllata tion derived from Trichoderma Thunberg, native to tropical Asia. longibrachiatum. Their derivatives include essential oils (a) Cellulase enzyme preparation is (cloves, CAS Reg. No. 8000–34–8; buds; derived from a nonpathogenic, leaves, CAS Reg. No. 8015–97–2; stems, nontoxicogenic strain of Trichoderma CAS Reg. No. 8015–98–3; and eugenol, longibrachiatum (formerly T. reesei). The CAS Reg. No. 97–53–0), oleoresins, and enzyme, cellulase, catalyzes the natural extractives obtained from endohydrolysis of 1,4-beta-glycosidic clove buds, leaves, and stems.

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(b) Clove bud oil, clove leaf oil, clove in this section do not exist or have stem oil, and eugenol meet the speci- been waived. fications of the ‘‘Food Chemicals [44 FR 3964, Jan 19, 1979, as amended at 47 FR Codex,’’ 4th ed. (1996), pp. 104–105, which 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, 1984; is incorporated by reference in accord- 64 FR 1759, Jan. 12, 1999] ance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the § 184.1259 Cocoa butter substitute. National Academy Press, Box 285, 2101 (a) The common or usual name for Constitution Ave. NW., Washington, the triglyceride 1-palmitoyl-2-oleoyl-3- DC 20055 (Internet address http:// stearin is ‘‘cocoa butter substitute pri- www.nap.edu), or may be examined at marily from palm oil.’’ The common or the Center for Food Safety and Applied usual name for the triglyceride 1-3- Nutrition’s Library, Food and Drug Ad- distearoyl-2-olein is ‘‘cocoa butter sub- ministration, 5100 Paint Branch Pkwy., stitute primarily from high-oleic saf- College Park, MD 20740, or at the Na- flower or sunflower oil.’’ tional Archives and Records Adminis- (1) The ingredient 1-palmitoyl-2-ole- tration (NARA). For information on oyl-3-stearin is manufactured by: the availability of this material at (i) Directed esterification of fully NARA, call 202–741–6030, or go to: http:// saturated 1,3-diglycerides (derived from www.archives.gov/federallregister/ palm oil) with the anhydride of food- codeloflfederallregulations/ grade oleic acid in the presence of the ibrllocations.html. As determined by catalyst trifluoromethane sulfonic acid analytical methods in the ‘‘Food (§ 173.395 of this chapter), or Chemicals Codex,’’ clove oleoresin or (ii) By interesterification of partially other natural extractives (other than saturated 1,2,3-triglycerides (derived clove oils) meet the ‘‘Food Chemicals from palm oil) with ethyl stearate in Codex’’ specifications for clove (clove the presence of a suitable lipase enzyme preparation that is either gen- bud) oil and the following modifica- erally recognized as safe (GRAS) or has tions: food additive approval for such use. (1) The assay for phenols, as eugenol, (2) The ingredient 1-3-distearoyl-2- by the ‘‘Food Chemicals Codex’’ test, olein is manufactured by 4th ed. (pp. 104–105), or the volatile oils interesterification of partially unsatu- content by the ‘‘Food Chemicals rated 1,2,3-triglycerides (derived from Codex’’ test, 4th ed. (pp. 104–105) should high-oleic safflower or sunflower oil) conform to the representation of the with ethyl stearate or stearic acid in vendor; the presence of a suitable lipase en- (2) Optical rotation of the volatile oil zyme preparation that is either GRAS between ¥2° and 0°; or has food additive approval for such (3) Refractive index of the volatile oil use. between 1.527 and 1.538 at 20 °C; (b) The ingredient meets the fol- (4) Specific gravity of the volatile oil lowing specifications: between 1.036 and 1.060; and (1) Over 90 percent triglycerides, not (5) Residual solvent free, except those more than 7 percent diglycerides, not solvents that are GRAS or within tol- more than 1 percent monoglycerides, erance levels as specified in part 173, and not more than 1 percent free fatty subpart C, of this chapter. acids. (c) Clove and its derivatives are used (2) Total glycerides—98 percent min- as flavoring agents and adjuvants as imum. defined in § 170.3(0)(12) of this chapter. (3) Heavy metals (as lead), not more than 10 milligrams per kilogram, as de- (d) The ingredients are used in food termined by the Heavy Metals Test of at levels not to exceed good manufac- the ‘‘Food Chemicals Codex,’’ 4th ed. turing practice in accordance with (1996), pp. 760–761, which is incorporated § 184.1(b)(1). by reference in accordance with 5 (e) Prior sanctions for these ingredi- U.S.C. 552(a) and 1 CFR part 51. Copies ents different from the uses established are available from the National Acad- emy Press, Box 285, 2101 Constitution

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Ave. NW., Washington, DC 20055 (Inter- information on the availability of this net address http://www.nap.edu), or may material at NARA, call 202–741–6030, or be examined at the Center for Food go to: http://www.archives.gov/ Safety and Applied Nutrition’s Li- federallregister/ brary, Food and Drug Administration, codeloflfederallregulations/ 5100 Paint Branch Pkwy., College Park, ibrllocations.html. MD 20740, or at the National Archives (9) Hexane—not more than 5 parts per and Records Administration (NARA). million as determined by the method of For information on the availability of Dupuy et al., ‘‘Rapid Quantitative De- this material at NARA, call 202–741– termination of Residual Hexane in Oils 6030, or go to: http://www.archives.gov/ by Direct Gas Chromatography,’’ pub- federallregister/ lished in the ‘‘Journal of the American code of federal regulations/ l l l Oil Chemists’ Society,’’ Vol. 52, p. 118– ibrllocations.html. 120, 1975, which is incorporated by ref- (4) Color—clear, bright, and free from erence. Copies are available from the suspended matter. (5) Odor and taste—free from foreign Division of Food and Color Additives, and rancid odor and taste. Center for Food Safety and Applied Nu- (6) Residual catalyst (‘‘Official Meth- trition (HFS–200), Food and Drug Ad- ods of Analysis of the Association of ministration, 5100 Paint Branch Pkwy., Official Analytical Chemists,’’ 13th Ed. College Park, MD 20740, or available for (1980), sections 25.049–25.055, which is inspection at the National Archives incorporated by reference), residual and Records Administration (NARA). fluorine; limit of detection 0.2 part per For information on the availability of million F; multiply fluoride result by this material at NARA, call 202–741– 2.63 to convert to residual catalyst. 6030, or go to: http://www.archives.gov/ Copies of the material incorporated by federallregister/ reference may be obtained from the codeloflfederallregulations/ AOAC INTERNATIONAL, 481 North ibrllocations.html. Frederick Ave., suite 500, Gaithersburg, (c) In accordance with § 184.1(b)(1), MD 20877, or may be examined at the the ingredient is used in the following National Archives and Records Admin- food categories at levels not to exceed istration (NARA). For information on current good manufacturing practice: the availability of this material at Confections and frostings as defined in NARA, call 202–741–6030, or go to: http:// § 170.3(n)(9) of this chapter; coatings of www.archives.gov/federallregister/ soft candy as defined in § 170.3(n)(38) of codeloflfederallregulations/ this chapter; and sweet sauces and top- ibrllocations.html. The ingredient shall pings as defined in § 170.3(n)(43) of this be washed three times in batches with chapter; except that the ingredient 0.5 percent sodium bicarbonate to re- may not be used in a standardized food move catalyst residuals in accordance unless permitted by the standard of with good manufacturing practice. identity. (7) Residual methanol—5 parts per (d) The ingredient is used in food in million maximum. accordance with § 184.1(b)(1) at levels (8) Residual fatty acid ethyl esters— not to exceed good manufacturing not more than 20 parts per million as practice. determined by a ‘‘Modification of Japan Institute of Oils and Fats: Anal- [43 FR 54239, Nov. 11, 1978, as amended at 47 ysis Method of Residual Ethyl Esters of FR 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, Fatty Acids’’ issued by the Fuji Oil 1984; 49 FR 22799, June 1, 1984; 52 FR 47920, Co., which is incorporated by reference. Dec. 17, 1987; 52 FR 48905, Dec. 28, 1987; 61 FR Copies are available from the Division 36290, July 10, 1996; 64 FR 1760, Jan. 12, 1999] of Food and Color Additives, Center for § 184.1260 Copper gluconate. Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra- (a) Copper gluconate (cupric gluco- tion, 5100 Paint Branch Pkwy., College nate (CH2OH(CHOH)4COO)2Cu, CAS Park, MD 20740, or available for inspec- Reg. No. 527–09–3) is a substance that tion at the National Archives and occurs as light blue to bluish-green, Records Administration (NARA). For odorless crystals, or as a fine, light

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blue powder. It is prepared by the reac- (c) In accordance with § 184.1(b)(1), tion of gluconic acid solutions with cu- the ingredient is used in food with no pric oxide or basic cupric carbonate. limitation other than current good (b) The ingredient meets the speci- manufacturing practice. The affirma- fications of the Food Chemicals Codex, tion of this ingredient as generally rec- 3d Ed. (1981), p. 90, which is incor- ognized as safe (GRAS) as a direct porated by reference. Copies are avail- human food ingredient is based upon able from the National Academy Press, the following current good manufac- 2101 Constitution Ave. NW., Wash- turing practice conditions of use: ington, DC. 20418, or available for in- (1) The ingredient is used as a nutri- spection at the National Archives and ent supplement as defined in Records Administration (NARA). For § 170.3(o)(20) of this chapter and as a information on the availability of this processing aid as defined in § 170.3(o)(24) material at NARA, call 202–741–6030, or of this chapter. go to: http://www.archives.gov/ (2) The ingredient is used in food at federallregister/ levels not to exceed current good man- codeloflfederallregulations/ ufacturing practice. Copper sulfate ibrllocations.html. may be used in infant formula in ac- (c) In accordance with § 184.1(b)(1), cordance with section 412(g) of the Fed- the ingredient is used in food with no eral Food, Drug, and Cosmetic Act (the limitation other than current good Act) or with regulations promulgated manufacturing practice. The affirma- under section 412(a)(2) of the Act. tion of this ingredient as generally rec- (d) Prior sanctions for this ingredient ognized as safe (GRAS) as a direct different from the uses established in human food ingredient is based upon this section do not exist or have been the following current good manufac- waived. turing practice conditions of use: [49 FR 24119, June 12, 1984, as amended at 73 (1) The ingredient is used as a nutri- FR 8607, Feb. 14, 2008] ent supplement as defined in § 170.3(o)(20) of this chapter and as a § 184.1262 Corn silk and corn silk ex- synergist as defined in § 170.3(o)(31) of tract. this chapter. (a) Corn silk is the fresh styles and (2) The ingredient is used in food at stigmas of Zea mays L. collected when levels not to exceed current good man- the corn is in milk. The filaments are ufacturing practice. Copper gluconate extracted with dilute ethanol to may be used in infant formula in ac- produce corn silk extract. The extract cordance with section 412(g) of the Fed- may be concentrated at a temperature eral Food, Drug, and Cosmetic Act (the not exceeding 60 °C. Act) or with regulations promulgated (b) The ingredient must be of a pu- under section 412(a)(2) of the Act. rity suitable for its intended use. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(2), different from the uses established in the ingredients are used in food only this section do not exist or have been within the following specific limita- waived. tions: [49 FR 24119, June 12, 1984] Maximum level of Category of food use in Functional use § 184.1261 Copper sulfate. food (as served) 1 (a) Copper sulfate (cupric sulfate, Baked goods and bak- 30 Flavoring agent, CuSO4·5H2O, CAS Reg. No. 7758–98–7) ing mixes, § 170.3(o)(12) of this usually is used in the pentahydrate § 170.3(n)(1) of this chapter. form. This form occurs as large, deep chapter. blue or ultramarine, triclinic crystals; Nonalcoholic bev- 20 Do. as blue granules, or as a light blue pow- erages, § 170.3(n)(3) of this chapter. der. The ingredient is prepared by the Frozen dairy desserts, 10 Do. reaction of sulfuric acid with cupric § 170.3(n)(20) of this oxide or with copper metal. chapter. Soft candy, 20 Do. (b) The ingredient must be of a pu- § 170.3(n)(38) of this rity suitable for its intended use. chapter.

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Maximum codeloflfederallregulations/ level of ibr locations.html. Category of food use in Functional use l food (as (c) The ingredient is used to supply served) 1 up to 0.009 part of total L-cysteine per All other food cat- 4 Do. 100 parts of flour in dough as a dough egories. strengthener as defined in § 170.3(o)(6) 1 Parts per million. of this chapter in yeast-leavened baked goods and baking mixes as defined in (d) Prior sanctions for this ingredient § 170.3(n)(1) of this chapter. different from the uses established in (d) This regulation is issued prior to this section do not exist or have been a general evaluation of use of this in- waived. gredient in order to affirm as GRAS [47 FR 29953, July 9, 1982, as amended at 73 the specific use named. FR 8607, Feb. 14, 2008] [42 FR 14653, Mar. 15, 1977, as amended at 49 § 184.1265 Cuprous iodide. FR 5612, Feb. 14, 1984] (a) Cuprous iodide (copper (I) iodide, § 184.1272 L-Cysteine CuI, CAS Reg. No. 7681–65–4) is a pure monohydrochloride. white crystalline powder. It is prepared by the reaction of copper sulfate with (a) L-Cysteine monohydrochloride is potassium iodide under slightly acidic the chemical L-2-amino-3- conditions. mercaptopropanoic acid (b) The ingredient must be of a pu- monohydrochloride monohydrate rity suitable for its intended use. (C3H7O2NS HCl H2O). (c) In accordance with § 184.1(b)(2), (b) The ingredient meets the speci- the ingredient is used in food only fications of the ‘‘Food Chemicals within the following specific limita- Codex,’’ 3d Ed. (1981), pp. 92–93, which is tions: incorporated by reference. Copies may be obtained from the National Acad- Cat- emy Press, 2101 Constitution Ave. NW., egory Maximum treatment Functional use of food level in food Washington, DC 20418, or may be examined at the National Archives and Table 0.01 percent ...... Source of dietary iodine. Records Administration (NARA). For salt. information on the availability of this (d) Prior sanctions for this ingredient material at NARA, call 202–741–6030, or different from the uses established in go to: http://www.archives.gov/ this section do not exist or have been federallregister/ waived. codeloflfederallregulations/ ibrllocations.html. [49 FR 24119, June 12, 1984, as amended at 73 (c) The ingredient is used to supply FR 8607, Feb. 14, 2008] up to 0.009 part of total L-cysteine per § 184.1271 L-Cysteine. 100 parts of flour in dough as a dough strengthener as defined in § 170.3(o)(6) (a) L-Cysteine is the chemical L-2- of this chapter in yeast-leavened baked amino-3-mercaptopropanoic acid goods and baking mixes as defined in (C3H7O2NS). § 170.3(n)(1) of this chapter. (b) The ingredient meets the appro- (d) This regulation is issued prior to priate part of the specification set a general evaluation of use of this in- forth in the ‘‘Food Chemicals Codex,’’ gredient in order to affirm as GRAS 3d Ed. (1981), pp. 92–93, which is incor- the specific use named. porated by reference. Copies may be obtained from the National Academy [42 FR 14653, Mar. 15, 1977, as amended at 49 Press, 2101 Constitution Ave. NW., FR 5612, Feb. 14, 1984] Washington, DC 20418, or may be examined at the National Archives and § 184.1277 Dextrin. Records Administration (NARA). For (a) Dextrin ((C6H10O5)n·H2O, CAS Reg. information on the availability of this No. 9004–53–9) is an incompletely material at NARA, call 202–741–6030, or hydrolyzed starch. It is prepared by dry go to: http://www.archives.gov/ heating corn, waxy maize, waxy milo, federallregister/ potato, arrowroot, wheat, rice, tapioca,

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or sago starches, or by dry heating the 3d Ed. (1981), p. 368, which is incor- starches after: (1) Treatment with safe porated by reference. Copies are avail- and suitable alkalis, acids, or pH con- able from the National Academy Press, trol agents and (2) drying the acid or 2101 Constitution Ave. NW., Wash- alkali treated starch. ington, DC 20418, or available for in- (b) The ingredient meets the speci- spection at the National Archives and fication of the Food Chemicals Codex, Records Administration (NARA). For 3d Ed. (1981), p. 96, which is incor- information on the availability of this porated by reference. Copies are avail- material at NARA, call 202–741–6030, or able from the National Academy Press, go to: http://www.archives.gov/ 2101 Constitution Ave. NW., Wash- federallregister/ ington, DC 20418, or available for in- codeloflfederallregulations/ spection at the National Archives and ibrllocations.html. Records Administration (NARA). For (c) In accordance with § 184.1(b)(1), information on the availability of this the ingredient is used in food with no material at NARA, call 202–741–6030, or limitation other than current good go to: http://www.archives.gov/ manufacturing practice. The affirma- federallregister/ tion of this ingredient as generally rec- codeloflfederallregulations/ ognized as safe (GRAS) as a direct ibrllocations.html. human food ingredient is based upon (c) In accordance with § 184.1(b)(1), the following current good manufac- the ingredient is used in food with no turing practice conditions of use: limitation other than current good (1) The ingredient is used as a fla- manufacturing practice. The affirma- voring agent and adjuvant as defined in tion of this ingredient as generally rec- § 170.3(o)(12) of this chapter. ognized as safe (GRAS) as a direct (2) The ingredient is used in food at human food ingredient is based upon levels not to exceed current good man- the following current good manufac- ufacturing practice. turing practice conditions of use: (d) Prior sanctions for this ingredient (1) The ingredient is used as a formu- different from the uses established in lation aid as defined in § 170.3(o)(14) of this section do not exist or have been this chapter; as a processing aid as de- waived. fined in § 170.3(o)(24) of this chapter; as [48 FR 51907, Nov. 15, 1983] a stabilizer and thickener as defined in § 170.3(o)(28) of this chapter; and as a § 184.1282 Dill and its derivatives. surface-finishing agent as defined in (a) Dill (American or European) is § 170.3(o)(30) of this chapter. the herb and seeds from Anethum (2) The ingredient is used in food at graveolens L., and dill (Indian) is the levels not to exceed current good man- herb and seeds from Anethum sowa, ufacturing practice. D.C. Its derivatives include essential (d) Prior sanctions for this ingredient oils, oleoresins, and natural extractives different from the uses established in obtained from these sources of dill. this section do not exist or have been (b) Dill oils meet the description and waived. specifications of the ‘‘Food Chemicals [48 FR 51909, Nov. 15, 1983] Codex,’’ 4th ed. (1996), pp. 122–123, which is incorporated by reference in accord- § 184.1278 Diacetyl. ance with 5 U.S.C. 552(a) and 1 CFR (a) Diacetyl (C4H6O2, CAS Reg. No. part 51. Copies are available from the 431–03–8) is a clear yellow to yellowish National Academy Press, Box 285, 2101 green liquid with a strong pungent Constitution Ave. NW., Washington, odor. It is also known as 2,3- DC 20055 (Internet address http:// butanedione and is chemically syn- www.nap.edu), or may be examined at thesized from methyl ethyl ketone. It the Center for Food Safety and Applied is miscible in water, glycerin, alcohol, Nutrition’s Library, Food and Drug Ad- and ether, and in very dilute water so- ministration, 5100 Paint Branch Pkwy., lution, it has a typical buttery odor College Park, MD 20740, or at the Na- and flavor. tional Archives and Records Adminis- (b) The ingredient meets the speci- tration (NARA). For information on fications of the Food Chemicals Codex, the availability of this material at

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NARA, call 202–741–6030, or go to: http:// in this section do not exist or have www.archives.gov/federallregister/ been waived. codeloflfederallregulations/ [52 FR 25976, July 10, 1987, as amended at 73 ibrllocations.html. FR 8607, Feb. 14, 2008] (c) Dill and its derivatives are used as flavoring agents and adjuvants as de- § 184.1293 Ethyl alcohol. fined in § 170.3(o)(12) of this chapter. (d) The ingredients are used in food (a) Ethyl alcohol (ethanol) is the at levels not to exceed good manufac- chemical C2H5OH. turing practice. (b) The ingredient meets the speci- (e) [Reserved] fications of the ‘‘Food Chemicals (f) Prior sanctions for these ingredi- Codex,’’ 4th ed. (1996), p. 136, which is ents different from the uses established incorporated by reference in accord- in this section do not exist or have ance with 5 U.S.C. 552(a) and 1 CFR been waived. part 51. Copies are available from the National Academy Press, Box 285, 2101 [42 FR 14653, Mar. 15, 1977, as amended at 42 Constitution Ave. NW., Washington, FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, DC 20055 (Internet address http:// 1984; 64 FR 1760, Jan. 12, 1999] www.nap.edu), or may be examined at § 184.1287 Enzyme-modified fats. the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Ad- (a) Enzyme-modified refined beef fat, ministration, 5100 Paint Branch Pkwy., enzyme-modified butterfat, and en- College Park, MD 20740, or at the Na- zyme-modified steam-rendered chicken tional Archives and Records Adminis- fat are prepared from refined beef fat; tration (NARA). For information on butterfat or milkfat; and steam-ren- the availability of this material at dered chicken fat, respectively, with NARA, call 202–741–6030, or go to: http:// enzymes that are generally recognized www.archives.gov/federallregister/ as safe (GRAS). Enzyme-modified milk codeloflfederallregulations/ powder may be prepared with GRAS ibrllocations.html. enzymes from reconstituted milk pow- (c) The ingredient is used as an anti- der, whole milk, condensed or con- microbial agent as defined in centrated whole milk, evaporated § 170.3(o)(2) of this chapter on pizza milk, or milk powder. The lipolysis is crusts prior to final baking at levels maintained at a temperature that is not to exceed 2.0 percent by product optimal for the action of the enzyme weight. until appropriate acid development is attained. The enzymes are then inac- (d) This regulation is issued prior to tivated. The resulting product is con- general evaluation of use of this ingre- centrated or dried. dient in order to affirm as GRAS the specific use named. (b) The ingredients must be of a purity suitable for their intended use. [42 FR 14653, Mar. 15, 1977, as amended at 49 (c) In accordance with § 184.1(b)(1), FR 5612, Feb. 14, 1984; 64 FR 1760, Jan. 12, the ingredients are used in food with 1999] no limitation other than current good manufacturing practice. The affirma- § 184.1295 Ethyl formate.

tion of these ingredients as generally (a) Ethyl formate (C3H6O2, CAS Reg. recognized as safe (GRAS) as direct No. 109–94–4) is also referred to as ethyl human food ingredients is based upon methanoate. It is an ester of formic the following current good manufac- acid and is prepared by esterification turing practice conditions of use: of formic acid with ethyl alcohol or by (1) The ingredients are used as fla- distillation of ethyl acetate and formic voring agents and adjuvants as defined acid in the presence of concentrated in § 170.3(o)(12) of this chapter. sulfuric acid. Ethyl formate occurs (2) The ingredients are used in food naturally in some plant oils, fruits, and at levels not to exceed current good juices but does not occur naturally in manufacturing practice. the animal kingdom. (d) Prior sanctions for these ingredi- (b) The ingredient meets the speci- ents different from the uses established fications of the ‘‘Food Chemicals

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Codex,’’ 3d Ed. (1981), p. 376, which is in- (2) Ferric ammonium citrate (iron corporated by reference. Copies may be (III) ammonium citrate, CAS Reg. No. obtained from the National Academy 1333–00–2) is a complex salt of undeter- Press, 2101 Constitution Ave. NW., mined structure composed of 14.5 to 16 Washington, DC 20418, or may be exam- percent iron, approximately 7.5 percent ined at the National Archives and ammonia, and 75 percent citric acid Records Administration (NARA). For and occurs as thin transparent green information on the availability of this scales, as granules, as a powder, or as material at NARA, call 202–741–6030, or transparent green crystals. go to: http://www.archives.gov/ (b) The ingredients meet the speci- federallregister/ fications of the Food Chemicals Codex, codeloflfederallregulations/ 3d Ed. (1981), pp. 116–117 (Ferric ammo- ibrllocations.html. nium citrate, brown) and p. 117 (Ferric (c) The ingredient is used as a fla- ammonium citrate, green), which is in- voring agent and adjuvant as defined in corporated by reference. Copies are § 170.3(o)(12) of this chapter. available from the National Academy (d) The ingredient is used in food at Press, 2101 Constitution Ave. NW., levels not to exceed good manufac- Washington, DC 20418, or available for turing practice in accordance with inspection at the National Archives § 184.1(b)(1). Current good manufac- and Records Administration (NARA). turing practice results in a maximum For information on the availability of level, as served, of 0.05 percent in baked this material at NARA, call 202–741– goods as defined in § 170.3(n)(1) of this 6030, or go to: http://www.archives.gov/ chapter; 0.04 percent in chewing gum as federallregister/ defined in § 170.3(n)(6), hard candy as codeloflfederallregulations/ defined in § 170.3(n)(25), and soft candy ibrllocations.html. as defined in § 170.3(n)(38) of this chap- (c) In accordance with § 184.1(b)(1), ter; 0.02 percent in frozen dairy des- the ingredients are used in food as nu- serts as defined in § 170.3(n)(20) of this trient supplements as defined in chapter; 0.03 percent in gelatins, pud- § 170.3(o)(20) of this chapter, with no dings, and fillings as defined in limitation other than current good § 170.3(n)(22) of this chapter; and 0.01 manufacturing practice. The ingredi- percent in all other food categories. ents may also be used in infant formula (e) Prior sanctions for ethyl formate in accordance with section 412(g) of the different from the uses established in Federal Food, Drug, and Cosmetic Act this section do not exist or have been (the act) (21 U.S.C. 350a(g)) or with reg- waived. ulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). [45 FR 22915, Apr. 4, 1980, as amended at 49 (d) Prior sanctions for these ingredi- FR 5612, Feb. 14, 1984] ents different from the uses established § 184.1296 Ferric ammonium citrate. in this section do not exist or have been waived. (a) Ferric ammonium citrate (iron (III) ammonium citrate) is prepared by [53 FR 16864, May 12, 1988] the reaction of ferric hydroxide with citric acid, followed by treatment with § 184.1297 Ferric chloride. ammonium hydroxide, evaporating, (a) Ferric chloride (iron (III) chlo- and drying. The resulting product oc- ride, FeC13, CAS Reg. No. 7705–08–0) curs in two forms depending on the may be prepared from iron and chlorine stoichiometry of the initial reactants. or from ferric oxide and hydrogen chlo- (1) Ferric ammonium citrate (iron ride. The pure material occurs as (III) ammonium citrate, CAS Reg. No. hydroscopic, hexagonal, dark crystals. 1332–98–5) is a complex salt of undeter- Ferric chloride hexahydrate (iron (III) mined structure composed of 16.5 to chloride hexahydrate, FeC13. 6H20, CAS 18.5 percent iron, approximately 9 per- Reg. No. 10025–77–1) is readily formed cent ammonia, and 65 percent citric when ferric chloride is exposed to mois- acid and occurs as reddish brown or ture. garnet red scales or granules or as a (b) The ingredient must be of a pu- brownish-yellowish powder. rity suitable for its intended use.

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(c) In accordance with § 184.1(b)(1) the spection at the National Archives and ingredient is used in food as a flavoring Records Administration (NARA). For agent as defined in § 170.3(o)(12) of this information on the availability of this chapter, with no limitation other than material at NARA, call 202–741–6030, or current good manufacturing practice. go to: http://www.archives.gov/ (d) Prior sanctions for this ingredient federallregister/ different from the uses established in codeloflfederallregulations/ this section do not exist or have been ibrllocations.html. waived. (c) In accordance with § 184.1(b)(1), the ingredient is used in food as nutri- [53 FR 16864, May 12, 1988, as amended at 73 ent supplement as defined in FR 8607, Feb. 14, 2008] § 170.3(o)(20) of this chapter, with no § 184.1298 Ferric citrate. limitation other than current good manufacturing practice. The ingre- (a) Ferric citrate (iron (III) citrate, dient may also be used in infant for- C6H5FeO7, CAS Reg. No. 2338–05–8) is mula in accordance with section 412(g) prepared from reaction of citric acid of the Federal Food, Drug, and Cos- with ferric hydroxide. It is a compound metic Act (the act) (21 U.S.C. 350a(g)) of indefinite ratio of citric acid and or with regulations promulgated under iron. section 412(a)(2) of the act (21 U.S.C. (b) The ingredient must be of a pu- 350a(a)(2)). rity suitable for its intended use. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the uses established in the ingredient is used in food as a nu- this section do not exist or have been trient supplement as defined in waived. § 170.3(o)(20) of this chapter, with no limitation other than current good [53 FR 16865, May 12, 1988] manufacturing practice. The ingre- § 184.1304 Ferric pyrophosphate. dient may also be used in infant formula in accordance with section 412(g) (a) Ferric pyrophosphate (iron (III) of the Federal Food, Drug, and Cos- pyrophosphate, Fe4(P207)3·xH2O, CAS metic Act (the act) (21 U.S.C. 350a(g)) Reg. No. 10058–44–3) is a tan or yel- or with regulations promulgated under lowish white colorless powder. It is pre- section 412(a)(2) of the act (21 U.S.C. pared by reacting sodium 350a(a)(2)). pyrophosphate with ferric citrate. (d) Prior sanctions for this ingredient (b) The ingredient meets the speci- different from the uses established in fications of the Food Chemicals Codex, this section do not exist or have been 3d Ed. (1981), p. 120, which is incor- waived. porated by reference. Copies are available from the National Academy Press, [53 FR 16865, May 12, 1988, as amended at 73 2101 Constitution Ave. NW., Wash- FR 8607, Feb. 14, 2008] ington, DC 20418, or available for inspection at the National Archives and § 184.1301 Ferric phosphate. Records Administration (NARA). For (a) Ferric phosphate (ferric information on the availability of this orthophosphate, iron (III) phosphate, material at NARA, call 202–741–6030, or FePO4·xH2O, CAS Reg. No. 10045–86–0) is go to: http://www.archives.gov/ an odorless, yellowish-white to buff- federallregister/ colored powder and contains from one codeloflfederallregulations/ to four molecules of water of hydra- ibrllocations.html. tion. It is prepared by reaction of so- (c) In accordance with § 184.1(b)(1), dium phosphate with ferric chloride or the ingredient is used in food as a nu- ferric citrate. trient supplement as defined in (b) The ingredient meets the speci- § 170.3(o)(20) of this chapter, with no fications of the Food Chemicals Codex, limitation other than current good 3d Ed. (1981), pp. 118–120, which is incor- manufacturing practice. The ingre- porated by reference. Copies are avail- dient may also be used in infant for- able from the National Academy Press, mula in accordance with section 412(g) 2101 Constitution Ave. NW., Wash- of the Federal Food, Drug, and Cos- ington, DC 20418, or available for in- metic Act (the act) (21 U.S.C. 350a(g))

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or with regulations promulgated under this section do not exist or have been section 412(a)(2) of the act (21 U.S.C. waived. 350a(a)(2)). [53 FR 16865, May 12, 1988, as amended at 69 (d) Prior sanctions for this ingredient FR 24512, May 4, 2004; 73 FR 8607, Feb. 14, different from the uses established in 2008] this section do not exist or have been waived. § 184.1307b Ferrous carbonate. (a) Ferrous carbonate (iron (II) car- [53 FR 16865, May 12, 1988; 53 FR 20939, June 7, 1988] bonate, FeCO3, CAS Reg. No. 563–71–3) is an odorless, white solid prepared by § 184.1307 Ferric sulfate. treating solutions of iron (II) salts with alkali carbonate salts. (a) Ferric sulfate (iron (III) sulfate, (b) The ingredient must be of a pu- Fe2(SO4)3 CAS Reg. No. 10028–22–5) is a rity suitable for its intended use. yellow substance that may be prepared (c) In accordance with § 184.1(b)(1), by oxidizing iron (II) sulfate or by the ingredient is used in food as a nu- treating ferric oxide or ferric hydrox- trient supplement as defined in ide with sulfuric acid. § 170.3(o)(20) of this chapter, with no (b) The ingredient must be of a pu- limitation other than current good rity suitable for its intended use. manufacturing practice. The ingre- (c) In accordance with § 184.1(b)(1), dient may also be used in infant for- the ingredient is used in food as a fla- mula in accordance with section 412(g) voring agent as defined in § 170.3(o)(12) of the Federal Foods, Drug, and Cos- of this chapter, with no limitation metic Act (the act) (21 U.S.C. 350a(g)) other than current good manufacturing or with regulations promulgated under practice. section 412(a)(2) of the act (21 U.S.C. (d) Prior sanctions for this ingredient 350a(a)(2)). different from the uses established in (d) Prior sanctions for this ingredient this section do not exist or have been different from the uses established in this section do not exist or have been waived. waived. [53 FR 16865, May 12, 1988, as amended at 73 [53 FR 16865, May 12, 1988, as amended at 73 FR 8607, Feb. 14, 2008] FR 8607, Feb. 14, 2008]

§ 184.1307a Ferrous ascorbate. § 184.1307c Ferrous citrate. (a) Ferrous ascorbate (CAS Reg. No. (a) Ferrous citrate (iron (II) citrate, 24808–52–4) is a reaction product of fer- (C6H6FeO7), CAS Reg. No. 23383–11–1) is rous hydroxide and ascorbic acid. It is a slightly colored powder or white a blue-violet product containing 16 per- crystals. It is prepared from the reac- cent iron. tion of sodium citrate with ferrous sul- (b) The ingredient must be of a pu- fate or by direct action of citric acid on rity suitable for its intended use. iron filings. (c) In accordance with § 184.1(b)(1), (b) The ingredient must be of a pu- the ingredient is used in food as a nu- rity suitable for its intended use. trient supplement as defined in (c) In accordance with § 184.1(b)(1) the § 170.3(o)(20) of this chapter, with no ingredient is used in food as a nutrient limitation other than current good supplement as defined in § 170.3(o)(20) of manufacturing practice. The ingre- this chapter, with no limitation other dient may also be used in infant for- than current good manufacturing prac- mula in accordance with section 412(g) tice. The ingredient may also be used in infant formula in accordance with of the Federal Food, Drug, and Cos- section 412(g) of the Federal Food, metic Act (the act) (21 U.S.C. 350a(g)) Drug, and Cosmetic Act (the act) (21 or with regulations promulgated under U.S.C. 350a(g)) or with regulations pro- section 412(a)(2) of the act (21 U.S.C. mulgated under section 412(a)(2) of the 350a(a)(2)). act (21 U.S.C. 350a(a)(2)). (d) Prior sanctions for this ingredient (d) Prior sanctions for this ingredient different from the uses established in different from the uses established in

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this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the Food Chemcials Codex, 3d Ed. (1981), pp. 122–123, which is incor- [53 FR 16866, May 12, 1988, as amended at 73 porated by reference. Copies are avail- FR 8607, Feb. 14, 2008] able from the National Academy Press, § 184.1307d Ferrous fumarate. 2101 Constitution Avenue NW., Wash- ington, DC 20418, or available for in- (a) Ferrous fumarate (iron (II) fuma- spection at the National Archives and rate, (C4H2FeO4), CAS Reg. No. 141–01–5) Records Administration (NARA). For is an odorless, reddish-orange to red- information on the availability of this dish-brown powder. It may contain soft material at NARA, call 202–741–6030, or lumps that produce a yellow streak go to: http://www.archives.gov/ when crushed. It is prepared by federallregister/ admixing hot solutions of ferrous sul- codeloflfederallregulations/ fate and sodium fumarate. ibrllocations.html. (b) The ingredient meets the speci- (c) In accordance with § 184.1(b)(1), fications of the Food Chemicals Codex, the ingredient is used in food as a nu- 3d Ed. (1981), pp. 120–122, which is incor- trient supplement as defined in porated by reference. Copies are avail- § 170.3(o)(20) of this chapter, with no able from the National Academy Press, limitation other than current good 2101 Constitution Ave NW., Wash- manufacturing practice. The ingre- ington, DC 20418, or available for in- dient may also be used in infant for- spection at the National Archives and mula in accordance with section 412(g) Records Administration (NARA). For of the Federal Food, Drug, and Cos- information on the availability of this metic Act (the act) (21 U.S.C. 350a(g)) material at NARA, call 202–741–6030, or or with regulations promulgated under go to: http://www.archives.gov/ section 412(a)(2) of the act (21 U.S.C. federallregister/ 350a(a)(2)). codeloflfederallregulations/ (d) Prior sanctions for this ingredient ibrllocations.html. different from the uses established in this section do not exist or have been (c) In accordance with § 184.1(b)(1) the waived. ingredient is used in food as a nutrient supplement as defined in § 170.3(o)(20) of [53 FR 16866, May 12, 1988; 53 FR 20939, June this chapter, with no limitation other 7, 1988] than current good manufacturing practice. The ingredient may also be used § 184.1311 Ferrous lactate. in infant formula in accordance with (a) Ferrous lactate (iron (II) lactate, section 412(g) of the Federal Food, C6H10FeO6, CAS Reg. No. 5905–52–2) in Drug, and Cosmetic Act (the act) (21 the trihydrate form is a greenish-white U.S.C. 350a(g)), or with regulations pro- powder or crystalline mass. It is pre- mulgated under section 412(a)(2) of the pared by reacting calcium lactate or act (21 U.S.C. 350a(a)(2)). sodium lactate with ferrous sulfate, di- (d) Prior sanctions for this ingredient rect reaction of lactic acid with iron different from the uses established in filings, reaction of ferrous chloride this section do not exist or have been with sodium lactate, or reaction of fer- waived. rous sulfate with ammonium lactate. (b) The ingredient meets the speci- [53 FR 16866, May 12, 1988] fications of the Food Chemicals Codex, 4th ed. (1996), pp. 154 to 155, which is in- § 184.1308 Ferrous gluconate. corporated by reference in accordance (a) Ferrous gluconate (iron (II) gluco- with 5 U.S.C. 552(a) and 1 CFR part 51. nate dihydrate, C12H22FeO14·2H2O, CAS Copies are available from the National Reg. No. 6047-12-7) is a fine yellowish- Academy Press, 2101 Constitution Ave. gray or pale greenish-yellow powder or NW., Washington, DC 20418, or may be granules. It is prepared by reacting hot examined at the Center for Food Safety solutions of barium or calcium gluco- and Applied Nutrition’s library, 5100 nate with ferrous sulfate or by heating Paint Branch Pkwy., College Park, MD freshly prepared ferrous carbonate with 20740, or at the National Archives and gluconic acid in aqueous solution. Records Administration (NARA). For

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information on the availability of this (c) In accordance with § 184.1(b)(1), material at NARA, call 202–741–6030, or the ingredients are used in food as nu- go to: http://www.archives.gov/ trient supplements as defined in federallregister/ § 170.3(o)(20) of this chapter and as a codeloflfederallregulations/ processing aid as defined in § 170.3(o)(24) ibrllocations.html. of this chapter, with no limitation (c) In accordance with § 184.1(b)(1), other than current good manufacturing the ingredient is used in food as a nu- practice. The ingredients may also be trient supplement as defined in used in infant formula in accordance § 170.3(o)(20) of this chapter and as a with section 412(g) of the Federal Food, color fixative for ripe olives, with no Drug, and Cosmetic Act (the act) (21 other limitation other than current U.S.C. 350a(g)) or with regulations pro- good manufacturing practice. The in- mulgated under section 412(a)(2) of the gredient may also be used in infant for- act (21 U.S.C. 350a(a)(2)). mula in accordance with section 412(g) (d) Prior sanctions for these ingredi- of the Federal Food, Drug, and Cos- ents different from the uses established metic Act (the act) (21 U.S.C. 350a(g)) in this section do not exist or have or with regulations promulgated under been waived. section 412(a)(2) of the act (21 U.S.C. [53 FR 16866, May 12, 1988] 350a(a)(2)). (d) Prior sanctions for this ingredient § 184.1316 Ficin. different from the uses established in this section do not exist or have been (a) Ficin (CAS Reg. No. 9001–33–6) is waived. an enzyme preparation obtained from the latex of species of the genus Ficus, [53 FR 16866, May 12, 1988, as amended at 61 which include a variety of tropical fig FR 40319, Aug. 2, 1996] trees. It is a white to off-white powder. Its characterizing enzyme activity is § 184.1315 Ferrous sulfate. that of a peptide hydrolase (EC (a) Ferrous sulfate heptahydrate 3.4.22.3). (iron (II) sulfate heptahydrate, (b) The ingredient meets the general FeSO4·7H2O, CAS Reg. No. 7782–63–0) is requirements and additional require- prepared by the action of sulfuric acid ments for enzyme preparations in the on iron. It occurs as pale, bluish-green Food Chemicals Codex, 3d ed. (1981), p. crystals or granules. Progressive heat- 110, which is incorporated by reference ing of ferrous sulfate heptahydrate pro- in accordance with 5 U.S.C. 552(a) and 1 duces ferrous sulfate (dried). Ferrous CFR part 51. Copies are available from sulfate (dried) consists primarily of fer- the National Academy Press, 2101 Con- rous sulfate monohydrate (CAS Reg. stitution Ave., NW., Washington, DC No. 17375–41–6) with varying amounts of 20418, or may be examined at the Office ferrous sulfate tetrahydrate (CAS Reg. of Premarket Approval (HFS–200), Food No. 20908–72–9) and occurs as a grayish- and Drug Administration, 5100 Paint white to buff-colored powder. Branch Pkwy., College Park, MD 20740, (b) The ingredients meet the speci- and at the National Archives and fications of the Food Chemicals Codex, Records Administration (NARA). For 3d Ed. (1981), p. 123 (Ferrous sulfate information on the availability of this heptahydrate) and p. 124 (ferrous sul- material at NARA, call 202–741–6030, or fate, dried), which is incorporated by go to: http://www.archives.gov/ reference. Copies are available from federallregister/ the National Academy Press, 2101 Con- codeloflfederallregulations/ stitution Ave., NW., Washington, DC ibrllocations.html. 20418, or available for inspection at the (c) In accordance with § 184.1(b)(1), National Archives and Records Admin- the ingredient is used in food with no istration (NARA). For information on limitation other than current good the availability of this material at manufacturing practice. The affirma- NARA, call 202–741–6030, or go to: http:// tion of this ingredient as GRAS as a di- www.archives.gov/federallregister/ rect food ingredient is based upon the codeloflfederallregulations/ following current good manufacturing ibrllocations.html. practice conditions of use:

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(1) The ingredient is used as an en- to man or other animals, or by the oxi- zyme as defined in § 170.3(o)(9) of this dation of D-glucose with enzymes de- chapter to hydrolyze proteins or rived from these microorganisms. polypeptides. (b) The ingredient meets the speci- (2) The ingredient is used in food at fications of the Food Chemicals Codex, levels not to exceed current good man- 3d Ed. (1981), p. 134, which is incor- ufacturing practice. porated by reference. Copies are available from the National Academy Press, [60 FR 32910, June 26, 1995] 2101 Constitution Ave. NW., Wash- § 184.1317 Garlic and its derivatives. ington, DC 20418, or available for inspection at the National Archives and (a) Garlic is the fresh or dehydrated Records Administration (NARA). For bulb or cloves obtained from Allium information on the availability of this sativum, a genus of the lily family. Its material at NARA, call 202–741–6030, or derivatives include essential oils, oleo- go to: http://www.archives.gov/ resins, and natural extractives ob- federallregister/ tained from garlic. codeloflfederallregulations/ (b) Garlic oil meets the specifications ibrllocations.html. of the ‘‘Food Chemicals Codex,’’ 3d Ed. (c) In accordance with § 184.1(b)(1), (1981), p. 132, which is incorporated by the ingredient is used in food with no reference. Copies may be obtained from limitation other than current good the National Academy Press, 2101 Con- manufacturing practice. The affirma- stitution Ave. NW., Washington, DC tion of this ingredient as generally rec- 20418, or may be examined at the Na- ognized as safe (GRAS) as a direct tional Archives and Records Adminis- human food ingredient is based upon tration (NARA). For information on the following current good manufac- the availability of this material at turing practice conditions of use: NARA, call 202–741–6030, or go to: http:// (1) The ingredient is used as a curing www.archives.gov/federallregister/ and pickling agent as defined in codeloflfederallregulations/ § 170.3(o)(5) of this chapter, leavening ibrllocations.html. agent as defined in § 170.3(o)(17) of this (c) Garlic and its derivatives are used chapter; pH control agent as defined in as flavoring agents and adjuvants as § 170.3(o)(23) of this chapter; and defined in § 170.3(o)(12) of this chapter. sequestrant as defined in § 170.3(o)(26) of (d) The ingredients are used in food this chapter. at levels not to exceed good manufac- (2) The ingredient is used at levels turing practice. not to exceed current good manufac- (e) [Reserved] turing practice. (f) Prior sanctions for this ingredient (d) Prior sanctions for this ingredient different from the uses established in different from the uses established in this section do not exist or have been this section do not exist or have been waived. waived. [42 FR 14653, Mar. 15, 1977, as amended at 42 [51 FR 33896, Sept. 24, 1986] FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, 1984] § 184.1321 Corn gluten. (a) Corn gluten (CAS Reg. No. 66071– § 184.1318 Glucono delta-lactone. 96–3), also known as corn gluten meal, (a) Glucono delta-lactone (C6H10O6, is the principal protein component of CAS Reg. No. 90–80–2), also called D- corn endosperm. It consists mainly of gluconic acid delta-lactone or D- zein and glutelin. Corn gluten is a by- glucono-1,5-lactone, is the cyclic 1,5- product of the wet milling of corn for intramolecular ester of D-gluconic starch. The gluten fraction is washed acid. It is prepared by direct crys- to remove residual water soluble pro- tallization from the aqueous solution teins. Corn gluten is also produced as a of gluconic acid. Gluconic acid may be byproduct during the conversion of the produced by the oxidation of D-glucose starch in whole or various fractions of with bromine water, by the oxidation dry milled corn to corn syrups. of D-glucose by microorganisms that (b) The ingredient must be of a pu- are nonpathogenic and nontoxicogenic rity suitable for its intended use.

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(c) In accordance with § 184.1(b)(1), (2) The ingredient is used in food at the ingredient is used in food with no levels not to exceed current good man- limitation other than current good ufacturing practice. manufacturing practice. The affirma- (d) Prior sanctions for this ingredient tion of this ingredient as generally rec- different from the uses established in ognized as safe (GRAS) as a direct this section do not exist or have been human food ingredient is based upon waived. the following current good manufacturing practice conditions of use: [50 FR 8998, Mar. 6, 1985, as amended at 73 FR (1) The ingredient is used as a nutri- 8607, Feb. 14, 2008] ent supplement as defined in § 170.3(o)(20) of this chapter and a § 184.1323 Glyceryl monooleate. texturizer as defined in § 170.3(o)(32) of (a) Glyceryl monooleate is prepared this chapter. by esterification of commerical oleic (2) The ingredient is used in food at acid that is derived either from edible levels not to exceed current good man- sources or from tall oil fatty acids ufacturing practice. meeting the requirements of § 172.862 of (d) Prior sanctions for this ingredient this chapter. It contains glyceryl different from the uses established in monooleate (C21H40O4, CAS Reg. No. this section do not exist or have been 25496–72–4) and glyceryl esters of fatty waived. acids present in commercial oleic acid. [50 FR 8998, Mar. 6, 1985, as amended at 73 FR (b) The ingredient must be of a pu- 8607, Feb. 14, 2008] rity suitable for its intended use. (c) In accordance with § 184.1(b)(1), § 184.1322 Wheat gluten. the ingredient is used in food with no (a) Wheat gluten (CAS Reg. No. 8002– limitation other than current good 80–0) is the principal protein compo- manufacturing practice. The affirma- nent of wheat and consists mainly of tion of this ingredient as generally rec- gliadin and glutenin. Wheat gluten is ognized as safe (GRAS) as a direct obtained by hydrating wheat flour and human food ingredient is based upon mechanically working the sticky mass the following current good manufac- to separate the wheat gluten from the turing practice conditions of use: starch and other flour components. (1) The ingredient is used as a fla- Vital gluten is dried gluten that has re- voring agent and adjuvant as defined in tained its elastic properties. § 170.3(o)(12) of this chapter and as a (b) The ingredient must be of a pu- solvent and vehicle as defined in rity suitable for its intended use. § 170.3(o)(27) of this chapter. (c) In accordance with § 184.1(b)(1), (2) The ingredient is used in the fol- the ingredient is used in food with no lowing foods at levels not to exceed limitation other than current good current good manufacturing practice: manufacturing practice. The affirma- baked goods and baking mixes as de- tion of this ingredient as generally rec- fined in § 170.3(n)(1) of this chapter; ognized as safe (GRAS) as a direct nonalcoholic beverages and beverage human food ingredient is based upon bases as defined in § 170.3(n)(3) of this the following current good manufac- chapter; chewing gum as defined in turing practice conditions of use: § 170.3(n)(6) of this chapter; and meat (1) The ingredient is used as a dough products as defined in § 170.3(n)(29) of strengthener as defined in § 170.3(o)(6) this chapter. of this chapter; a formulation aid as (d) Prior sanctions for this ingredient defined in § 170.3(o)(14) of this chapter; different from the use established in a nutrient supplement as defined in this section do not exist or have been § 170.3(o)(20) of this chapter; a proc- waived. essing aid as defined in § 170.3(o)(24) of this chapter; a stabilizer and thickener [54 FR 7403 Feb. 21, 1989, as amended at 73 FR as defined in § 170.3(o)(28) of this chap- 8607, Feb. 14, 2008] ter; a surface-finishing agent as defined in § 170.3(o)(30) of this chapter; and a § 184.1324 Glyceryl monostearate. texturizing agent as defined in (a) Glyceryl monostearate, also § 170.3(o)(32) of this chapter. known as monostearin, is a mixture of

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variable proportions of glyceryl mono- (2) The ingredient is used in excipient stearate (C21H42O4, CAS Reg. No. 31566– formulations for use in tablets at levels 31–1), glyceryl monopalmitate not to exceed good manufacturing (C19H38O4, CAS Reg. No. 26657–96–5) and practice. glyceryl esters of fatty acids present in commercial stearic acid. Glyceryl [52 FR 42430, Nov. 5, 1987] monostearate is prepared by § 184.1329 Glyceryl palmitostearate. glycerolysis of certain fats or oils that are derived from edible sources or by (a) Glyceryl palmitostearate is a esterification, with glycerin, of stearic mixture of mono-, di-, and triglyceryl acid that is derived from edible esters of palmitic and stearic acids sources. made from glycerin, palmitic acid, and (b) The ingredient must be of a pu- stearic acid. rity suitable for its intended use. (b) The ingredient meets the fol- (c) In accordance with § 184.1(b)(1), lowing specifications: the ingredient is used in food with no (1) The substance is a mixture of limitation other than current good mono-, di-, and triglycerides of pal- manufacturing practice. mitic acid and stearic acid. (d) Prior sanctions for this ingredient (2) Heavy metals (as lead): Not more different from the uses established in than 10 parts per million. this section do not not exist or have (c) In accordance with § 184.1(b)(1), been waived. the ingredient is used in food with no limitation other than current good [54 FR 7403 Feb. 21, 1989, as amended at 73 FR manufacturing practice. The affirma- 8607, Feb. 14, 2008] tion of this ingredient as generally rec- § 184.1328 Glyceryl behenate. ognized as safe (GRAS) as a direct human food ingredient is based upon (a) Glyceryl behenate is a mixture of the following current good manufac- glyceryl esters of behenic acid made turing practice conditions of use: from glycerin and behenic acid (a satu- (1) The ingredient is used as a formu- rated C22 fatty acid). The mixture con- lation aid, as defined in § 170.3(o)(14) of tains predominately glyceryl this chapter. dibehenate. (2) The ingredient is used in excipient (b) The ingredient meets the fol- formulations for use in tablets at levels lowing specifications: not to exceed good manufacturing (1) 10 to 20 percent monoglyceride, 47 practice. to 59 percent diglyceride, 26 to 38 percent triglyceride, and not more than [60 FR 63621, Dec. 12, 1995] 2.5 percent free fatty acids. (2) Behenic acid. Between 80 and 90 § 184.1330 Acacia (gum arabic). percent of the total fatty acid content. (a) Acacia (gum arabic) is the dried (3) Acid value. Not more than 4. gummy exudate from stems and (4) Saponification value. Between 145 branches of trees of various species of and 165. the genus Acacia, family Leguminosae. (5) Iodine number. Not more than 3. (b) The ingredient meets the speci- (6) Heavy metals (as Pb). Not more fications of the ‘‘Food Chemicals than 10 parts per million. Codex,’’ 3d Ed. (1981), p. 7, which is in- (c) In accordance with § 184.1(b)(1) of corporated by reference. Copies may be this chapter, the ingredient is used in obtained from the National Academy food with no limitation other than cur- Press, 2101 Constitution Ave. NW., rent good manufacturing practice. The Washington, DC 20418, or may be exam- affirmation of this ingredient is gen- ined at the National Archives and erally recognized as safe (GRAS) as a Records Administration (NARA). For direct human food ingredient is based information on the availability of this upon the following current good manu- material at NARA, call 202–741–6030, or facturing practice conditions of use: go to: http://www.archives.gov/ (1) The ingredient is used as a formu- federallregister/ lation aid, as defined in § 170.3(o)(14) of codeloflfederallregulations/ this chapter. ibrllocations.html.

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MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Beverages and beverage bases, § 170.3(n)(3) of this chapter 2.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Chewing gum, §170.3(n)(6) of this chapter ...... 5.6 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; humectant, § 170.3(o)(16) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chapter. Confections and frostings, § 170.3(n)(9) of this chapter ...... 12.4 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chapter. Dairy product analogs, § 170.3(n)(10) of this chapter ...... 1.3 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Fats and oils, § 170.3(n)(12) of this chapter ...... 1.5 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Gelatins, puddings, and fillings, § 170.3(n)(22) of this chapter 2.5 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; formulation aid, § 170.3(o)(14) of this chapter.; stabilizer and thickener, § 170.3(o)(28) of this chapter. Hard candy and cough drops, § 170.3(n)(25) of this chapter .. 46.5 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter. Nuts and nut products, § 170.3(n)(32) of this chapter ...... 8.3 Formulation aid, § 170.3(o)(14) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chapter. Quiescently frozen confection products ...... 6.0 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Snack foods, §170.3(n)(37) of this chapter ...... 4.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; formulation aid, § 170.3(o)(14) of this chapter. Soft candy, §170.3(n)(38) of this chapter ...... 85.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; firming agent, § 170.3(o)(10) of this chapter; flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter, humectant, § 170.3(o)(16) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chapter. All other food categories ...... 1.0 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; processing aid, § 170.3(o)(24) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chapter; texturizer, § 170.3(o)(32) of this chapter.

(d) [Reserved] in the dry deciduous forests of India (e) Prior sanctions for this ingredient and Ceylon. different from the uses established in (b) The ingredient complies with the this section do not exist or have been following specifications: waived. (1) Viscosity of a 1-percent solution. Not less than the minimum or within [42 FR 14653, Mar. 15, 1977, as amended at 42 the range claimed by the vendor. FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, (2) Limits of impurities—(i) Arsenic (as 1983; 53 FR 5766, Feb. 26, 1988] AL). Not more than 3 parts per million § 184.1333 Gum ghatti. (0.0003 percent); (ii) Ash (acid-insoluble). Not more (a) Gum ghatti (Indian gum) is an than 1.75 percent; exudate from wounds in the bark of (iii) Ash (total). Not more than 6.0 Anogeissus latifolia, a large tree found percent;

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(iv) Heavy metals (as Pb). Not more may be examined at the National Ar- than 40 parts per million (0.004 per- chives and Records Administration cent); and (NARA). For information on the avail- (v) Lead. Not more than 10 parts per ability of this material at NARA, call million (0.001 percent). 202–741–6030, or go to: http:// (3) Loss on drying. Not more than 14 www.archives.gov/federallregister/ percent dried at 105 °C for 5 hours. codeloflfederallregulations/ (4) Identification test. Add 0.2 ml of di- ibrllocations.html.), to 5 ml of a cold 1- luted lead acetate as outlined in ‘‘Offi- in-100 aqueous solution of the gum. An cial Methods of Analysis of the Asso- immediate, voluminous, opaque pre- ciation of Official Analytical Chem- cipitate indicates acacia. A small pre- ists,’’ 13th Ed. (1980), section 31.178(b), cipitate or clear solution which pro- p. 529, under ‘‘Dilute Basic Lead Ace- duces an opaque flocculent precipitate tate Standard Solution,’’ which is in- upon the addition of 1 ml of 3 N corporated by reference (Copies are ammonimum hydroxide indicates gum available from the AOAC INTER- ghatti. NATIONAL, 481 North Frederick Ave., (c) The ingredient is used in food suite 500, Gaithersburg, MD 20877, or under the following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Beverages and beverage bases, nonalcoholic, 0.2 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter. § 170.3(n)(3) of this chapter. All other food categories ...... 1 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter.

(d) Prior sanctions for this ingredient Codex,’’ 3d Ed. (1981), p. 141, which is in- different from the uses established in corporated by reference. Copies may be this section do not exist or have been obtained from the National Academy waived. Press, 2101 Constitution Ave. NW., [42 FR 14653, Mar. 15, 1977, as amended at 49 Washington, DC 20418, or may be exam- FR 5612, Feb. 14, 1984] ined at the National Archives and Records Administration (NARA). For § 184.1339 Guar gum. information on the availability of this (a) Guar gum is the natural sub- material at NARA, call 202–741–6030, or stance obtained from the maceration of go to: http://www.archives.gov/ the seed of the guar plant, Cyamopsis federallregister/ tetragonoloba (Linne) Taub., or codeloflfederallregulations/ Cyamopsis psoraloides (Lam.) D.C. ibrllocations.html. (b) The ingredient meets the speci- (c) The ingredient is used in food fications of the ‘‘Food Chemicals under the following conditions:

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Baked goods and baking mixes, § 170.3(n)(1) of this chapter 0.35 Emulsifier and emulsifier salts, § 170.3(o)(8) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener; § 170.3(o)(28) of this chapter. Breakfast cereals, §170.3(n)(4) of this chapter ...... 1.2 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Cheese, § 170.3(n)(5) of this chapter ...... 8 Do. Dairy products analogs, § 170.3(n)(10) of this chapter ...... 1.0 Firming agent, § 170.3(o)(10) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Fats and oils, § 170.3(n)(12) of this chapter ...... 2.0 Do. Gravies and sauces, § 170.3(n)(24) of this chapter ...... 1.2 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Jams and jellies, commercial, § 170.3(n)(28) of this chapter .. 1.0 Do. Milk products, § 170.3(n)(31) of this chapter ...... 6 Do. Processed vegetables and vegetable juices, § 170.3(n)(36) of 2.0 Formulation aid, § 170.3(o)(14) of this chapter; sta- this chapter. bilizer and thickener, § 170.3(o)(28) of this chapter.

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MAXIMUM USAGE LEVELS PERMITTED—Continued

Food (as served) Percent Function

Soups and soup mixes, § 170.3(n)(40) of this chapter ...... 8 Do. Sweet sauces, toppings and syrups, § 170.3(n)(43) of this 1.0 Do. chapter. All other food categories ...... 5 Emulsifier and emulsifier salts, § 170.3(o)(8) of this chapter; firming agent, § 170.3(o)(10) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter.

(d) [Reserved] Codex,’’ 3d Ed. (1981), pp. 174–175, which (e) Prior sanctions for this ingredient is incorporated by reference. Copies different from the uses established in may be obtained from the National this section do not exist or have been Academy Press, 2101 Constitution Ave. waived. NW., Washington, DC 20418, or may be [42 FR 14653, Mar. 15, 1977, as amended at 42 examined at the National Archives and FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, Records Administration (NARA). For 1984] information on the availability of this material at NARA, call 202–741–6030, or § 184.1343 Locust (carob) bean gum. go to: http://www.archives.gov/ (a) Locust (carob) bean gum is pri- federallregister/ marily the macerated endosperm of the codeloflfederallregulations/ seed of the locust (carob) bean tree, ibrllocations.html. Ceratonia siliqua (Linne), a leguminous (c) The ingredient is used at levels evergreen tree, with lesser quantities not to exceed the following maximum of seed coat and germ. (b) The ingredient meets the speci- levels: fications of the ‘‘Food Chemicals

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Baked goods and baking mixes, § 170.3(n)(1) of this 0.15 Stabilizer and thickener, § 170.3(o)(28) of this chapter. chapter. Beverages and beverage bases, nonalcoholic, .25 Do. § 170.3(n)(3) of this chapter. Cheeses, § 170.3(n)(5) of this chapter ...... 8 Do. Gelatins, puddings, and fillings, § 170.3(n)(22) of this .75 Do. chapter. Jams and jellies, commercial, § 170.3(n)(28) of this .75 Do. chapter. All other food categories ...... 5 Do.

(d) [Reserved] (b) The ingredient meets the speci- (e) Prior sanctions for this ingredient fications of the ‘‘Food Chemicals different from the uses established in Codex,’’ 3d Ed. (1981), p. 157, which is in- this regulation do not exist or have corporated by reference. Copies may be been waived. obtained from the National Academy Press, 2101 Constitution Ave. NW., [42 FR 14653, Mar. 15, 1977, as amended at 42 Washington, DC 20418, or may be exam- FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, ined at the National Archives and 1984] Records Administration (NARA). For information on the availability of this § 184.1349 Karaya gum (sterculia gum). material at NARA, call 202–741–6030, or (a) Karaya gum (sterculia gum) is the go to: http://www.archives.gov/ dried gummy exudate from the trunk federallregister/ of trees of various species of the genus codeloflfederallregulations/ Sterculia. ibrllocations.html.

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MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Frozen dairy desserts and mixes, § 170.3(n)(20) of 0.3 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and this chapter. thickener, § 170.3(o)(28) of this chapter. Milk products, § 170.3(n)(31) of this chapter ...... 02 Stabilizer and thickener, § 170.3(o)(28) of this chapter. Soft candy, § 170.3(n)(38) of this chapter ...... 9 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. All other food categories ...... 002 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter.

(d) [Reserved] Codex,’’ 3d Ed. (1981), p. 337, which is in- (e) Prior sanctions for this ingredient corporated by reference. Copies may be different from the uses established in obtained from the National Academy this section do not exist or have been Press, 2101 Constitution Ave. NW., waived. Washington, DC 20418, or may be exam- [42 FR 14653, Mar. 15, 1977, as amended at 42 ined at the National Archives and FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, Records Administration (NARA). For 1984] information on the availability of this material at NARA, call 202–741–6030, or § 184.1351 Gum tragacanth. go to: http://www.archives.gov/ (a) Gum tragacanth is the exudate federallregister/ from one of several species of Astrag- codeloflfederallregulations/ alus gummifier Labillardiere, a shrub ibrllocations.html. that grows wild in mountainous re- (c) The ingredient is used in food gions of the Middle East. under the following conditions: (b) The ingredient meets the specifications of the ‘‘Food Chemicals

MAXIMUM USAGE LEVELS PERMITTED

Food (as served) Percent Function

Baked goods and baking mixes, § 170.3(n)(1) of this 0.2 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; chapter. formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Condiments and relishes, § 170.3(n)(8) of this chap- .7 Do. ter. Fats and oils, § 170.3(n)(12) of this chapter ...... 1.3 Do. Gravies and sauces, § 170.3(n)(24) of this chapter .. .8 Do. Meat products, § 170.3(n)(29) of this chapter ...... 2 Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. Processed fruits and fruit juices, § 170.3(n)(35) of .2 Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; this chapter. formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. All other food categories ...... 1 Do.

(d) [Reserved] § 184.1355 Helium. (e) Prior sanctions for this ingredient (a) Helium (empirical formula He, different from the uses established in CAS Reg. No. 7440–59–7) is a colorless, this section do not exist or have been odorless, flavorless, nonflammable, waived. inert gas. It is lighter than air and is [42 FR 14653, Mar. 15, 1977, as amended at 42 produced by the liquefaction and puri- FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, fication of natural gas. 1984] (b) The ingredient must be of a purity suitable for its intended use. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no

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limitations other than current good hydrogen dioxide. It is made by the manufacturing practice. The affirma- electrolytic oxidation of sulfuric acid tion of this ingredient as generally rec- or a sulfate to persulfuric acid or a ognized as safe (GRAS) as a direct persulfuric acid salt with subsequent human food ingredient is based upon hydrolysis and distillation of the hy- the following current good manufac- drogen peroxide formed; by decomposi- turing practice conditions of use: tion of barium peroxide with sulfuric (1) The ingredient is used as a proc- or phosphoric acid; by hydrogen reduc- essing aid as defined in § 170.3(o)(24) of tion of 2-ethylanthraquinone, followed this chapter. by oxidation with air, to regenerate (2) The ingredient is used in food at levels not to exceed current good man- the quinone and produce hydrogen per- ufacturing practice. oxide; or by electrical discharge (d) Prior sanctions for this ingredient through a mixture of hydrogen, oxy- different from the uses established in gen, and water vapor. this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the Food Chemicals Codex, 3d ed. (1981), pp. 146–147, 1 which is in- [48 FR 57270, Dec. 29, 1983, as amended at 73 FR 8607, Feb. 14, 2008] corporated by reference. (c) In accordance with § 184.1(b)(2), § 184.1366 Hydrogen peroxide. the ingredient is used to treat food only within the following specific limi- (a) Hydrogen peroxide (H2O2, CAS Reg. No. 7722–84–1) is also referred to as tations:

Maximum treatment Food level in food (percent) Functional use

Milk, intended for use during the cheesemaking 0.05 ...... Antimicrobial agent as defined in § 170.3 (o)(2) of process as permitted in the appropriate stand- this chapter ards of identity for cheese and related cheese products under part 133 of this chapter. Whey, during the preparation of modified whey by 0.04 ...... do. electrodialysis methods. Dried eggs, dried egg whites, and dried egg yolks Amount sufficient for Oxidizing and reducing agent as defined in § 170.3 as in §§ 160.105, 160.145, and 160.185 of this the purpose. (o)(22) of this chapter chapter. Tripe ...... do ...... Bleaching agent. Beef feet ...... Amount sufficient for Bleaching agent. the purpose. (Hy- drogen peroxide may be in the form of a compound salt, sodium carbonate peroxide). Herring ...... Amount sufficient for do. the purpose. Wine ...... do ...... Oxidizing and reducing agent as defined in § 170.3 (o)(22) of this chapter. Starch ...... 0.15 ...... Antimicrobial agent as defined in § 170.3 (o)(2) of this chapter, to produce thermophile-free starch; Remove sulfur dioxide from starch slurry following steeping and grinding operations of corn refining. Instant tea ...... Amount sufficient for Bleaching agent. the purpose. Corn syrup ...... 0.15 ...... Reduce sulfur dioxide levels in the finished corn syrup. Colored (annatto) cheese whey ...... 0.05 ...... Bleaching agent. Wine vinegar ...... Amount sufficient for Remove sulfur dioxide from wine prior to fermenta- the purpose. tion to produce vinegar. Emulsifiers containing fatty acid esters ...... 1.25 ...... Bleaching agent.

1 Copies may be obtained from the National availability of this material at NARA, call Academy of Sciences, 2101 Constitution Ave. 202–741–6030, or go to: http://www.archives.gov/ NW, Washington, DC 20037, or examined at federallregister/codeloflfederallregulations/ the National Archives and Records Adminis- ibrllocations.html. tration (NARA). For information on the

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(d) Residual hydrogen peroxide is re- this section do not exist or have been moved by appropriate physical and waived. chemical means during the processing [47 FR 38278, Aug. 31, 1982] of food where it has been used accord- ing to paragraph (c) of this section. § 184.1372 Insoluble glucose isomerase (e) Prior sanctions for this ingredient enzyme preparations. different from the uses established in this section do not exist or have been (a) Insoluble glucose isomerase en- waived. zyme preparations are used in the production of high fructose corn syrup de- [46 FR 44439, Sept. 4, 1981, as amended at 51 scribed in § 184.1866. They are derived FR 27172, July 30, 1986] from recognized species of precisely classified nonpathogenic and § 184.1370 Inositol. nontoxicogenic microorganisms, in- (a) Inositol, or myo-inositol (C6H12O6, cluding Streptomyces rubiginosus, CAS Reg. No. 87–89–8), is cis-1,2,3,5- Actinoplanes missouriensis, Streptomyces trans-4,6-cyclohexanehexol. It occurs olivaceus, Streptomyces olivochromogenes, naturally and is prepared from an and Bacillus coagulans, that have been aqueous (0.2 percent sulfur dioxide) ex- grown in a pure culture fermentation tract of corn kernels by precipitation that produces no antibiotics. They are and hydrolysis of crude phytate. fixed (rendered insoluble) for batch (b) The ingredient meets the speci- production with GRAS ingredients or fications of the Food Chemicals Codex, may be fixed for further immobiliza- 3d Ed. (1981), p. 150, which is incor- tion with either GRAS ingredients or porated by reference. Copies are avail- materials approved under § 173.357 of able from the National Academy Press, this chapter. 2101 Constitution Ave. NW., Wash- (b) The ingredient meets the general ington, DC 20418, or available for in- and additional requirements for en- spection at the National Archives and zyme preparations in the Food Chemi- Records Administration (NARA). For cals Codex, 3d Ed. (1981), p. 107, which is information on the availability of this incorporated by reference. Copies are material at NARA, call 202–741–6030, or available from the National Academy go to: http://www.archives.gov/ Press, 2101 Constitution Ave. NW., federallregister/ Washington, DC 20418, or available for codeloflfederallregulations/ ibrllocations.html. inspection at the National Archives (c) In accordance with § 184.1(b)(1), and Records Administration (NARA). the ingredient is used in food with no For information on the availability of limitations other than current good this material at NARA, call 202–741– manufacturing practice. The affirma- 6030, or go to: http://www.archives.gov/ tion of this ingredient as generally rec- federallregister/ ognized as safe (GRAS) as a direct codeloflfederallregulations/ human food ingredient is based upon ibrllocations.html. the following current good manufac- (c) In accordance with § 184.1(b)(1), turing practice conditions of use: the ingredient is used in food with no (1) The ingredient is used as a nutri- limitation other than current good ent supplement as defined in manufacturing practice. The affirma- § 170.3(o)(20) of this chapter. tion of this ingredient as generally rec- (2) The ingredient is used in special ognized as safe (GRAS) as a direct dietary foods as defined in part 105 of human food ingredient is based upon this chapter at levels not to exceed the following current good manufac- current good manufacturing practice. turing practice conditions of use: It may also be used in infant formula (1) The ingredient is used as an en- in accordance with section 412(g) of the zyme, as defined in § 170.3(o)(9) of this Act, or with regulations promulgated chapter, to convert glucose to fructose. under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established by

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(2) The ingredient is used in high dient may also be used in accordance fructose corn syrup, at levels not to ex- with section 412(g) of the Federal Food, ceed current good manufacturing prac- Drug, and Cosmetic Act (the act) (21 tice. U.S.C. 350a(g)) or with regulations pro- [48 FR 5720, Feb. 8, 1983, as amended at 61 FR mulgated under section 412(a)(2) of the 43450, Aug. 23, 1996] act (21 U.S.C. 350a(2)). (d) Prior sanctions for this ingredient § 184.1375 Iron, elemental. different from the uses established in (a) Iron, elemental (CAS Reg. No. this section do not exist or have been 7439–89–6) is metallic iron obtained by waived. any of the following processes: reduced [53 FR 16867, May 12, 1988] iron, electrolytic iron, and carbonyl iron. § 184.1386 Isopropyl citrate. (1) Reduced iron is prepared by react- (a) Isopropyl citrate is a mixture of ing ground ferric oxide with hydrogen the mono-, di-, and triisopropyl esters or carbon monoxide at an elevated of citric acid. It is prepared by temperature. The process results in a esterifying citric acid with grayish-black powder, all of which isopropanol. should pass through a 100-mesh sieve. (b) The ingredient must be of a pu- It is lusterless or has not more than a rity suitable for its intended use. slight luster. When viewed under a mi- (c) In accordance with § 184.1(b)(1), croscope, it appears as an amorphous the ingredient is used in food with no powder free from particles having a limitation other than current good crystalline structure. It is stable in dry manufacturing practice. The affirma- air. tion of this ingredient as generally rec- (2) Electrolytic iron is prepared by ognized as safe (GRAS) as a direct electrodeposition. It is an amorphous, human food ingredient is based upon lusterless, grayish-black powder. It is the following current good manufac- stable in dry air. (3) Carbonyl iron is prepared by the turing practice conditions of use: decomposition of iron pentacarbonyl. (1) The ingredient is used as an anti- It occurs as a dark gray powder. When oxidant as defined in § 170.3(o)(3) of this viewed under a microscope, it appears chapter; a sequestrant as defined in as spheres built up with concentric § 170.3(o)(26) of this chapter; and a sol- shells. It is stable in dry air. vent and vehicle as defined in (b) Iron, elemental (carbonyl, elec- § 170.3(o)(27) of this chapter. trolytic, or reduced) meets the speci- (2) The ingredient is used in mar- fications of the Food Chemicals Codex, garine in accordance with § 166.110 of 3d Ed. (1981) (iron, carbonyl, p. 151; this chapter; in nonalcoholic beverages iron, electrolytic, pp. 151–152; iron, re- as defined in § 170.3(n)(3) of this chap- duced; pp. 152–153), which is incor- ter; and in fats and oils as defined in porated by reference. Copies are avail- § 170.3(n)(12) of this chapter at levels able from the National Academy Press, not to exceed current good manufac- 2101 Constitution Ave. NW., Wash- turing practice. ington, DC 20418, or available for in- (d) Prior sanctions for this ingredient spection at the National Archives and different from the uses established in Records Administration (NARA). For this section, or different from those set information on the availability of this forth in part 181 of this chapter, do not material at NARA, call 202–741–6030, or exist or have been waived. go to: http://www.archives.gov/ [59 FR 63896, Dec. 12, 1994, as amended at 73 federallregister/ FR 8607, Feb. 14, 2008] codeloflfederallregulations/ ibrllocations.html. § 184.1387 Lactase enzyme preparation (c) In accordance with § 184.1(b)(1), from Candida pseudotropicalis. the ingredient is used in food as a nu- (a) This enzyme preparation is de- trient supplement as defined in rived from the nonpathogenic, § 170.3(o)(20) of this chapter, with no nontoxicogenic yeast C. limitation other than current good pseudotropicalis. It contains the enzyme manufacturing practice. The ingre- lactase (b-D-galactoside 533

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galactohydrolase, EC 3.2.1.23), which from yeast that has been grown in a converts lactose to glucose and galac- pure culture fermentation and by using tose. It is prepared from yeast that has materials that are generally recognized been grown by a pure culture fermenta- as safe or are food additives that have tion process. been approved for this use by the Food (b) The ingredient meets the general and Drug Administration. requirements and additional require- (b) The ingredient meets the general ments for enzyme preparations in the and additional requirements for en- Food Chemicals Codex, 3d ed. (1981), pp. zyme preparations in the Food Chemi- 107–110, which are incorporated by ref- cals Codex, 3d Ed. (1981), p. 107–110, erence in accordance with 5 U.S.C. which is incorporated by reference. 552(a) and 1 CFR part 51. Copies are Copies are available from the National available from the National Academy Academy Press, 2101 Constitution Ave. Press, 2101 Constitution Ave. NW., NW., Washington, DC 20418, or avail- Washington, DC 20418, or may be exam- able for inspection at the National Ar- ined at the Center for Food Safety and chives and Records Administration Applied Nutrition’s Library, 5100 Paint (NARA). For information on the avail- Branch Pkwy., College Park, MD 20740, ability of this material at NARA, call or at the National Archives and 202–741–6030, or go to: http:// Records Administration (NARA). For www.archives.gov/federallregister/ information on the availability of this codeloflfederallregulations/ material at NARA, call 202–741–6030, or ibrllocations.html. go to: http://www.archives.gov/ (c) In accordance with § 184.1(b)(1), federallregister/ the ingredient is used in food with no codeloflfederallregulations/ limitation other than current good ibrllocations.html. manufacturing practice. The affirma- (c) In accordance with § 184.1(b)(1), tion of this ingredient as generally rec- the ingredient is used in food with no ognized as safe as a direct human food limitations other than current good ingredient is based upon the following manufacturing practice. The affirma- current good manufacturing practice tion of this ingredient as generally rec- conditions of use: ognized as safe as a direct human food (1) The ingredient is used as an en- ingredient is based upon the following zyme as defined in § 170.3(o)(9) of this current good manufacturing practice chapter to convert lactose to glucose conditions of use: and galactose. (1) The ingredient is used as an en- (2) The ingredient is used in food at zyme, as defined in § 170.3(o)(9) of this levels not to exceed current good man- chapter, to convert lactose to glucose ufacturing practice. Current good man- and galactose. ufacturing practice is to use this ingre- (2) The ingredient is used in food at dient in milk to produce lactase-treat- levels not to exceed current good man- ed milk, which contains less lactose ufacturing practice. Current good man- than regular milk, or lactose-reduced ufacturing practice is limited to use of milk, which contains at least 70 per- this ingredient to reduce the lactose cent less lactose than regular milk. content in milk and milk-derived food [49 FR 47387, Dec. 4, 1984] products where food standards do not preclude such use. § 184.1400 Lecithin. [61 FR 7704, Feb. 29, 1996] (a) Commercial lecithin is a naturally occurring mixture of the § 184.1388 Lactase enzyme preparation phosphatides of choline, ethanolamine, from Kluyveromyces lactis. and inositol, with smaller amounts of (a) This enzyme preparation is de- othe lipids. It is isolated as a gum fol- rived from the nonpathogenic, lowing hydration of solvent-extracted nontoxicogenic yeast Kluyveromyces soy, safflower, or corn oils. Lecithin is lactis (previously named Saccharomyces bleached, if desired, by hydrogen per- lactis). It contains the enzyme B- oxide and benzoyl peroxide and dried galactoside galactohydrase (CAS Reg. by heating. No. CBS 683), which converts lactose to (b) The ingredient meets the speci- glucose and galactose. It is prepared fications of the Food Chemicals Codex,

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3d Ed. (1981), pp. 166–167, which is incor- the Association of Official Analytical porated by reference. Copies are avail- Chemists, 65:471–472 (1982), which are able from the National Academy Press, also incorporated by reference. Copies 2101 Constitution Ave. NW., Wash- of all of these methods are available ington, DC 20418, or available for in- from the AOAC INTERNATIONAL, 481 spection at the National Archives and North Frederick Ave., suite 500, Gai- Records Administration (NARA). For thersburg, MD 20877, or available for information on the availability of this inspection at the National Archives material at NARA, call 202–741–6030, or and Records Administration (NARA). go to: http://www.archives.gov/ For information on the availability of federallregister/ this material at NARA, call 202–741– codeloflfederallregulations/ 6030, or go to: http://www.archives.gov/ ibrllocations.html. federallregister/ (c) In accordance with § 184.1(b)(1), codeloflfederallregulations/ the ingredient is used in food with no ibrllocations.html. limitation other than current good (2) Ash. Not more than 9.5 percent for manufacturing practice. licorice, 2.5 percent for ammoniated (d) Prior sanctions for this ingredient glycyrrhizin, and 0.5 percent for different from the uses established in monoammonium glycyrrhizinate on an this section do not exist or have been anhydrous basis as determined by the waived. method in the Food Chemicals Codex, [48 FR 51150, Nov. 7, 1983] 3d Ed. (1981), p. 466, which is incorporated by reference. Copies are avail- § 184.1408 Licorice and licorice deriva- able from the National Academy Press, tives. 2101 Constitution Ave. NW., Wash- (a)(1) Licorice (glycyrrhiza) root is ington, DC 20418, or available for in- the dried and ground rhizome and root spection at the National Archives and portions of Glycyrrhiza glabra or other Records Administration (NARA). For species of Glycyrrhiza. Licorice extract information on the availability of this is that portion of the licorice root that material at NARA, call 202–741–6030, or is, after maceration, extracted by boil- go to: http://www.archives.gov/ ing water. The extract can be further federallregister/ purified by filtration and by treatment codeloflfederallregulations/ with acids and ethyl alcohol. Licorice ibrllocations.html. extract is sold as a liquid, paste (3) Acid unsoluble ash. Not more than (‘‘block’’), or spray-dried powder. (2) Ammoniated glycyrrhizin is pre- 2.5 percent for licorice on an anhydrous pared from the water extract of lico- basis as determined by the method in rice root by acid precipitation followed the Food Chemicals Codex, 3d Ed. by neutralization with dilute ammonia. (1981), p. 466, which is incorporated by Monoammonium glycyrrhizinate reference. (4) Heavy metals (as Pb). Not more (C42H61O16NH45H2O, CAS Reg. No. 1407– 03–0) is prepared from ammoniated than 40 parts per million as determined glycyrrhizin by solvent extraction and by method II in the Food Chemicals separation techniques. Codex, 3d Ed. (1981), p. 512, which is in- (b) The ingredients shall meet the corporated by reference. following specifications when analyzed: (5) Arsenic (As). Not more than 3 parts (1) Assay. The glycyrrhizin content of per million as determined by the meth- each flavoring ingredient shall be de- od in the Food Chemicals Codex. 3d Ed. termined by the method in the Official (1981), p. 464, which is incorporated by Methods of Analysis of the Association reference. of Official Analytical Chemists, 13th (c) In accordance with § 184.1(b)(2), Ed., §§ 19.136–19.140, which is incor- these ingredients are used in food only porated by reference, or by methods within the following specific limita- 19.CO1 through 19.CO4 in the Journal of tions:

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Maximum level in food (percent Category of food glycyrrhizin con- Functional use tent of food) (as served)

Baked foods, § 170.3(n)(1) of this chapter ...... 0 .05 Flavor enhancer, § 170.3(o)(11) of this chapter; flavoring agent, § 170.3(o)(12) of this chapter. Alcoholic beverages, § 170.3(n)(2) of this chapter ..... 0 .1 Flavor enhancer, § 170.3(o)(11) of this chapter; flavoring agent, § 170.3(o)(12) of this chapter; surface-active agent, § 170.3(o)(29) of this chapter. Nonalcoholic beverages, § 170.3(n)(3) of this chapter 0 .15 Do. Chewing gum, § 170.3(n)(6) of this chapter ...... 1 .1 Flavor enhancer, § 170.3(o)(11) of this chapter; flavoring agent, § 170.3(n)(12) of this chapter. Hard candy, § 170.3(n)(25) of this chapter ...... 16.0 Do. Herbs and seasonings, § 170.3(n)(26) of this chapter 0.15 Do. Plant protein products, § 170.3(n)(33) of this chapter 0 .15 Do. Soft candy, § 170.3(n)(38) of this chapter ...... 3 .1 Do. Vitamin or mineral dietary supplements ...... 0 .5 Do. All other foods except sugar substitutes, 0 .1 Do. § 170.3(n)(42) of this chapter. The ingredient is not permitted to be used as a nonnutritive sweetener in sugar substitutes.

(d) Prior sanctions for this ingredient § 184.1415 Animal lipase. different from the uses established in (a) Animal lipase (CAS Reg. No. 9001– this section do not exist or have been 62–1) is an enzyme preparation obtained waived. from edible forestomach tissue of [50 FR 21044, May 22, 1985, as amended at 54 calves, kids, or lambs, or from animal FR 24899, June 12, 1989] pancreatic tissue. The enzyme preparation may be produced as a tissue prepa- § 184.1409 Ground limestone. ration or as an aqueous extract. Its (a) Ground limestone consists essen- characterizing enzyme activity is that tially (not less than 94 percent) of cal- of a triacylglycerol hydrolase (EC cium carbonate (CaCO3) and is prepared 3.1.1.3). by the crushing, grinding, and (b) The ingredient meets the general classifying of naturally occurring lime- requirements and additional require- stone. ments for enzyme preparations in the (b) The ingredient meets the speci- Food Chemicals Codex, 3d ed. (1981), p. fications of the Food Chemicals Codex, 110, which is incorporated by reference 3d Ed. (1981), p. 173, which is incor- in accordance with 5 U.S.C. 552(a) and 1 porated by reference. Copies are avail- CFR part 51. Copies are available from able from the National Academy Press, the National Academy Press, 2101 Con- 2101 Constitution Ave. NW., Wash- stitution Ave., NW., Washington, DC ington, DC 20418, or available for in- 20418, or may be examined at the Office spection at the National Archives and of Premarket Approval (HFS–200), Food Records Administration (NARA). For and Drug Administration, 5100 Paint information on the availability of this Branch Pkwy., College Park, MD 20740, material at NARA, call 202–741–6030, or and at the National Archives and go to: http://www.archives.gov/ Records Administration (NARA). For federallregister/ information on the availability of this codeloflfederallregulations/ material at NARA, call 202–741–6030, or ibrllocations.html. go to: http://www.archives.gov/ (c) In accordance with § 184.1(b)(1), federallregister/ the ingredient is used in food with no codeloflfederallregulations/ limitation other than current good ibrllocations.html. manufacturing practice. (c) In accordance with § 184.1(b)(1), (d) Prior sanctions for this ingredient the ingredient is used in food with no different from the uses established in limitation other than current good this section do not exist or have been manufacturing practice. The affirma- waived. tion of this ingredient as GRAS as a di- [48 FR 52442, Nov. 18, 1983] rect food ingredient is based upon the

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following current good manufacturing chapter for the interesterification of practice conditions of use: fats and oils. (1) The ingredient is used as an en- (2) The ingredient is used in food at zyme as defined in § 170.3(o)(9) of this levels not to exceed current good man- chapter to hydrolyze fatty acid ufacturing practice. glycerides. [63 FR 24419, May 4, 1998] (2) The ingredient is used in food at levels not to exceed current good man- § 184.1425 Magnesium carbonate. ufacturing practice. (a) Magnesium carbonate (molecular [60 FR 32911, June 26, 1995] formula approximately (MgCO3)4·Mg(OH)2·5H2O, CAS Reg. No. § 184.1420 Lipase enzyme preparation 39409–82–0) is also known as magnesium derived from Rhizopus niveus. carbonate hydroxide. It is a white pow- (a) Lipase enzyme preparation con- der formed either by adding an alkaline tains lipase enzyme (CAS Reg. No. carbonate (such as sodium carbonate) 9001–62–1), which is obtained from the to a solution of magnesium sulfate or culture filtrate resulting from a pure by carbonation of a slurry of magne- culture fermentation of a nonpatho- sium hydroxide followed by boiling of genic and nontoxigenic strain of the resulting magnesium carbonate. Rhizopus niveus. The enzyme prepara- (b) The ingredient meets the speci- tion also contains diatomaceous earth fications of the Food Chemicals Codex, as a carrier. The characterizing activ- 3d Ed. (1981), p. 177, which is incor- ity of the enzyme, which catalyzes the porated by reference. Copies are avail- interesterification of fats and oils at able from the National Academy Press, the 1- and 3-positions of triglycerides, 2101 Constitution Ave. NW., Wash- is triacylglycerol lipase (EC 3.1.1.3). ington, DC 20418, or available for in- (b) The ingredient meets the general spection at the National Archives and requirements and additional require- Records Administration (NARA). For ments for enzyme preparations in the information on the availability of this monograph on Enzyme Preparations in material at NARA, call 202–741–6030, or the ‘‘Food Chemicals Codex,’’ 4th ed. go to: http://www.archives.gov/ (1996), pp. 133 and 134, which is incor- federallregister/ porated by reference in accordance codeloflfederallregulations/ with 5 U.S.C. 552(a) and 1 CFR part 51. ibrllocations.html. Copies are available from the National (c) In accordance with § 184.1(b)(1), Academy Press, 2101 Constitution Ave. the ingredient is used in food with no NW., Washington, DC 20418, or may be limitation other than current good examined at the Center for Food Safety manufacturing practice. The affirma- and Applied Nutrition’s Library, 5100 tion of this ingredient as generally rec- Paint Branch Pkwy., College Park, MD ognized as safe (GRAS) as a direct 20740, or at the National Archives and human food ingredient is based upon Records Administration (NARA). For the following current good manufac- information on the availability of this turing practice conditions of use: material at NARA, call 202–741–6030, or (1) The ingredient is used as an go to: http://www.archives.gov/ anticaking and free-flow agent as de- federallregister/ fined in § 170.3(o)(1) of this chapter; a codeloflfederallregulations/ flour treating agent as defined in ibrllocations.html. § 170.3(o)(13) of this chapter; a lubricant (c) In accordance with § 184.1(b)(1), and release agent as defined in the ingredient is used in food with no § 170.3(o)(18) of this chapter; a nutrient limitation other than current good supplement as defined in § 170.3(o)(20) of manufacturing practice. The affirma- this chapter; a pH control agent as de- tion of this ingredient as generally rec- fined in § 170.3(o)(23) of this chapter; a ognized as safe as a direct human food processing aid as defined in § 170.3(o)(24) ingredient is based upon the following of this chapter; and a synergist as de- current good manufacturing practice fined in § 170.3(o)(31) of this chapter. conditions of use: (2) The ingredient is used in foods at (1) The ingredient is used as an en- levels not to exceed current good man- zyme as defined in § 170.3(o)(9) of this ufacturing practice.

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(d) Prior sanctions for this ingredient this section do not exist or have been different from the uses established in waived. this section do not exist or have been [50 FR 13559, Apr. 5, 1985; 50 FR 16080, Apr. 24, waived. 1985] [50 FR 13558, Apr. 5, 1985; 50 FR 16080, Apr. 24, § 184.1428 Magnesium hydroxide. 1985] (a) Magnesium hydroxide (Mg(OH)2, § 184.1426 Magnesium chloride. CAS Reg. No. 1309–42–8) occurs natu- (a) Magnesium chloride (MgC1 ·6H O, rally as the colorless, crystalline min- 2 2 eral brucite. It is prepared as a white CAS Reg. No. 7786–30–3) is a colorless, precipitate by the addition of sodium deliquescent, crystalline material that hydroxide to a water soluble magne- occurs naturally as the mineral sium salt or by hydration of reactive bischofite. It is prepared by dissolving grades of magnesium oxide. magnesium oxide, hydroxide, or car- (b) The ingredient meets the speci- bonate in aqueous hydrochloric acid so- fications of the Food Chemicals Codex, lution and crystallizing out magnesium 3d Ed. (1981), p. 178, which is incor- chloride hexahydrate. porated by reference. Copies are avail- (b) The ingredient meets the speci- able from the National Academy Press, fications of the Food Chemicals Codex, 2101 Constitution Ave. NW., Wash- 3d Ed. (1981), p. 177, which is incor- ington, DC 20418, or available for in- porated by reference. Copies are avail- spection at the National Archives and able from the National Academy Press, Records Administration (NARA). For 2101 Constitution Ave. NW., Wash- information on the availability of this ington, DC 20418, or available for in- material at NARA, call 202–741–6030, or spection at the National Archives and go to: http://www.archives.gov/ Records Administration (NARA). For federallregister/ information on the availability of this codeloflfederallregulations/ material at NARA, call 202–741–6030, or ibrllocations.html. go to: http://www.archives.gov/ (c) In accordance with § 184.1(b)(1), federallregister/ the ingredient is used in food with no codeloflfederallregulations/ limitation other than current good manufacturing practice. The affirma- ibrllocations.html. tion of this ingredient as generally rec- (c) In accordance with § 184.1(b)(1), ognized as safe (GRAS) as a direct the ingredient is used in food with no human food ingredient is based upon limitation other than current good the following current good manufac- manufacturing practice. The affirma- turing practice conditions of use: tion of this ingredient as generally rec- (1) The ingredient is used as a nutri- ognized as safe (GRAS) as a direct ent supplement as defined in human food ingredient is based upon § 170.3(o)(20) of this chapter; a pH con- the following current good manufac- trol agent as defined in § 170.3(o)(23) of turing practice conditions of use: this chapter; and a processing aid as (1) The ingredient is used as a fla- defined in § 170.3(o)(24) of this chapter. voring agent and adjuvant as defined in (2) The ingredient is used in foods at § 170.3(o)(12) of this chapter and a nutri- levels not to exceed current good man- ent supplement as defined in ufacturing practice. § 170.3(o)(20) of this chapter. (d) Prior sanctions for this ingredient (2) The ingredient is used in foods at different from the uses established in levels not to exceed current good man- this section do not exist or have been ufacturing practice. The ingredient waived. also may be used in infant formula in [50 FR 13559, Apr. 5, 1985, as amended at 64 accordance with section 412(g) of the FR 405, Jan. 5, 1999] Federal Food, Drug, and Cosmetic Act (the act) or with regulations promul- § 184.1431 Magnesium oxide. gated under section 412(a)(2) of the act. (a) Magnesium oxide (MgO, CAS Reg. (d) Prior sanctions for this ingredient No. 1309–48–4) occurs naturally as the different from the uses established in colorless, crystalline mineral periclase.

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It is produced either as a bulky white this section do not exist or have been powder (light) or a relatively dense waived. white powder (heavy) by heating mag- [50 FR 13559, Apr. 5, 1985] nesium hydroxide or carbonate. Heat- ing these magnesium salts under mod- § 184.1434 Magnesium phosphate. ° ° erate conditions (400 to 900 C for a few (a) Magnesium phosphate includes hours) produces light magnesium both magnesium phosphate, dibasic, oxide. Heating the salts under more and magnesium phosphate, tribasic. ° rigorous conditions (1200 C for 12 Magnesium phosphate, dibasic hours) produces heavy magnesium (MgHPO4·3H2O, CAS Reg. No. 7782–0975– oxide. Light magnesium oxide is con- 094) occurs naturally as the white, verted to heavy magnesium oxide by crystalline mineral newberyite. It is sustained heating at high tempera- prepared commercially as a precipitate tures. formed by treating a solution of mag- (b) The ingredient meets the speci- nesium sulfate with disodium phos- fications of the Food Chemicals Codex, phate under controlled conditions. 3d Ed. (1981), p. 178, which is incor- Magnesium phosphate, tribasic porated by reference. Copies are avail- (Mg3(PO4)2·xH2O, CAS Reg. No. 7757–87– able from the National Academy Press, 1) may contain 4, 5, or 8 molecules of 2101 Constitution Ave. NW., Wash- water of hydration. It is produced as a ington, DC 20418, or available for in- precipitate from a solution of mag- spection at the National Archives and nesite with phosphoric acid. Records Administration (NARA). For (b) Magnesium phosphate, dibasic, information on the availability of this meets the specifications of the Food material at NARA, call 202–741–6030, or Chemicals Codex, 3d Ed. (1981), p. 179, go to: http://www.archives.gov/ which is incorporated by reference. federallregister/ Magnesium phosphate, tribasic, meets codeloflfederallregulations/ the specifications of the Food Chemi- ibrllocations.html. cals Codex, 3d Ed. (1981), p. 180, which is (c) In accordance with § 184.1(b)(1), incorporated by reference. Copies are the ingredient is used in food with no available from the National Academy limitation other than current good Press, 2101 Constitution Ave. NW., manufacturing practice. The affirma- Washington, DC 20418, or available for tion of this ingredient as generally rec- inspection at the National Archives ognized as safe (GRAS) as a direct and Records Administration (NARA). human food ingredient is based upon For information on the availability of the following current good manufac- this material at NARA, call 202–741– 6030, or go to: http://www.archives.gov/ turing practice conditions of use: federallregister/ (1) The ingredient is used as an codeloflfederallregulations/ anticaking and free-flow agent as de- ibrllocations.html. fined in § 170.3(o)(1) of this chapter; a (c) In accordance with § 184.1(b)(1), firming agent as defined in § 170.3(o)(10) the ingredient is used in food with no of this chapter; a lubricant and release limitation other than current good agent as defined in § 170.3(o)(18) of this manufacturing practice. The affirma- chapter; a nutrient supplement as de- tion of this ingredient as generally rec- fined in § 170.3(o)(20) of this chapter; ognized as safe (GRAS) as a direct and a pH control agent as defined in human food ingredient is based upon § 170.3(o)(23) of this chapter. the following current good manufac- (2) The ingredient is used in foods at turing practice conditions of use: levels not be exceed current good man- (1) The ingredient is used as a nutri- ufacturing practice. The ingredient ent supplement as defined in also may be used in infant formula in § 170.3(o)(20) of this chapter and a pH accordance with section 412(g) of the control agent as defined in § 170.3(o)(23) Federal Food, Drug, and Cosmetic Act of this chapter. (the act) or with regulations promul- (2) The ingredient is used in foods at gated under section 412(a)(2) of the act. levels not to exceed current good man- (d) Prior sanctions for this ingredient ufacturing practice. The ingredient different from the uses established in also may be used in infant formula in

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accordance with section 412(g) of the this section do not exist or have been Federal Food, Drug, and Cosmetic Act waived. (the act) or with regulations promul- [50 FR 13560, Apr. 5, 1985] gated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient § 184.1443 Magnesium sulfate. different from the uses established in (a) Magnesium sulfate (MgSO ·7H O, this section do not exist or have been 4 2 CAS Reg. No. 10034–99–8) occurs natu- waived. rally as the mineral epsomite. It is pre- [50 FR 13560, Apr. 5, 1985, as amended at 69 pared by neutralization of magnesium FR 24512, May 4, 2004] oxide, hydroxide, or carbonate with sulfuric acid and evaporating the solu- § 184.1440 Magnesium stearate. tion to crystallization. (a) Magnesium stearate (b) The ingredient meets the specifications of the Food Chemicals Codex, (Mg(C17H34COO)2, CAS Reg. No. 557–04– 0) is the magnesium salt of stearic 3d Ed. (1981), p. 183, which is incor- acid. It is produced as a white precipi- porated by reference. Copies are avail- tate by the addition of an aqueous so- able from the National Academy Press, lution of magnesium chloride to an 2101 Constitution Ave. NW., Wash- aqueous solution of sodium stearate de- ington, DC 20418, or available for in- rived from stearic acid that is obtained spection at the National Archives and from edible sources and that conforms Records Administration (NARA). For to the requirements of § 172.860(b)(2) of information on the availability of this this chapter. material at NARA, call 202–741–6030, or (b) The ingredient meets the speci- go to: http://www.archives.gov/ fications of the Food Chemicals Codex, federallregister/ 3d Ed. (1981), p. 182, which is incor- codeloflfederallregulations/ porated by reference. Copies are avail- ibrllocations.html. able from the National Academy Press, (c) In accordance with § 184.1(b)(1), 2101 Constitution Ave. NW., Wash- the ingredient is used in food with no ington, DC 20418, or available for in- limitation other than current good spection at the National Archives and manufacturing practice. The affirma- Records Administration (NARA). For tion of this ingredient as generally rec- information on the availability of this ognized as safe (GRAS) as a direct material at NARA, call 202–741–6030, or human food ingredient is based upon go to: http://www.archives.gov/ the following current good manufac- federallregister/ turing practice conditions of use: codeloflfederallregulations/ (1) The ingredient is used as a flavor ibrllocations.html. enhancer as defined in § 170.3(o)(11) of (c) In accordance with § 184.1(b)(1), this chapter; a nutrient supplement as the ingredient is used in food with no defined in § 170.3(o)(20) of this chapter; limitation other than current good and a processing aid as defined in manufacturing practice. The affirma- § 170.3(o)(24) of this chapter. tion of this ingredient as generally rec- (2) The ingredient is used in foods at ognized as safe (GRAS) as a direct levels not to exceed current good man- human food ingredient is based upon ufacturing practice. the following current good manufac- (d) Prior sanctions for this ingredient turing practice conditions of use: different from the uses established in (1) The ingredient is used as a lubri- this section do not exist or have been cant and release agent as defined in waived. § 170.3(o)(18) of this chapter; a nutrient [50 FR 13560, Apr. 5, 1985] supplement as defined in § 170.3(o)(20) of this chapter; and a processing aid as § 184.1443a Malt. defined in § 170.3(o)(24) of this chapter. (a) Malt is an enzyme preparation ob- (2) The ingredient is used in foods at tained from barley which has been soft- levels not to exceed current good man- ened by a series of steeping operations ufacturing practice. and germinated under controlled condi- (d) Prior sanctions for this ingredient tions. It is a brown, sweet, and viscous different from the uses established in liquid or a white to tan powder. Its

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characterizing enzyme activities are a- (1992), p. 125, which are incorporated by amylase (EC 3.2.1.1.) and b-amylase (EC reference in accordance with 5 U.S.C. 3.2.1.2). 552(a) and 1 CFR part 51. Copies are (b) The ingredient meets the general available from the National Academy requirements and additional require- Press, 2101 Constitution Ave., NW., ments for enzyme preparations in the Washington, DC 20418, or at the Divi- Food Chemicals Codex, 3d ed. (1981), p. sion of Petition Control (HFS–217), 110, which is incorporated by reference Center for Food Safety and Applied Nu- in accordance with 5 U.S.C. 552(a) and 1 trition, Food and Drug Administration, CFR part 51. Copies are available from 5100 Paint Branch Pkwy., College Park, the National Academy Press, 2101 Con- MD 20740, or may be examined at the stitution Ave., NW., Washington, DC National Archives and Records Admin- 20418, or may be examined at the Office istration (NARA). For information on of Premarket Approval (HFS–200), Food the availability of this material at and Drug Administration, 5100 Paint NARA, call 202–741–6030, or go to: http:// Branch Pkwy., College Park, MD 20740, www.archives.gov/federallregister/ and at the National Archives and codeloflfederallregulations/ Records Administration (NARA). For ibrllocations.html.. information on the availability of this (3) Maltodextrin derived from rice material at NARA, call 202–741–6030, or starch meets the specifications of the go to: http://www.archives.gov/ Food Chemicals Codex, 4th ed. (1996), federallregister/ pp. 239 and 240, which is incorporated codeloflfederallregulations/ by reference in accordance with 5 ibrllocations.html. U.S.C. 552(a) and 1 CFR part 51. Copies (c) In accordance with § 184.1(b)(1), are available from the National Acad- the ingredient is used in food with no emy Press, 2101 Constitution Ave. NW., limitation other than current good Washington, DC 20418, or may be exam- manufacturing practice. The affirma- ined at the Center for Food Safety and tion of this ingredient as GRAS as a di- Applied Nutrition’s Library, 5100 Paint rect food ingredient is based upon the Branch Pkwy., College Park, MD 20740, following current good manufacturing or at the National Archives and practice conditions of use: Records Administration (NARA). For (1) The ingredient is used as an en- information on the availability of this zyme as defined in § 170.3(o)(9) of this material at NARA, call 202–741–6030, or chapter to hydrolyze starch or starch- go to: http://www.archives.gov/ derived polysaccharides. federallregister/ (2) The ingredient is used in food at codeloflfederallregulations/ levels not to exceed current good man- ibrllocations.html. ufacturing practice. (c) In accordance with § 184.1(b)(1), [60 FR 32911, June 26, 1995] the ingredient is used in food with no limitation other than current good § 184.1444 Maltodextrin. manufacturing practice. (d) Prior sanctions for this ingredient (a) Maltodextrin ((C6H10O5)n, CAS Reg. No. 9050–36–6) is a nonsweet nutri- different from the uses established in tive saccharide polymer that consists this section do not exist or have been of D-glucose units linked primarily by waived. a-1-4 bonds and that has a dextrose [48 FR 51911, Nov. 15, 1983; as amended at 60 equivalent (D.E.) of less than 20. It is FR 48893, Sept. 21, 1995; 63 FR 14611, Mar. 26, prepared as a white powder or con- 1998] centrated solution by partial hydrolysis of corn starch, potato starch, or § 184.1445 Malt syrup (malt extract). rice starch with safe and suitable acids (a) Malt is the product of barley and enzymes. (Hordeum vulgare L.) germinated under (b)(1) Maltodextrin derived from corn controlled conditions. Malt syrup and starch must be of a purity suitable for malt extract are interchangeable terms its intended use. for a viscous concentrate of water ex- (2) Maltodextrin derived from potato tract of germinated barley grain, with starch meets the specifications of the or without added safe preservative. Food Chemicals Codex, 3d ed., 3d supp. Malt syrup is usually a brown, sweet,

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and viscous liquid containing varying federallregister/ amounts of amylolytic enzymes and codeloflfederallregulations/ plant constituents. Barley is first soft- ibrllocations.html. ened after cleaning by steeping oper- (c) In accordance with § 184.1(b)(1), ations and then allowed to germinate the ingredient is used in food with no under controlled conditions. The ger- limitation other than current good minated grain then undergoes proc- manufacturing practice. The affirma- essing, such as drying, grinding, ex- tion of this ingredient as generally rec- tracting, filtering, and evaporating, to ognized as safe (GRAS) as a direct produce malt syrup (malt extract) with human food ingredient is based upon 75 to 80 percent solids or dried malt the following current good manufac- syrup with higher solids content. turing practice conditions of use: (b) The ingredient must be of a pu- (1) The ingredient is used as a nutri- rity suitable for its intended use. ent supplement as defined in (c) In accordance with § 184.1(b)(1), § 170.3(o)(20) of this chapter. the ingredient is used in food with no (2) The ingredient may be used in in- limitation other than current good fant formulas in accordance with sec- manufacturing practice. The affirmation 412(g) of the Federal Food, Drug, tion of this ingredient as generally rec- and Cosmetic Act (the act) or with reg- ognized as safe (GRAS) as a direct ulations promulgated under section human food ingredient is based upon 412(a)(2) of the act. the following current good manufac- (d) Prior sanctions for this ingredient turing practice conditions of use: different from the uses established in (1) The ingredient is used as a fla- this section do not exist or have been voring agent and adjuvant as defined in waived. § 170.3(o)(12) of this chapter. [50 FR 19165, May 7, 1985] (2) The ingredient is used in food at levels not to exceed current good man- § 184.1449 Manganese citrate. ufacturing practice. (a) Manganese citrate (Mn (C H O ) , (d) Prior sanctions for this ingredient 3 6 5 7 2 CAS Reg. No. 1002–46–65) is a pale or- different from the uses established in ange or pinkish white powder. It is ob- this section do not exist or have been tained by precipitating manganese car- waived. bonate from manganese sulfate and so- [48 FR 51613, Nov. 10, 1983, as amended at 73 dium carbonate solutions. The filtered FR 8607, Feb. 14, 2008] and washed precipitate is digested first with sufficient citric acid solution to § 184.1446 Manganese chloride. form manganous citrate and then with (a) Manganese chloride (MnCl2·4H2O, sodium citrate to complete the reac- CAS Reg. No. 7773–01–5) is a pink, tion. translucent, crystalline product. It is (b) The ingredient must be of a pu- also known as manganese dichloride. It rity suitable for its intended use. is prepared by dissolving manganous (c) In accordance with § 184.1(b)(1), oxide, pyrolusite ore (MnO2), or re- the ingredient is used in food with no duced manganese ore in hydrochloric limitation other than current good acid. The resulting solution is neutral- manufacturing practice. The affirma- ized to precipitate heavy metals, fil- tion of this ingredient as generally rec- tered, concentrated, and crystallized. ognized as safe (GRAS) as a direct (b) The ingredient meets the speci- human food ingredient is based upon fications of the Food Chemicals Codex, the following current good manufac- 3d Ed. (1981), p. 186, which is incor- turing practice conditions of use: porated by reference. Copies are avail- (1) The ingredient is used as a nutri- able from the National Academy Press, ent supplement as defined in 2101 Constitution Ave. NW., Wash- § 170.3(o)(20) of this chapter. ington, DC 20418, or available for in- (2) The ingredient is used in the fol- spection at the National Archives and lowing foods at levels not to exceed Records Administration (NARA). For current good manufacturing practice: information on the availability of this baked goods as defined in § 170.3(n)(1) of material at NARA, call 202–741–6030, or this chapter; nonalcoholic beverages as go to: http://www.archives.gov/ defined in § 170.3(n)(3) of this chapter;

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dairy product analogs as defined in baked goods as defined in § 170.3(n)(1) of § 170.3(n)(10) of this chapter; fish prod- this chapter; nonalcoholic beverages as ucts as defined in § 170.3(n)(13) of this defined in § 170.3(n)(3) of this chapter; chapter; meat products as defined in dairy product analogs as defined in § 170.3(n)(29) of this chapter; milk prod- § 170.3(n)(10) of this chapter; fish products as defined in § 170.3(n)(31) of this ucts as defined in § 170.3(n)(13) of this chapter; and poultry products as de- chapter; meat products as defined in fined in § 170.3(n)(34) of this chapter. § 170.3(n)(29) of this chapter; milk prod- The ingredient may be used in infant ucts as defined in § 170.3(n)(31) of this formulas in accordance with section chapter; and poultry products as de- 412(g) of the Federal Food, Drug, and fined in § 170.3(n)(34) of this chapter. Cosmetic Act (the act) or with regula- The ingredient may be used in infant tions promulgated under section formulas in accordance with section 412(a)(2) of the act. 412(g) of the Federal Food, Drug, and (d) Prior sanctions for this ingredient Cosmetic Act (the act) or with regula- different from the uses established in tions promulgated under section this section do not exist or have been 412(a)(2) of the act. waived. (d) Prior sanctions for this ingredient different from the uses established in [50 FR 19166, May 7, 1985, as amended at 73 FR 8607, Feb. 14, 2008] this section do not exist or have been waived. § 184.1452 Manganese gluconate. [50 FR 19166, May 7, 1985] (a) Manganese gluconate (C12H22MnO14·2H2O, CAS Reg. No. 648– § 184.1461 Manganese sulfate. 0953–0998) is a slightly pink colored (a) Manganese sulfate (MnSO4·H2O, powder. It is obtained by reacting man- CAS Reg. No. 7785–0987–097) is a pale ganese carbonate with gluconic acid in pink, granular, odorless powder. It is aqueous medium and then crystallizing obtained by reacting manganese com- the product. pounds with sulfuric acid. It is also ob- (b) The ingredient meets the speci- tained as a byproduct in the manufac- fications of the Food Chemicals Codex, ture of hydroquinone. Other manufac- 3d Ed. (1981), p. 186, which is incor- turing processes include the action of porated by reference. Copies are avail- sulfur dioxide on a slurry of manganese able from the National Academy Press, dioxide in sulfuric acid, and the roast- 2101 Constitution Ave. NW., Wash- ing of pyrolusite (MnO2) ore with solid ington, DC 20418, or available for in- ferrous sulfate and coal, followed by spection at the National Archives and leaching and crystallization. Records Administration (NARA). For (b) The ingredient meets the speci- information on the availability of this fications of the Food Chemicals Codex, material at NARA, call 202–741–6030, or 3d Ed. (1981), p. 188, which is incor- go to: http://www.archives.gov/ porated by reference. Copies are avail- federallregister/ able from the National Academy Press, codeloflfederallregulations/ 2101 Constitution Ave. NW., Wash- ibrllocations.html. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(1), spection at the National Archives and the ingredient is used in food with no Records Administration (NARA). For limitation other than current good information on the availability of this manufacturing practice. The affirma- material at NARA, call 202–741–6030, or tion of this ingredient as generally rec- go to: http://www.archives.gov/ ognized as safe (GRAS) as a direct federallregister/ human food ingredient is based upon codeloflfederallregulations/ the following current good manufac- ibrllocations.html. turing practice conditions of use: (c) In accordance with § 184.1(b)(1), (1) The ingredient is used as a nutri- the ingredient is used in food with no ent supplement as defined in limitation other than current good § 170.3(o)(20) of this chapter. manufacturing practice. The affirma- (2) The ingredient is used in the fol- tion of this ingredient as generally rec- lowing foods at levels not to exceed ognized as safe (GRAS) as a direct current good manufacturing practice: human food ingredient is based upon

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the following current good manufac- ministration, 5100 Paint Branch Pkwy., turing practice conditions of use: College Park, MD 20740, or available for (1) The ingredient is used as a nutri- inspection at the Center for Food Safe- ent supplement as defined in ty and Applied Nutrition’s Library, § 170.3(o)(20) of this chapter. Food and Drug Administration, 5100 (2) The ingredient is used in the fol- Paint Branch Pkwy., College Park, MD lowing foods at levels not to exceed 20740, or at the National Archives and current good manufacturing practice: Records Administration (NARA). For baked goods as defined in § 170.3(n)(1) of information on the availability of this this chapter; nonalcoholic beverages as material at NARA, call 202–741–6030, or defined in § 170.3(n)(3) of this chapter; go to: http://www.archives.gov/ dairy product analogs as defined in federallregister/ § 170.3(n)(10) of this chapter; fish prod- codeloflfederallregulations/ ucts as defined in § 170.3(n(13) of this ibrllocations.html. chapter; meat products as defined in (iv) Iodine number. Not less than 120 § 170.3(n)(29) of this chapter; milk prod- as determined by the American Oil ucts as defined in § 170.3(n)(31) of this Chemists’ Society Recommended Prac- chapter; and poultry products as de- tice Cd 1d–92—‘‘Iodine Value of Fats fined in § 170.3(n)(34) of this chapter. and Oils, Cyclohexane—Acetic Acid The ingredient may be used in infant Method,’’ which is incorporated by ref- formulas in accordance with section erence in accordance with 5 U.S.C. 412(g) of the Federal Food, Drug, and 552(a) and 1 CFR part 51. The avail- Cosmetic Act (the act) or with regula- ability of this incorporation by ref- tions promulgated under section erence is given in paragraph (a)(2)(iii) 412(a)(2) of the act. of this section. (d) Prior sanctions for this ingredient (v) Unsaponifiable matter. Not more different from the uses established in than 1.5 percent as determined by the this section do not exist or have been American Oil Chemists’ Society Offi- waived. cial Method Ca 6b–53—‘‘Unsaponifiable Matter’’ (reapproved 1989), which is in- [50 FR 19166, May 7, 1985] corporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. § 184.1472 Menhaden oil. The availability of this incorporation (a) Menhaden oil. (1) Menhaden oil is by reference is given in paragraph prepared from fish of the genus (a)(2)(iii) of this section. Brevoortia, commonly known as menha- (vi) Free fatty acids. Not more than 0.1 den, by cooking and pressing. The re- percent as determined by the American sulting crude oil is then refined using Oil Chemists’ Society Official Method the following steps: Storage (winteriza- Ca 5a–40—‘‘Free Fatty Acids’’ (re- tion), degumming (optional), neutral- approved 1989), which is incorporated ization, bleaching, and deodorization. by reference in accordance with 5 Winterization may separate the oil and U.S.C. 552(a) and 1 CFR part 51. The produce a solid fraction. availability of this incorporation by (2) Menhaden oil meets the following reference is given in paragraph specifications: (a)(2)(iii) of this section. (i) Color and state. Yellow liquid to (vii) Peroxide value. Not more than 5 white solid. milliequivalents per kilogram of oil as (ii) Odor. Odorless to slightly fishy. determined by the American Oil Chem- (iii) Saponification value. Between 180 ists’ Society Official Method Cd 8–53— and 200 as determined by the American ‘‘Peroxide Value, Acetic Acid—Chloro- Oil Chemists’ Society Official Method form Method’’ (updated 1992) or Rec- Cd 3–25—‘‘Saponification Value’’ (re- ommended Practice Cd 8b–90—‘‘Per- approved 1989), which is incorporated oxide Value, Acetic Acid—Isooctane by reference in accordance with 5 Method’’ (updated 1992), which are in- U.S.C. 552(a) and 1 CFR part 51. Copies corporated by reference in accordance of this publication are available from with 5 U.S.C. 552(a) and 1 CFR part 51. the Office of Food Additive Safety, The availability of this incorporation Center for Food Safety and Applied Nu- by reference is given in paragraph trition (HFS–200), Food and Drug Ad- (a)(2)(iii) of this section.

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(viii) Lead. Not more than 0.1 part Maximum per million as determined by the Amer- level of use in Category of food food (as ican Oil Chemists’ Society Official served) Method Ca 18c–91—‘‘Determination of Nonalcoholic beverages, § 170.3(n)(3) of this 0.5 percent Lead by Direct Graphite Furnace chapter. Atomic Absorption Spectrometry’’ (re- Nut products, § 170.3(n)(32) of this chapter .. 5.0 percent vised 1992), which is incorporated by Pastas, § 170.3(n)(23) of this chapter ...... 2.0 percent reference in accordance with 5 U.S.C. Plant protein products, § 170.3(n)(33) of this 5.0 percent 552(a) and 1 CFR part 51. The avail- chapter. Poultry products, § 170.3(n)(34) of this chap- 3.0 percent ability of this incorporation by ref- ter. erence is given in paragraph (a)(2)(iii) Processed fruit juices, § 170.3(n)(35) of this 1.0 percent of this section. chapter. Processed vegetable juices, § 170.3(n)(36) 1.0 percent (ix) Mercury. Not more than 0.5 part of this chapter. per million as determined by the meth- Snack foods, § 170.3(n)(37) of this chapter .. 5.0 percent od entitled ‘‘Biomedical Test Materials Soft candy, § 170.3(n)(38) of this chapter ..... 4.0 percent Program: Analytical Methods for the Soup mixes, § 170.3(n)(40) of this chapter ... 3.0 percent Quality Assurance of Fish Oil,’’ pub- Sugar substitutes, § 170.3(n)(42) of this 10.0 percent chapter. lished in the ‘‘NOAA Technical Memo- Sweet sauces, toppings, syrups, 5.0 percent randum NMFS-SEFC-211,’’ F. M. Van § 170.3(n)(43) of this chapter. Dolah and S. B. Galloway, editors, Na- White granulated sugar, § 170.3(n)(41) of 4.0 percent tional Marine Fisheries Service, U. S. this chapter. Department of Commerce, pages 71–88, (4) To ensure safe use of the sub- November, 1988, which is incorporated stance, menhaden oil shall not be used by reference in accordance with 5 in combination with any other added U.S.C. 552(a) and 1 CFR part 51. The oil that is a significant source of availability of this incorporation by eicosapentaenoic acid or reference is given in paragraph docosahexaenoic acid. (a)(2)(iii) of this section. (b) Hydrogenated and partially hydro- (3) In accordance with § 184.1(b)(2), genated menhaden oils. (1) Partially hy- the ingredient may be used in food only drogenated and hydrogenated menha- within the following specific limita- den oils are prepared by feeding hydro- tions to ensure that total intake of gen gas under pressure to a converter eicosapentaenoic acid or containing crude menhaden oil and a docosahexaenoic acid does not exceed nickel catalyst. The reaction is begun 3.0 grams/person/day: at 150 to 160 °C and after 1 hour the Maximum temperature is raised to 180 °C until level of use in the desired degree of hydrogenation is Category of food food (as served) reached. Hydrogenated menhaden oil is fully hydrogenated. Baked goods, baking mixes, § 170.3(n)(1) of 5.0 percent this chapter. (2) Partially hydrogenated and hy- Cereals, § 170.3(n)(4) of this chapter ...... 4.0 percent drogenated menhaden oils meet the fol- Cheese products, § 170.3(n)(5) of this chap- 5.0 percent lowing specifications: ter. (i) Color. Opaque white solid. Chewing gum, § 170.3(n)(6) of this chapter .. 3.0 percent Condiments, § 170.3(n)(8) of this chapter ..... 5.0 percent (ii) Odor. Odorless. Confections, frostings, § 170.3(n)(9) of this 5.0 percent (iii) Saponification value. Between 180 chapter. and 200. Dairy product analogs, § 170.3(n)(10) of this 5.0 percent chapter. (iv) Iodine number. Not more than 119 Egg products, § 170.3(n)(11) of this chapter 5.0 percent for partially hydrogenated menhaden Fats, oils, § 170.3(n)(12) of this chapter, but 12.0 percent oil and not more than 10 for fully hy- not in infant formula. Fish products, § 170.3(n)(13) of this chapter 5.0 percent drogenated menhaden oil. Frozen dairy desserts, § 170.3(n)(20) of this 5.0 percent (v) Unsaponifiable matter. Not more chapter. than 1.5 percent.— Gelatins, puddings, § 170.3(n)(22) of this 1.0 percent (vi) Free fatty acids. Not more than 0.1 chapter. Gravies, sauces, § 170.3(n)(24) of this chap- 5.0 percent percent. ter. (vii) Peroxide value. Not more than 5 Hard candy, § 170.3(n)(25) of this chapter .... 10.0 percent milliequivalents per kilogram of oil. Jams, jellies, § 170.3(n)(28) of this chapter .. 7.0 percent Meat products, § 170.3(n)(29) of this chapter 5.0 percent (viii) Nickel. Not more than 0.5 part Milk products, § 170.3(n)(31) of this chapter 5.0 percent per million.

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(ix) Mercury. Not more than 0.5 part this regulation do not exist or have per million. been waived. (x) Arsenic (as As). Not more than 0.1 [42 FR 14653, Mar. 15, 1977, as amended at 49 part per million. FR 5612, Feb. 14, 1984] (xi) Lead. Not more than 0.1 part per million. § 184.1498 Microparticulated protein (3) Partially hydrogenated and hy- product. drogenated menhaden oils are used as (a) Microparticulated protein product edible fats or oils, as defined in is prepared from egg whites or milk § 170.3(n)(12) of this chapter, in food at protein or a combination of egg whites levels not to exceed current good man- and milk protein. These protein ufacturing practice. sources may be used alone or in com- (4) If the fat or oil is fully hydro- bination with other safe and suitable genated, the name to be used on the ingredients to form the label of a product containing it shall microparticulated product. The mix- include the term ‘‘hydrogenated,’’ or if ture of ingredients is high-shear heat processed to achieve a smooth and it is partially hydrogenated, the name creamy texture similar to that of fat. shall include the term ‘‘partially hy- Safe and suitable ingredients used in drogenated,’’ in accordance with the preparation of the § 101.4(b)(14) of this chapter. microparticulated protein product [62 FR 30756, June 5, 1997, as amended at 70 must be used in compliance with the FR 14531, Mar. 23, 2005] limitations of the appropriate regulations in parts 172, 182, and 184 of this § 184.1490 Methylparaben. chapter. (a) Methylparaben is the chemical (b) The ingredient is used in food in methyl p-hydroxybenzoate. It is pro- accordance with § 184.1(b)(2) at levels duced by the methanol esterification of not to exceed current good manufacturing practice. The affirmation of the p-hydroxybenzoic acid in the presence use of this ingredient as generally rec- of sulfuric acid, with subsequent dis- ognized as safe (GRAS) as a direct tillation. human food ingredient is based upon (b) The ingredient meets the speci- the following conditions of use: fications of the ‘‘Food Chemicals (1) The ingredient is used in food as a Codex,’’ 3d Ed. (1981), p. 199, which is in- thickener as defined in § 170.3(o)(28) of corporated by reference. Copies may be this chapter or as a texturizer as de- obtained from the National Academy fined in § 170.3(o)(32) of this chapter. Press, 2101 Constitution Ave. NW., (2) The ingredient is used in frozen Washington, DC 20418, or may be exam- dessert-type products except that the ined at the National Archives and ingredient may not be used to replace Records Administration (NARA). For the milk fat required in standardized information on the availability of this frozen desserts. material at NARA, call 202–741–6030, or (3) The name of the ingredient used go to: http://www.archives.gov/ in the ingredient statement on both federallregister/ bulk and packaged food must include codeloflfederallregulations/ the source of the protein (e.g., ibrllocations.html. ‘‘microparticulated egg white pro- (c) The ingredient is used as an anti- tein’’), followed by a parenthetical list- microbial agent as defined in ing of each of the ingredients in the § 170.3(o)(2) of this chapter. microparticulated protein product, in (d) The ingredient is used in food at descending order of predominance. Microparticulated protein product levels not to exceed good manufac- must be used in accordance with this turing practices. Current good manu- requirement or its addition to food will facturing practice results in a max- be considered by FDA to constitute the imum level of 0.1 percent in food. use of an unapproved food additive (see (e) Prior sanctions for this ingredient § 184.1(b)(2)). different from the uses established in [55 FR 6391, Feb. 23, 1990]

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§ 184.1505 Mono- and diglycerides. agent as defined in § 170.3(o)(30) of this (a) Mono- and diglycerides consist of chapter; and a texturizer as defined in a mixture of glyceryl mono- and § 170.3(o)(32) of this chapter. diesters, and minor amounts of (2) The ingredient is used in food at triesters, that are prepared from fats levels not to exceed current good man- or oils or fat-forming acids that are de- ufacturing practice. rived from edible sources. The most (d) Prior sanctions for this ingredient prevalent fatty acids include lauric, different from the uses established in linoleic, myristic, oleic, palmitic, and this section do not exist or have been stearic. Mono- and diglycerides are waived. manufactured by the reaction of glyc- [54 FR 7403, Feb. 21, 1989, as amended at 57 erin with fatty acids or the reaction of FR 10616, Mar.27, 1992] glycerin with triglycerides in the presence of an alkaline catalyst. The prod- § 184.1521 Monosodium phosphate de- ucts are further purified to obtain a rivatives of mono- and diglycerides. mixture of glycerides, free fatty acids, (a) Monosodium phophate derivatives and free glycerin that contains at least of mono- and diglycerides are com- 90 percent-by-weight glycerides. posed of glyceride derivatives formed (b) The ingredient meets the speci- by reacting mono- and diglycerides fications of the Food Chemicals Codex, that are derived from edible sources 3d Ed. (1981), p. 201, which is incor- with phosphorus pentoxide porated by reference in accordance (tetraphosphorus decoxide) followed by with 5 U.S.C. 552(a). Copies are avail- neutralization with sodium carbonate. able from the National Academy Press, (b) The ingredient must be of a pu- 2101 Constitution Ave. NW., Wash- rity suitable for its intended use. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(1), spection at the National Archives and the ingredient is used in food with no Records Administration (NARA). For limitation other than current good information on the availability of this manufacturing practice. The affirma- material at NARA, call 202–741–6030, or tion of this ingredient as generally rec- go to: http://www.archives.gov/ ognized as safe (GRAS) as a direct federallregister/ human food ingredient is based upon codeloflfederallregulations/ the following current good manufac- ibrllocations.html. turing practice conditions of use: (c) In accordance with § 184.1(b)(1), (1) The ingredient is used in food as the ingredient is used in food with no an emulsifier and emulsifier salt as de- limitation other than current good fined in § 170.3(o)(8) of this chapter, a manufacturing practice. The affirma- lubricant and release agent as defined tion of this ingredient as generally rec- in § 170.3(o)(18) of this chapter, and as a ognized as safe (GRAS) as a direct surface-active agent as defined in human food ingredient is based upon § 170.3(o)(29) of this chapter. the following current good manufac- (2) The ingredient is used in the fol- turing practice conditions of use: lowing foods at levels not to exceed (1) The ingredient is used in food as a current good manufacturing practice: dough strengthener as defined in dairy product analogs as defined in § 170.3(o)(6) of this chapter; an emulsi- § 170.3(n)(10) of this chapter and soft fier and emulsifier salt as defined in candy as defined in § 170.3(n)(38) of this § 170.3(o)(8) of this chapter; a flavoring chapter. agent and adjuvant as defined in (d) Prior sanctions for this ingredient § 170.3(o)(12) of this chapter; a formula- different from the uses established in tion aid as defined in § 170.3(o)(14) of this section do not exist or have been this chapter; a lubricant and release waived. agent as defined in § 170.3(o)(18) of this chapter; a solvent and vehicle as de- [54 FR 7404, Feb. 21, 1989, as amended at 73 fined in § 170.3(o)(27) of this chapter; a FR 8607, Feb. 14, 2008] stabilizer and thickener as defined in § 170.3(o)(28) of this chapter; a surface- § 184.1530 Niacin. active agent as defined in § 170.3(o)(29) (a) Niacin (C6H5NO2, CAS Reg. No. 59– of this chapter; a surface-finishing 67–6) is the chemical 3-

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pyridinecarboxylic acid (nicotinic amide). It is a white crystalline powder acid). It is a non-hygroscopic, stable, that is soluble in water, alcohol, ether, white, crystalline solid that sublimes and glycerol. It melts between 128° and without decomposition at about 230 °C. 131 °C. It is soluble in water and alcohol. It is (b) The ingredient meets the speci- insoluble in ether. fications of the Food Chemicals Codex, (b) The ingredient meets the speci- 3d Ed. (1981), p. 205, which is incor- fications of the ‘‘Food Chemicals porated by reference. Copies are avail- Codex,’’ 4th ed. (1996), p. 264, which is able from the National Academy Press, incorporated by reference in accord- 2101 Constitution Ave. NW., Wash- ance with 5 U.S.C. 552(a) and 1 CFR ington, DC 20418, or available for in- part 51. Copies are available from the spection at the National Archives and National Academy Press, Box 285, 2101 Records Administration (NARA). For Constitution Ave. NW., Washington, information on the availability of this DC 20055 (Internet address http:// material at NARA, call 202–741–6030, or www.nap.edu), or may be examined at go to: http://www.archives.gov/ the Center for Food Safety and Applied federallregister/ Nutrition’s Library, Food and Drug Ad- codeloflfederallregulations/ ministration, 5100 Paint Branch Pkwy., ibrllocations.html. College Park, MD 20740, or at the Na- (c) In accordance with § 184.1(b)(1), tional Archives and Records Adminis- the ingredient is used in food with no tration (NARA). For information on limitation other than current good the availability of this material at manufacturing practice. The affirma- NARA, call 202–741–6030, or go to: http:// tion of this ingredient as generally rec- www.archives.gov/federallregister/ ognized as safe (GRAS) as a direct codeloflfederallregulations/ human food ingredient is based upon ibrllocations.html. the following current good manufac- (c) In accordance with § 184.1(b)(1), turing practice conditions of use: the ingredient is used in food with no (1) The ingredient is used as a nutri- limitation other than current good ent supplement as defined in manufacturing practice. The affirma- § 170.3(o)(20) of this chapter. tion of this ingredient as generally rec- (2) The ingredient is used in foods at ognized as safe (GRAS) as direct levels not to exceed current good man- human food ingredient is based upon ufacturing practice. The ingredient the following current good manufac- may also be used in infant formula in turing practice conditions of use: accordance with section 412(g) of the (1) The ingredient is used as a nutri- Federal Food, Drug, and Cosmetic Act ent supplement as defined in (the act) or with regulations promul- § 170.3(o)(20) of this chapter. gated under section 412(a)(2) of the Act. (2) The ingredient is used in foods at (d) Prior sanctions for this ingredient levels not to exceed current good man- different from the uses established in ufacturing practice. The ingredient this section do not exist or have been may also be used in infant formula in waived. accordance with section 412(g) of the [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. Federal Food, Drug, and Cosmetic Act 2, 1983] (the Act) or with regulations promulgated under section 412(a)(2) of the Act. § 184.1537 Nickel. (d) Prior sanctions for this ingredient (a) Elemental nickel (CAS Reg. No. different from the uses established in 7440–02–0) is obtained from nickel ore this section do not exist or have been by transforming it to nickel sulfide waived. (Ni3S2). The sulfide is roasted in air to [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. give nickel oxide (NiO). The oxide is 2, 1983, as amended at 64 FR 1760, Jan. 12, then reduced with carbon to give ele- 1999] mental nickel. (b) The ingredient must be of a pu- § 184.1535 Niacinamide. rity suitable for its intended use. (a) Niacinamide (C6H6N2O, CAS Reg. (c) In accordance with § 184.1(b)(1), No. 98–92–0) is the chemical 3- the ingredient is used in food with no pyridinecarboxylic acid amide (nicotin- limitation other than current good

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manufacturing practice. The affirma- (4) Zinc, not more than 25 parts per tion of this ingredient as generally rec- million. ognized as safe (GRAS) as a direct (5) Copper, zinc plus copper not more human food ingredient is based upon than 50 parts per million. the following current good manufac- (6) Total plate count, not more than turing practice conditions of use: 10 per gram. (1) The ingredient is used as a cata- (7) Escherichia coli, absent in 10 lyst as defined in § 170.3(o)(24) of this grams. chapter. (2) The ingredient is used in the hy- (8) Salmonella, absent in 10 grams. drogenation of fats and oils as defined (9) Coagulase positive staphylococci, in § 170.3(n)(12) of this chapter at levels absent in 10 grams. not to exceed current good manufac- (c) The ingredient is used as an anti- turing practice. Current good manufac- microbial agent as defined in turing practice includes the removal of § 170.3(o)(2) of this chapter to inhibit nickel from fats and oils following hy- the outgrowth of Clostridium botulinum drogenation. spores and toxin formation in pasteur- (d) Prior sanctions for this ingredient ized cheese spreads and pasteurized different from the uses established in process cheese spreads listed in this section do not exist or have been § 133.175; pasteurized cheese spread with waived. fruits, vegetables, or meats as defined [48 FR 51618, Nov. 10, 1983, as amended at 73 in § 133.176; pasteurized process cheese FR 8607, Feb. 14, 2008] spread as defined in § 133.179; pasteurized process cheese spread with fruits, § 184.1538 Nisin preparation. vegetables, or meats as defined in (a) Nisin preparation is derived from § 133.180 of this chapter. pure culture fermentations of certain (d) The ingredient is used at levels strains of Streptococcus lactis not to exceed good manufacturing Lancefield Group N. Nisin preparation practice in accordance with § 184.1(b)(1) contains nisin (CAS Reg. No. 1414–45–5), of this chapter. The current good man- a group of related peptides with anti- ufacturing practice level is the quan- biotic activity. tity of the ingredient that delivers a (b) The ingredient is a concentrate or maximum of 250 parts per million of dry material that meets the specifica- nisin in the finished product as deter- tions that follow when it is tested as mined by the British Standards Insti- described in ‘‘Specifications for Iden- tution Methods, ‘‘Methods for the Esti- tity and Purity of Some Antibiotics,’’ mation and Differentiation of Nisin in World Health Organization, FAO Nutri- Processed Cheese,’’ BS 4020 (1974), tion Meeting Report Series, No. 45A, which is incorporated by reference. 1969, which is incorporated by ref- Copies are available from the Division erence. Copies are available from the of Dockets Management (HFA–305), Division of Dockets Management Food and Drug Administration, rm. 1– (HFA–305), Food and Drug Administra- 23, 12420 Parklawn Dr., Rockville, MD tion, 5630 Fishers Lane, rm. 1061, Rock- 20857, or available for inspection at the ville, MD 20852, or available for inspec- National Archives and Records Admin- tion at the National Archives and istration (NARA). For information on Records Administration (NARA). For the availability of this material at information on the availability of this NARA, call 202–741–6030, or go to: http:// material at NARA, call 202–741–6030, or www.archives.gov/federallregister/ go to: http://www.archives.gov/ codeloflfederallregulations/ federallregister/ ibrllocations.html. codeloflfederallregulations/ ibrllocations.html. [53 FR 11250, Apr. 6, 1988, as amended at 59 (1) Nisin content, not less than 900 FR 14364, Mar. 28, 1994; 68 FR 24879, May 9, international units per milligram. 2003] (2) Arsenic, not more than 1 part per million. § 184.1540 Nitrogen. (3) Lead, not more than 2 parts per (a) Nitrogen (empirical formula N2, million. CAS Reg. No. 7727–37–9) is a colorless,

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odorless, flavorless gas that is pro- (d) Prior sanctions for this ingredient duced commercially by the fraction- different from the uses established in ation of liquid air. this section do not exist or have been (b) The ingredient must be of a pu- waived. rity suitable for its intended use. (c) In accordance with § 184.1(b)(1), [48 FR 57270, Dec. 29, 1983, as amended at 73 FR 8607, Feb. 14, 2008] the ingredient is used in food with no limitations other than current good § 184.1553 Peptones. manufacturing practice. The affirmation of this ingredient as generally rec- (a) Peptones are a variable mixture ognized as safe (GRAS) as a direct of polypeptides, oligopeptides, and human food ingredient is based upon amino acids that are produced by par- the following current good manufac- tial hydrolysis of casein, animal tissue, turing practice conditions of use: soy protein isolate, gelatin, defatted (1) The ingredient is used as a propel- fatty tissue, egg albumin, or lactal- lant, aerating agent, and gas as defined bumin (whey protein). Peptones are in § 170.3(o)(25) of this chapter. produced from these proteins using (2) The ingredient is used in food at proteolytic enzymes that either are levels not to exceed current good man- considered to be generally recognized ufacturing practice. as safe (GRAS) or are regulated as food (d) Prior sanctions for this ingredient additives. Peptones are also produced different from the uses established in by denaturing any of the proteins list- this section do not exist or have been ed in this paragraph with safe and suit- waived. able acids or heat. (b) The ingredients must be of a pu- [48 FR 57270, Dec. 29, 1983, as amended at 73 rity suitable for their intended use. FR 8607, Feb. 14, 2008] (c) In accordance with § 184.1(b)(1), § 184.1545 Nitrous oxide. these ingredients are used in food with no limitation other than current good (a) Nitrous oxide (empirical formula manufacturing practice. The affirma- N O, CAS Reg. No. 10024–97–2) is also 2 tion of these ingredients as GRAS as known as dinitrogen monoxide or direct human food ingredients is based laughing gas. It is a colorless gas, upon the following current good manu- about 50 percent heavier than air, with facturing practice conditions of use: a slightly sweet smell. It does not burn (1) These ingredients are used as nu- but will support combustion. Nitrous trient supplements as defined in oxide is manufactured by the thermal § 170.3(o)(20) of this chapter; as proc- decomposition of ammonium nitrate. essing aids as defined in § 170.3(o)(24) of Higher oxides of nitrogen are removed this chapter; and as surface-active by passing the dry gas through a series agents as defined in § 170.3(o)(29) of this of scrubbing towers. chapter. (b) The ingredient must be of a pu- (2) These ingredients are used in food rity suitable for its intended use. at levels not to exceed current good (c) In accordance with § 184.1(b)(1), manufacturing practice. the ingredient is used in food with no limitations other than current good (d) Prior sanctions for these ingredi- manufacturing practice. The affirma- ents different from the uses established tion of this ingredient as generally rec- in this section do not exist or have ognized as safe (GRAS) as a direct been waived. human food ingredient is based upon [49 FR 25430, June 21, 1984, as amended at 50 the following current good manufac- FR 49536, Dec. 3, 1985; 73 FR 8607, Feb. 14, turing practice conditions of use: 2008] (1) The ingredient is used as a propellant, aerating agent, and gas as defined § 184.1555 Rapeseed oil. in § 170.3(o)(25) of this chapter. (a) Fully hydrogenated rapeseed oil. (1) (2) The ingredient is used in dairy Fully hydrogenated rapeseed oil is a product analogs as defined in mixture of triglycerides in which the § 170.3(n)(10) of this chapter at levels fatty acid composition is a mixture of not to exceed current good manufac- saturated fatty acids. The fatty acids turing practice. are present in the same porportions

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which result from the full hydro- ibrllocations.html. An additional speci- genation of fatty acids occurring in fication requires the iodine number to natural rapeseed oil. The rapeseed oil be 4 or less. is obtained from the napus and (3) The ingredient is used as an emul- campestris varieties of Brassica of the sifier as defined in § 170.3(o)(8) of this family Cruciferae. It is prepared by chapter in shortenings for cake mixes. fully hydrogenating refined and The use level of the ingredient is lim- ° bleached rapeseed oil at 310–375 F, ited by good manufacturing practice using a catalyst such as nickel, until (GMP) to the minimum amount re- the iodine number is 4 or less. quired to produce the intended effect. (2) The ingredient meets the fol- Current good manufacturing practices lowing specifications: Acid value not result in a maximum level, as served, more than 6, arsenic not more than 3 parts per million, free glycerin not of 4 percent of the shortening or 0.5 more than 7 percent, heavy metals (as percent of the total weight of the cake Pb) not more than 10 parts per million, mix. iodine number not more than 4, residue (c) Low erucic acid rapeseed oil. (1) on ignition not more than 0.5 percent. Low erucic acid rapeseed oil, also (3) The ingredient is used as a sta- known as canola oil, is the fully re- bilizer and thickener as defined in fined, bleached, and deodorized edible § 170.3(o)(28) of this chapter in peanut oil obtained from certain varieties of butter. The use level of the ingredient Brassica Napus or B. Campestris of the is limited by good manufacturing prac- family Cruciferae. The plant varieties tice (GMP) to the minimum amount re- are those producing oil-bearing seeds quired to produce the intended effect. with a low erucic acid content. Chemi- Current good manufacturing practices cally, low erucic acid rapeseed oil is a result in a maximum level of 2 percent mixture of triglycerides, composed of in peanut butter. both saturated and unsaturated fatty (b) Superglycerinated fully hydro- acids, with an erucic acid content of no genated rapeseed oil. (1) more than 2 percent of the component Superglycerinated fully hydrogenated fatty acids. rapeseed oil is a mixture of mono- and (2) Low erucic acid rapeseed oil as de- diglycerides with triglycerides as a fined in paragraph (c)(1) of this section minor component. The fatty acid com- may be partially hydrogenated to re- position is a mixture of saturated fatty acids present in the same proportions duce the proportion of unsaturated as those resulting from the full hydro- fatty acids. When the partially hydrogenation of fatty acids in natural genated low erucic acid rapeseed oil is rapeseed oil. It is made by adding ex- used, it shall be referred to as partially cess glycerol to the fully hydrogenated hydrogenated low erucic acid rapeseed rapeseed oil and heating, in the pres- oil. ence of a sodium hydroxide catalyst, to (3) In addition to limiting the con- 330 °F under partial vacuum and steam tent of erucic acid to a level not ex- sparging agitation. ceeding 2 percent of the component (2) The ingredient meets the speci- fatty acids, low erucic acid rapeseed oil fications of the ‘‘Food Chemicals and partially hydrogenated low erucic Codex,’’ 3d Ed. (1981), p. 201, relating to acid rapeseed oil must be of a purity mono- and diglycerides, which is incor- suitable for their intended use. porated by reference. Copies may be (4) Low erucic acid rapeseed oil and obtained from the National Academy partially hydrogenated low erucic acid Press, 2101 Constitution Ave. NW., rapeseed oil are used as edible fats and Washington, DC 20418, or may be exam- oils in food, except in infant formula, ined at the National Archives and at levels not to exceed current good Records Administration (NARA). For manufacturing practice. information on the availability of this material at NARA, call 202–741–6030, or [42 FR 48336, Sept. 23, 1977, as amended at 49 go to: http://www.archives.gov/ FR 5613, Feb. 14, 1984; 50 FR 3755, Jan. 28, federallregister/ 1985; 53 FR 52682, Dec. 29, 1988; 73 FR 8608, codeloflfederallregulations/ Feb. 14, 2008]

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§ 184.1560 Ox bile extract. Maximum treat- Category of food ment level in food Functional use (a) Ox bile extract (CAS Reg. No. 8008–63–7), also known as purified Bottled water that Not to exceed cur- Antimicrobial prior to ozonation rent good man- agent, § 170.3 oxgall or sodium choleate, is a yel- meets the micro- ufacturing prac- (o)(2) of this lowish green, soft solid, with a partly biological, phys- tice. Current chapter. sweet, partly bitter, disagreeable taste. ical, chemical, good manufac- and radiological turing practice It is the purified portion of the bile of quality standards results in a an ox obtained by evaporating the alco- of § 165.110 maximum resid- hol extract of concentrated bile. (b)(2) through ual level at the (b)(5) of this time of bottling (b) Food-grade ox bile extract shall chapter. of 0.4 milligram meet the specifications of the U.S. of ozone per Pharmacopeia (USP), XIV, 1950, p. 410. 1 liter of bottled water. (c) The ingredient is used as a surfac- tant as defined in § 170.3 (o)(29) of this [47 FR 50210, Nov. 5, 1982, as amended at 60 chapter. FR 57130, Nov. 13, 1995] (d) The ingredient is used in food in accordance with § 184.1(b)(1) at levels § 184.1583 Pancreatin. not to exceed good manufacturing (a) Pancreatin (CAS Reg. No. 8049–47– practice. Current good manufacturing 6) is an enzyme preparation obtained practice results in a maximum level, as from porcine or bovine pancreatic tis- served, of 0.002 percent for cheese as de- sue. It is a white to tan powder. Its fined in § 170.3(n)(5) of this chapter. characterizing enzyme activity that of (e) Prior sanctions for this ingredient a peptide hydrolase (EC 3.4.21.36). different from the uses established in (b) The ingredient meets the general this section do not exist or have been requirements and additional require- waived. ments in the Food Chemicals Codex, 3d [43 FR 36064, Aug. 15, 1978. Redesignated and ed. (1981), p. 110, which is incorporated amended at 50 FR 49537, Dec. 3, 1985] by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies § 184.1563 Ozone. are available from the National Acad- (a) Ozone (O3, CAS Reg. No. 10028–15– emy Press, 2101 Constitution Ave. NW., 6) is an unstable blue gas with a pun- Washington, DC 20418, or may be exam- gent, characteristic odor, which occurs ined at the Office of Premarket Ap- freely in nature, It is produced com- proval (HFS–200), Food and Drug Ad- mercially by passing electrical dis- ministration, 5100 Paint Branch Pkwy., charges or ionizing radiation through College Park, MD 20740, and at the Na- air or oxygen. tional Archives and Records Adminis- (b) The ingredient must be of a pu- tration (NARA). For information on rity suitable for its intended use in ac- the availability of this material at cordance with § 170.30(h)(1) of this chap- NARA, call 202–741–6030, or go to: http:// ter. www.archives.gov/federallregister/ (c) In accordance with § 184.1(b)(2), codeloflfederallregulations/ the ingredient is used to treat food ibrllocations.html. only within the following specific limi- (c) In accordance with § 184.1(b)(1), tations: the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme as defined in § 170.3(o)(9) of this 1 Copies may be obtained from: U.S. Pharmacopeial Convention, Inc., 12601 chapter to hydrolyze proteins or Twinbrook Parkway, Rockville, MD 20852. polypeptides.

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(2) The ingredient is used in food at § 184.1588 Pectins. levels not to exceed current good man- (a) The pectins (CAS Reg. No. 9000– ufacturing practice. 69–5) are a group of complex, high mo- [60 FR 32911, June 26, 1995] lecular weight polysaccharides found in plants and composed chiefly of par- § 184.1585 Papain. tially methylated polygalacturonic acid units. Portions of the carboxly (a) Papain (CAS Reg. No. 9001–73–4) is group occur as methyl esters, and the a proteolytic enzyme derived from remaining carboxyl groups exist in the Carica papaya L. Crude latex conform of the free acid or as its ammo- taining the enzyme is collected from nium, potassium, or sodium (CAS Reg. slashed unripe papaya. The food-grade No. 9000–59–8) salts, and in some types product is obtained by repeated filtra- as the acid amide. Thus, the pectins tion of the crude latex or an aqueous regulated in this section are the high- solution of latex or by precipitation ester pectins, low-ester pectins, from an aqueous solution of latex. The amidated pectins, pectinic acids, and resulting enzyme preparation may be pectinates. Pectin is produced commer- used in a liquid or dry form. cially by extracting citrus peel, apple (b) The ingredient meets the speci- pomace, or beet pulp with hot dilute fications of the Food Chemicals Codex, acid (pH 1.0 to 3.5, 70° to 90 °C). The ex- 3d Ed. (1981), pp. 107–110, which is incor- tract is filtered, and pectin is then pre- porated by reference. Copies are avail- cipitated from the clear extract with able from the National Academy Press, ethanol or isopropanol, or as the copper or aluminum salt. The acid extract 2101 Constitution Ave. NW., Wash- is sometimes spray- or roller-dried, or ington, DC 20418, or available for in- it is concentrated to be sold as liquid spection at the National Archives and pectin. Records Administration (NARA). For (b) The ingredients meet the speci- information on the availability of this fications of the Food Chemical Codex, material at NARA, call 202–741–6030, or 3d Ed. (1981), p. 215, which is incor- go to: http://www.archives.gov/ porated by reference. Copies are avail- federallregister/ able from the National Academy Press, codeloflfederallregulations/ 2101 Constitution Ave. NW., Wash- ibrllocations.html. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(1), spection at the National Archives and the ingredient is used in food with no Records Administration (NARA). For limitation other than currect good information on the availability of this manufacturing practice. The affirma- material at NARA, call 202–741–6030, or tion of this ingredient as generally rec- go to: http://www.archives.gov/ ognized as safe (GRAS) as a direct federallregister/ human food ingredient is based upon codeloflfederallregulations/ the following current good manufac- ibrllocations.html. (c) In accordance with § 184.1(b)(1), turing conditions of use: the ingredients are used in food with (1) The ingredient is used as an en- no limitation other than current good zyme as defined in § 170.3(o)(9) of this manufacturing practice. The affirma- chapter; processing aid as defined in tion of these ingredients as generally § 170.3(o)(24) of this chapter; and recognized as safe (GRAS) as direct texturizer as defined in § 170.3(o)(32) of human food ingredients is based upon this chapter. the following current good manufac- (2) The ingredient is used in food at turing practice conditions of use: levels not to exceed current good man- (1) The ingredients are used as emul- ufacturing practice. sifiers as defined in § 170.3(o)(8) of this (d) Prior sanctions for this ingredient chapter and as stabilizers and thick- different from the uses established in eners as defined in § 170.3(o)(28) of this this section do not exist or have been chapter. waived. (2) The ingredients are used in food at levels not to exceed current good [48 FR 48806, Oct. 21, 1983] manufacturing practice.

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(d) Prior sanctions for these ingredi- sium alginate is prepared by the neu- ents different from the uses established tralization of purified alginic acid with in this section do not exist or have appropriate pH control agents. been waived. (b) The ingredient meets the speci- [48 FR 51149, Nov. 7, 1983] fications of the Food Chemicals Codex, 3d Ed. (1981), p. 239, which is incor- § 184.1595 Pepsin. porated by reference. Copies are available from the National Academy Press, (a) Pepsin (CAS Reg. No. 9001–75–6) is 2101 Constitution Ave. NW., Wash- an enzyme preparation obtained from ington, DC 20418, or available for in- the glandular layer of hog stomach. It spection at the National Archives and is a white to light tan powder, amber Records Administration (NARA). For paste, or clear amber to brown liquid. information on the availability of this Its characterizing enzyme activity is material at NARA, call 202–741–6030, or that of a peptide hydrolase (EC go to: http://www.archives.gov/ 3.4.23.1). federal register/ (b) The ingredient meets the general l code of federal regulations/ requirements and additional require- l l l ibr locations.html. ments for enzyme preparations in the l Food Chemicals Codex, 3d ed. (1981), p. (c) In accordance with § 184.1(b)(2), 110, which is incorporated by reference the ingredient is used in food only in accordance with 5 U.S.C. 552(a) and 1 within the following specific limita- CFR part 51. Copies are available from tions: the National Academy Press, 2101 Con- Maximum stitution Ave. NW., Washington, DC level of use in 20418, or may be examined at the Office Category of food food (as Functional use of Premarket Approval (HFS–200), Food served) and Drug Administration, 5100 Paint (percent) Branch Pkwy., College Park, MD 20740, Confections and 0.1 Stabilizer, thickener, and at the National Archives and frostings, § 170.3(o)(28) of this Records Administration (NARA). For § 170.3(n)(9) of this chapter chapter. information on the availability of this Gelatins and puddings, 0.7 Do. material at NARA, call 202–741–6030, or § 170.3(n)(22) of this go to: http://www.archives.gov/ chapter. federallregister/ Processed fruits and 0.25 Do. fruit juices, codeloflfederallregulations/ § 170.3(n)(35) of this ibrllocations.html. chapter. (c) In accordance with § 184.1(b)(1), All other food cat- 0.01 Do. the ingredient is used in food with no egories. limitation other than current good manufacturing practice. The affirma- (d) Prior sanctions for potassium al- tion of this ingredient as GRAS as a di- ginate different from the uses estab- rect food ingredient is based upon the lished in this section do not exist or following current good manufacturing have been waived. practice conditions of use: [47 FR 29951, July 9, 1982] (1) The ingredient is used as an enzyme as defined in § 170.3(o)(9) of this § 184.1613 Potassium bicarbonate. chapter to hydrolyze proteins or (a) Potassium bicarbonate (KHCO3, polypeptides. CAS Reg. No. 298–14–6) is made by the (2) The ingredient is used in food at following processes: levels not to exceed current good man- (1) By treating a solution of potas- ufacturing practice. sium hydroxide with carbon dioxide; [60 FR 32911, June 26, 1995] (2) By treating a solution of potassium carbonate with carbon dioxide. § 184.1610 Potassium alginate. (b) The ingredient meets the speci- (a) Potassium alginate (CAS Reg. No. fications of the Food Chemicals Codex, 9005–36–1) is the potassium salt of al- 3d Ed. (1981), p. 239, which is incor- ginic acid, a natural polyuronide con- porated by reference. Copies are avail- stituent of certain brown algae. Potas- able from the National Academy Press,

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2101 Constitution Ave. NW., Wash- Records Administration (NARA). For ington, DC 20418, or available for in- information on the availability of this spection at the National Archives and material at NARA, call 202–741–6030, or Records Administration (NARA). For go to: http://www.archives.gov/ information on the availability of this federallregister/ material at NARA, call 202–741–6030, or codeloflfederallregulations/ go to: http://www.archives.gov/ ibrllocations.html. federallregister/ (c) In accordance with § 184.1(b)(1), codeloflfederallregulations/ the ingredient is used in food with no ibrllocations.html. limitation other than current good (c) In accordance with § 184.1(b)(1), manufacturing practice. the affirma- the ingredient is used in food with no tion of this ingredient as generally rec- limitation other than current good ognized as safe (GRAS) as a direct manufacturing practice. The affirma- human food ingredient is based upon tion of this ingredient as generally rec- the following current good manufac- ognized as safe (GRAS) as a direct turing practice conditions of use: human food ingredient is based upon (1) The ingredient is used in food as a the following current good manufac- flavoring agent and adjuvant as defined turing practice conditions of use: in § 170.3(o)(12) of this chapter; nutrient (1) The ingredient is used as a formu- supplement as defined in § 170.3(o)(20) of lation aid as defined in § 170.3(o)(14) of this chapter; pH control agent as de- this chapter; nutrient supplemlent as fined in § 170.3(o)(23) of this chapter; defined in § 170.3(o)(20) of this chapter; and processing aid as defined in pH control agent as defined in § 170.3(o)(24) of this chapter. § 170.3(o)(23) of this chapter; and proc- (2) The ingredient is used in food at essing aid as defined in § 170.3(o)(24) of levels not to exceed current good man- this chapter. ufacturing practice. (2) The ingredient is used in food at (d) Prior sanctions for this ingredient levels not to exceed current good man- different from the uses established in ufacturing practice. this section do not exist or have been (d) Prior sanctions for this ingredient waived. different from the uses established in [48 FR 52442, Nov. 18, 1983] this section do not exist or have been waived. § 184.1622 Potassium chloride. [48 FR 52442, Nov. 18, 1983] (a) Potassium chloride (KCl, CAS Reg. No. 7447–40–7) is a white, odorless § 184.1619 Potassium carbonate. solid prepared from source minerals by (a) Potassium carbonate (K2CO3, CAS fractional crystallization or flotation. Reg. No. 584–08–7) is produced by the It is soluble in water and glycerol and following methods of manufacture: has a saline taste at low concentration (1) By electrolysis of potassium chlo- levels. ride followed by exposing the resultant (b) The ingredient meets the speci- potassium to carbon dioxide; fications of the Food Chemicals Codex, (2) By treating a solution of potas- 3d Ed. (1981), p. 241, which is incor- sium hydroxide with excess carbon di- porated by reference. Copies are avail- oxide to produce potassium carbonate; able from the National Academy Press, (3) By treating a solution of potas- 2101 Constitution Ave. NW., Wash- sium hydroxide with carbon dioxide to ington, DC 20418, or available for in- produce potassium bicarbonate, which spection at the National Archives and is then heated to yield potassium car- Records Administration (NARA). For bonate. information on the availability of this (b) The ingredient meets the speci- material at NARA, call 202–741–6030, or fications of the Food Chemicals Codex, go to: http://www.archives.gov/ 3d Ed. (1981), p. 240, which is incor- federallregister/ porated by reference. Copies are avail- codeloflfederallregulations/ able from the National Academy Press, ibrllocations.html. 2101 Constitution Ave. NW., Wash- (c) In accordance with § 184.1(b)(1), ington, D.C. 20418, or available for in- the ingredient is used in food with no spection at the National Archives and limitation other than current good

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manufacturing practice. The affirma- codeloflfederallregulations/ tion of this ingredient as generally rec- ibrllocations.html. ognized as safe (GRAS) as a direct (c) In accordance with § 184.1(b)(1), human food ingredient is based upon the ingredient is used in food with no the following current good manufac- limitation other than current good turing practice conditions of use: manufacturing practice. (1) The ingredient is used as a flavor (d) Prior sanctions for this ingredient enhancer as defined in § 170.3(o)(11) of different from the uses established in this chapter; as a flavoring agent as de- this section, or different from those set fined in § 170.3(o)(12) of this chapter; as forth in part 181 of this chapter, do not a nutrient supplement as defined in exist or have been waived. § 170.3(o)(20) of this chapter; as a pH control agent as defined in § 170.3(o)(23) [59 FR 63896, Dec. 12, 1994] of this chapter; and as a stabilizer or thickener as defined in § 170.3(o)(28) of § 184.1631 Potassium hydroxide. this chapter. (a) Potassium hydroxide (KOH, CAS (2) The ingredient is used in food at Reg. No. 1310–58–3) is also known as levels not to exceed current good man- caustic potash, potash lye, and potassa. ufacturing practice. Potassium chlo- The empirical formula is KOH. It is a ride may be used in infant formula in white, highly deliquescent caustic accordance with section 412(g) of the solid, which is marketed in several Federal Food, Drug, and Cosmetic Act forms, including pellets, flakes, sticks, (the Act) or with regulations promul- lumps, and powders. Potassium hydrox- gated under section 412(a)(2) of the Act. ide is obtained commercially from the (d) Prior sanctions for this ingredient electrolysis of potassium chloride solu- different from the uses established in tion in the presence of a porous dia- this section do not exist or have been phragm. waived. (b) The ingredient meets the speci- [48 FR 51614, Nov. 10, 1983] fications of the Food Chemicals Codex, 3d Ed. (1981), which is incorporated by § 184.1625 Potassium citrate. reference. Copies are available from the National Academy Press, 2101 Con- (a) Potassium citrate (C6H5K3O7·H2O, CAS Reg. No. 006100–0905–096) is the po- stitution Ave. NW., Washington, DC tassium salt of citric acid. It is pre- 20418, or available from inspection at pared by neutralizing citric acid with the National Archives and Records Ad- potassium hydroxide or potassium car- ministration (NARA). For information bonate. It occurs as transparent crys- on the availability of this material at tals or a white granular powder, is NARA, call 202–741–6030, or go to: http:// odorless and deliquescent, and contains www.archives.gov/federallregister/ one mole of water per mole of potas- codeloflfederallregulations/ sium citrate. ibrllocations.html. (b) The ingredient meets the speci- (c) In accordance with § 184.1(b)(1), fications of the Food Chemicals Codex, the ingredient is used in food with no 3d ed. (1981), p. 242, which is incor- limitation other than current good porated by reference in accordance manufacturing practice. The affirma- with 5 U.S.C. 552(a) and 1 CFR part 51. tion of this ingredient as generally rec- Copies are available from the National ognized as safe (GRAS) as a direct Academy Press, 2101 Constitution Ave. human food ingredient is based upon NW., Washington, DC 20418, and the the following current good manufac- Center for Food Safety and Applied Nu- turing practice conditions of use: trition (HFS–200), 5100 Paint Branch (1) The ingredient is used as a formu- Pkwy., College Park, MD 20740, or may lation aid as defined in § 170.3(o)(14) of be examined at the National Archives this chapter; a pH control agent as de- and Records Administration (NARA). fined in § 170.3(o)(23) of the chapter; a For information on the availability of processing aid as defined in § 170.3(o)(24) this material at NARA, call 202–741– of this chapter; and a stabilizer and 6030, or go to: http://www.archives.gov/ thickener as defined in § 170.3(o)(28) of federallregister/ this chapter.

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(2) The ingredient is used in food at Academy Press, 2101 Constitution Ave. levels not to exceed current good man- NW., Washington, DC 20418, or may be ufacturing practice. examined at the National Archives and (d) Prior sanctions for this ingredient Records Administration (NARA). For different from the uses established in information on the availability of this this section do not exist or have been material at NARA, call 202–741–6030, or waived. go to: http://www.archives.gov/ federallregister/ [48 FR 52444, Nov. 18, 1983] codeloflfederallregulations/ § 184.1634 Potassium iodide. ibrllocations.html. (c) The ingredient is used as a dough (a) Potassium iodide (KI, CAS Reg. strengthener as defined in § 170.3(o)(6) No. 7681–11–0) is the potassium salt of of this chapter. hydriodic acid. It occurs naturally in (d) The ingredient is used in the man- sea water and in salt deposits, but can ufacture of bread in accordance with be prepared by reacting hydriodic acid § 184.1(b)(2) of this chapter in an (HI) with potassium bicarbonate amount not to exceed 0.0075 percent (KHCO ). 3 based on the weight of the flour. (b) The ingredient meets the speci- (e) Prior sanctions for this ingredient fications of the ‘‘Food Chemicals different from the uses established in Codex,’’ 3d Ed. (1981), pp. 246–247, which this section do not exist or have been is incorporated by reference. Copies waived. may be obtained from the National Academy Press, 2101 Constitution Ave. [43 FR 11699, Mar. 21, 1978, as amended at 49 NW., Washington, DC 20418, or may be FR 5613, Feb. 14, 1984] examined at the National Archives and Records Administration (NARA). For § 184.1639 Potassium lactate.

information on the availability of this (a) Potassium lactate (C3H5O3K, CAS material at NARA, call 202–741–6030, or Reg. No. 996–31–6) is the potassium salt go to: http://www.archives.gov/ of lactic acid. It is a hydroscopic, federallregister/ white, odorless solid and is prepared codeloflfederallregulations/ commercially by the neutralization of ibrllocations.html. lactic acid with potassium hydroxide. (c) The ingredient is used as a nutri- (b) The ingredient must be of a pu- ent supplement as defined in rity suitable for its intended use. § 170.3(o)(20) of this chapter. (c) In accordance with § 184.1(b)(1), (d) The ingredient is used in table the ingredient is used in food with no salt in accordance with § 184.1(b)(2) of limitation other than current good this chapter as a source of dietary io- manufacturing practice. This regula- dine at a maximum level of 0.01 per- tion does not authorize its use in in- cent. fant foods and infant formulas. The af- (e) Prior sanctions for this ingredient firmation of this ingredient as gen- different from the uses established in erally recognized as safe (GRAS) as a this section do not exist or have been direct human food ingredient is based waived. upon the following current good manu- [43 FR 11699, Mar. 21, 1978, as amended at 49 facturing practice conditions of use: FR 5613, Feb. 14, 1984; 61 FR 14247, Apr. 1, (1) The ingredient is used as a flavor 1996] enhancer as defined in § 170.3(o)(11) of this chapter; a flavoring agent or adju- § 184.1635 Potassium iodate. vant as defined in § 170.3(o)(12) of this

(a) Potassium iodate (KIO3, CAS Reg. chapter; a humectant as defined in No. 7758–05–6) does not occur naturally § 170.3(o)(16) of this chapter; and a pH but can be prepared by reacting iodine control agent as defined in § 170.3(o)(23) with potassium hydroxide. of this chapter. (b) The ingredient meets the speci- (2) The ingredient is used in food at fications of the ‘‘Food Chemicals levels not to exceed current good man- Codex,’’ 3d Ed. (1981), pp. 245–246, which ufacturing practice. is incorporated by reference. Copies (d) Prior sanctions for this ingredient may be obtained from the National different from the uses established in

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this section do not exist or have been sorption to surface-active agents, or re- waived. frigeration. (b) The ingredient must be of a pu- [52 FR 10886, Apr. 6, 1987, as amended at 73 FR 8608, Feb. 14, 2008] rity suitable for its intended use. (c) In accordance with § 184.1(b)(1), § 184.1643 Potassium sulfate. the ingredient is used in food with no limitations other than current good (a) Potassium sulfate (K2SO4, CAS manufacturing practice. The affirma- Reg. No. 7778–80–5) occurs naturally and tion of this ingredient as generally rec- consists of colorless or white crystals ognized as safe (GRAS) as a direct or crystalline powder having a bitter, human food ingredient is based upon saline taste. It is prepared by the neu- the following current good manufac- tralization of sulfuric acid with potas- turing practice conditions of use: sium hydroxide or potassium car- (1) The ingredient is used as a propel- bonate. lant, aerating agent, and gas as defined (b) The ingredient meets the speci- in § 170.3(o)(25) of this chapter. fications of the ‘‘Food Chemicals (2) The ingredient is used in food at Codex,’’ 3d Ed. (1981), p. 252, which is in- levels not to exceed current good man- corporated by reference. Copies may be ufacturing practice. obtained from the National Academy (d) Prior sanctions for this ingredient Press, 2101 Constitution Ave. NW., different from the uses established in Washington, DC 20418, or may be exam- this section do not exist or have been ined at the National Archives and waived. Records Administration (NARA). For information on the availability of this [48 FR 57271, Dec. 29, 1983, as amended at 73 FR 8608, Feb. 14, 2008] material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ § 184.1660 Propyl gallate. federallregister/ (a) Propyl gallate is the n- codeloflfederallregulations/ propylester of 3,4,5-trihydroxybenzoic ibrllocations.html. (c) The ingredient is used as a fla- acid (C10H12O5). Natural occurrence of voring agent and adjuvant as defined in propyl gallate has not been reported. It § 170.3(o)(12) of this chapter. is commercially prepared by esterification of gallic acid with propyl (d) The ingredient is used in food at alcohol followed by distillation to re- levels not to exceed good manufac- move excess alcohol. turing practice in accordance with (b) The ingredient meets the speci- § 184.1(b)(1). Current good manufac- fications of the ‘‘Food Chemicals turing practice results in a maximum Codex,’’ 3d Ed. (1981), pp. 257–258, which level, as served, of 0.015 percent for is incorporated by reference. Copies nonalcoholic beverages as defined in may be obtained from the National § 170.3(n)(3) of this chapter. Academy Press, 2101 Constitution Ave. (e) Prior sanctions for this ingredient NW., Washington, DC 20418, or may be different from the uses established in examined at the National Archives and this section do not exist or have been Records Administration (NARA). For waived. information on the availability of this [45 FR 6086, Jan. 25, 1980, as amended at 49 material at NARA, call 202–741–6030, or FR 5613, Feb. 14, 1984] go to: http://www.archives.gov/ federallregister/ § 184.1655 Propane. codeloflfederallregulations/ (a) Propane (empirical formula C3H8, ibrllocations.html. CAS Reg. No. 74–98–6) is also known as (c) The ingredient is used as an anti- dimethylmethane or propyl hydrid. It oxidant as defined in § 170.3(o)(3) of this is a colorless, odorless, flammable gas chapter. at normal temperatures and pressures. (d) The ingredient is used in food at It is easily liquefied under pressure at levels not to exceed good manufac- room temperature and is stored and turing practice in accordance with shipped in the liquid state. Propane is § 184.1(b)(1). Good manufacturing prac- obtained from natural gas by fraction- tice results in a maximum total con- ation following absorption in oil, ad- tent of antioxidants of 0.02 percent of

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the fat or oil content, including the es- (d) The ingredient is used in foods at sential (volatile) oil content, of the levels not to exceed current good man- food. ufacturing practice in accordance with (e) Prior sanctions for this ingredient § 184.1(b)(1). Current good manufac- different from the uses established in turing practice results in maximum this section, or different from that levels, as served, of 5 percent for alco- stated in part 181 of this chapter, do holic beverages, as defined in not exist or have been waived. § 170.3(n)(2) of this chapter; 24 percent [42 FR 14653, Mar. 15, 1977, as amended at 44 for confections and frostings as defined FR 52826, Sept. 11, 1979; 49 FR 5613, Feb. 14, in § 170.3(n)(9) of this chapter; 2.5 per- 1984] cent for frozen dairy products as defined in § 170.3(n)(20) of this chapter; 97 § 184.1666 Propylene glycol. percent for seasonings and flavorings as defined in § 170.3(n)(26) of this chap- (a) Propylene glycol (C3H8O2, CAS Reg. No. 57–55–6) is known as 1,2- ter; 5 percent for nuts and nut products propanediol. It does not occur in na- as defined in § 170.3(n)(32) of this chap- ture. Propylene glycol is manufactured ter; and 2.0 percent for all other food by treating propylene with chlorinated categories. water to form the chlorohydrin which (e) Prior sanctions for this ingredient is converted to the glycol by treatment different from the uses established in with sodium carbonate solution. It is this section do not exist or have been also prepared by heating glyercol with waived. sodium hydroxide. (b) The ingredient meets the speci- [47 FR 27812, June 25, 1982] fications of the Food Chemicals Codex, § 184.1670 Propylparaben. 3d Ed. (1981), p. 255, which is incorporated by reference. Copies may be (a) Propylparaben is the chemical obtained from the National Academy propyl p-hydroxybenzoate. It is pro- Press, 2101 Constitution Ave. NW., duced by the n-propanol esterification Washington, DC 20418. It is also avail- of p-hydroxybenzoic acid in the pres- able for inspection at the National Ar- ence of sulfuric acid, with subsequent chives and Records Administration distillation. (NARA). For information on the avail- (b) The ingredient meets the speci- ability of this material at NARA, call fications of the ‘‘Food Chemicals 202–741–6030, or go to: http:// Codex,’’ 3d Ed. (1981), p. 258, which is in- www.archives.gov/federallregister/ corporated by reference. Copies may be codeloflfederallregulations/ obtained from the National Academy ibrllocations.html. Press, 2101 Constitution Ave. NW., (c) The ingredient is used as an Washington, DC 20418, or may be exam- anticaking agent as defined in ined at the National Archives and § 170.3(o)(1) of this chapter; antioxidant Records Administration (NARA). For as defined in § 170.3(o)(3) of this chap- information on the availability of this ter; dough strengthener as defined in material at NARA, call 202–741–6030, or § 170.3(o)(6) of this chapter; emulsifier go to: http://www.archives.gov/ as defined in § 170.3(o)(8) of this chap- federallregister/ ter; flavor agent as defined in codeloflfederallregulations/ § 170.3(o)(12) of this chapter; formula- ibrllocations.html. tion aid as defined in § 170.3(o)(14) of this chapter; humectant as defined in (c) The ingredient is used as an anti- § 170.3(o)(16) of this chapter; processing microbial agent as defined in aid as defined in § 170.3(o)(24) of this § 170.3(o)(2) of this chapter. chapter; solvent and vehicle as defined (d) The ingredient is used in food at in § 170.3(o)(27) of this chapter; sta- levels not to exceed good manufac- bilizer and thickener as defined in turing practices. Current good manu- § 170.3(o)(28) of this chapter; surface-ac- facturing practice results in a max- tive agent as defined in § 170.3(o)(29) of imum level of 0.1 percent in food. this chapter; and texturizer as defined (e) Prior sanctions for this ingredient in § 170.3(o)(32) of this chapter. different from the uses established in

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this regulation do not exist or have Cosmetic Act (the Act) or with regula- been waived. tions promulgated under section 412(a)(2) of the Act. [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984] (d) Prior sanctions for this ingredient different from the uses established in § 184.1676 Pyridoxine hydrochloride. this section do not exist or have been (a) Pyridoxine hydrochloride waived. (C8H11NO3·HCl, CAS Reg. No. 58–56–0) is [48 FR 51615, Nov. 10, 1983] the chemical 3-hydroxy–4,5- dihydroxymethy–2-methylpyridine hy- § 184.1685 Rennet (animal-derived) drochloride that is prepared by chem- and chymosin preparation (fer- ical synthesis. mentation-derived). (b) The ingredient meets the speci- (a)(1) Rennet and bovine rennet are fications of the Food Chemicals Codex, commercial extracts containing the ac- 3d Ed. (1981), p. 260, which is incor- tive enzyme rennin (CAS Reg. No. 9001– porated by reference. Copies are avail- 98–3), also known as chymosin (Inter- able from the National Academy Press, national Union of Biochemistry En- 2101 Constitution Ave. NW., Wash- zyme Commission (E.C.) 3.4.23.4). ington, DC 20418, or available for in- Rennet is the aqueous extract prepared spection at the National Archives and from cleaned, frozen, salted, or dried Records Administration (NARA). For fourth stomachs (abomasa) of calves, information on the availability of this kids, or lambs. Bovine rennet is the material at NARA, call 202–741–6030, or product from adults of the animals list- go to: http://www.archives.gov/ ed above. Both products are called federallregister/ rennet and are clear amber to dark codeloflfederallregulations/ brown liquid preparations or white to ibrllocations.html. tan powders. (c) In accordance with § 184.1(b)(1), (2) Chymosin preparation is a clear the ingredient is used in food with no solution containing the active enzyme limitation other than current good chymosin (E.C. 3.4.23.4). It is derived, manufacturing practice. The affirma- via fermentation, from a nonpatho- tion of this ingredient as generally rec- genic and nontoxigenic strain of Esch- ognized as safe (GRAS) as a direct erichia coli K–12 containing the human food ingredient is based upon prochymosin gene. The prochymosin is the following current good manufac- isolated as an insoluble aggregate that turing practice conditions of use: is acid-treated to destroy residual cel- (1) The ingredient is used as a nutri- lular material and, after solubilization, ent supplement as defined in is acid-treated to form chymosin. It § 170.3(o)(20) of this chapter. must be processed with materials that (2) The ingredient is used in the fol- are generally recognized as safe, or are lowing foods at levels not to exceed food additives that have been approved current good manufacturing practice: by the Food and Drug Administration baked goods as defined in § 170.3(n)(1) of for this use. this chapter; nonalcoholic beverages (3) Chymosin preparation is a clear and beverage bases as defined in solution containing the active enzyme § 170.3(n)(3) of this chapter; breakfast chymosin (E.C. 3.4.23.4). It is derived, cereals as defined in § 170.3(n)(4) of this via fermentation, from a nonpatho- chapter; dairy product analogs as de- genic and nontoxigenic strain of fined in § 170.3(n)(10) of this chapter; Kluyveromyces marxianus variety lactis, meat products as defined in containing the prochymosin gene. The § 170.3(n)(29) of this chapter; milk prod- prochymosin is secreted by cells into ucts as defined in § 170.3(n)(31) of this fermentation broth and converted to chapter; plant protein products as de- chymosin by acid treatment. All mate- fined in § 170.3(n)(33) of this chapter; rials used in the processing and formu- and snack foods as defined in lating of chymosin must be either gen- § 170.3(n)(37) of this chapter. Pyridoxine erally recognized as safe (GRAS), or be hydrochloride may be used in infant food additives that have been approved formula in accordance with section by the Food and Drug Administration 412(g) of the Federal Food, Drug, and for this use.

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(4) Chymosin preparation is a clear ter; and milk products as defined in solution containing the active enzyme § 170.3(n)(31) of this chapter. chymosin (E.C. 3.4.23.4). It is derived, (d) Prior sanctions for this ingredient via fermentation, from a nonpatho- different from the uses established in genic and nontoxigenic strain of Asper- this section do not exist or have been gillus niger van Tieghem variety waived. awamori (Nakazawa) Al-Musallam (syn- onym A. awamori Nakazawa) con- [55 FR 10935, Mar. 23, 1990, as amended at 57 taining the prochymosin gene. FR 6479, Feb. 25, 1992; 58 FR 27202, May 7, 1993] Chymosin is recovered from the fermentation broth after acid treatment. § 184.1695 Riboflavin. All materials used in the processing and formulating of chymosin prepara- (a) Riboflavin (C17H20N4O6, CAS Reg. tion must be either generally recog- No. 83–88–5) occurs as yellow to orange- nized as safe (GRAS) or be food addi- yellow needles that are crystallized tives that have been approved by the from 2N acetic acid, alcohol, water, or Food and Drug Administration for this pyridine. It may be prepared by chem- use. ical synthesis, biosynthetically by the (b) Rennet and chymosin preparation organism Eremothecium ashbyii, or iso- meet the general and additional related from natural sources. quirements for enzyme preparations of (b) The ingredient meets the speci- the ‘‘Food Chemicals Codex,’’ 3d Ed. fications of the Food Chemicals Codex, (1981), pp. 107–110, which is incorporated 3d Ed. (1981), p. 262, which is incor- by reference in accordance with 5 porated by reference. Copies are avail- U.S.C. 552(a). Copies are available from able from the National Academy Press, the National Academy Press, 2101 Con- 2101 Constitution Ave. NW., Wash- stitution Avenue NW., Washington, DC ington, DC 20418, or available for in- 20418, or are available for inspection at spection at the National Archives and the National Archives and Records Ad- Records Administration (NARA). For ministration (NARA). For information information on the availability of this on the availability of this material at material at NARA, call 202–741–6030, or NARA, call 202–741–6030, or go to: http:// go to: http://www.archives.gov/ www.archives.gov/federallregister/ federallregister/ code of federal regulations/ l l l codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (c) In accordance with § 184.1(b)(1), (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no the ingredient is used in food with no limitation other than current good limitation other than current good manufacturing practice. The affirma- manufacturing practice. The affirmation of this ingredient as generally recognized as safe as a direct human food tion of this ingredient as generally rec- ingredient is based upon the following ognized as safe (GRAS) as a direct current good manufacturing practice human food ingredient is based upon conditions of use: the following current good manufac- (1) The ingredient is used as an en- turing practice conditions of use: zyme as defined in § 170.3(o)(9) of this (1) The ingredient is used as a nutri- chapter; a processing aid as defined in ent supplement as defined in § 170.3(o)(24) of this chapter; and a sta- § 170.3(o)(20) of this chapter. bilizer and thickener as defined in (2) The ingredient is used in foods at § 170.3(o)(28) of this chapter. levels not to exceed current good man- (2) The ingredient is used in the fol- ufacturing practice. The ingredient lowing foods at levels not to exceed may also be used in infant formula in current good manufacturing practice: accordance with section 412(g) of the In cheeses as defined in § 170.3(n)(5) of Federal Food, Drug, and Cosmetic Act this chapter; frozen dairy desserts and (the Act) or with regulations promul- mixes as defined in § 170.3(n)(20) of this gated under section 412(a)(2) of the Act. chapter; gelatins, puddings, and fillings (d) Prior sanctions for this ingredient as defined in § 170.3(n)(22) of this chap- different from the uses established in

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this section do not exist or have been § 184.1698 Rue. waived. (a) Rue is the perennial herb of sev- [48 FR 51148, Nov. 7, 1983] eral species of Ruta (Ruta montana L., Ruta graveolens L., Ruta bracteosa L., § 184.1697 Riboflavin–5′-phosphate (sodium). and Ruta calepensis L.). The leaves, buds, and stems from the top of the ′ (a) Riboflavin-5 -phosphate (sodium) plant are gathered, dried, and then (C H N O PNa·2H O, CAS Reg. No 130– 17 20 4 9 2 crushed in preparation for use, or left 40–5) occurs as the dihydrate in yellow whole. to orange-yellow crystals. It is prepared by phosphorylation of riboflavin (b) The ingredient is used in all cat- with chlorophosphoric acid, egories of food in accordance with pyrophosphoric acid, metaphosphoric § 184.1(b)(2) of this chapter at con- acid, or pyrocatechol cyclic phosphate. centrations not to exceed 2 parts per (b) The ingredient meets the speci- million. fications of the Food Chemicals Codex, (c) Prior sanctions for this ingredient 3d Ed. (1981), p. 263, which is incor- different from the uses established in porated by reference. Copies are avail- this section do not exist or have been able from the National Academy Press, waived. 2101 Constitution Ave. NW., Wash- ington DC 20418, or available for inspec- [43 FR 3705, Jan. 27, 1978] tion at the National Archives and Records Administration (NARA). For § 184.1699 Oil of rue. information on the availability of this (a) Oil of rue is the natural substance material at NARA, call 202–741–6030, or obtained by steam distillation of the go to: http://www.archives.gov/ fresh blossoming plants of rue, the pe- federallregister/ rennial herb of several species of codeloflfederallregulations/ Ruta—Ruta montana L., Ruta graveolens ibrllocations.html. L., Ruta bracteosa L., and Ruta (c) In accordance with § 184.1(b)(1), calepensis L. the ingredient is used in food with no (b) Oil of rue meets the specifications limitation other than current good of the ‘‘Food Chemicals Codex,’’ 4th ed. manufacturing practice. The affirmation of this ingredient as generally rec- (1996), pp. 342–343, which is incorporated ognized as safe (GRAS) as a direct by reference in accordance with 5 human food ingredient is based upon U.S.C. 552(a) and 1 CFR part 51. Copies the following current good manufac- are available from the National Acad- turing practice conditions of use: emy Press, Box 285, 2101 Constitution (1) The ingredient is used as a nutri- Ave. NW., Washington, DC 20055 (Inter- ent supplement as defined in net address http://www.nap.edu), or may § 170.3(o)(20) of this chapter. be examined at the Center for Food (2) The ingredient is used in milk Safety and Applied Nutrition’s Li- products, as defined in § 170.3(n)(31) of brary, Food and Drug Administration, this chapter, at levels not to exceed 5100 Paint Branch Pkwy., College Park, current good manufacturing practice. MD 20740, or at the National Archives The ingredient may also be used in in- and Records Administration (NARA). fant formulas in accordance with sec- For information on the availability of tion 412(g) of the Federal Food, Drug, this material at NARA, call 202–741– and Cosmetic Act (the Act) or with reg- 6030, or go to: http://www.archives.gov/ ulations promulgated under section federallregister/ 412(a)(2) of the Act. (d) Prior sanctions for this ingredient codeloflfederallregulations/ different from the uses established in ibrllocations.html. this section do not exist or have been (c) The ingredient is used in food waived. under the following conditions: [48 FR 51148, Nov. 7, 1983]

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MAXIMUM USAGE LEVELS PERMITTED

Parts per Food (as served) million Function

Baked goods and baking mixes, § 170.3(n)(1), of 10 Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter. this chapter. Frozen dairy desserts and mixes, § 170.3 (n)(20) of 10 Do. this chapter. Soft candy, § 170.3(n)(38) of this chapter ...... 10 Do. All other food categories ...... 4 Do.

(d) Prior sanctions for this ingredient § 184.1721 Sodium acetate. different from the uses established in (a) Sodium acetate (C H O Na, CAS this section do not exist or have been 2 3 2 Reg. No. 127–09–3 or C H O Na·3H O, waived. 2 3 2 2 CAS Reg. No. 6131–90–4) is the sodium [42 FR 14653, Mar. 15, 1977, as amended at 49 salt of acetic acid and occurs naturally FR 5613, Feb. 14, 1984; 64 FR 1760, Jan. 12, in plant and animal tissues. Sodium ac- 1999] etate may occur in either the anhydrous or trihydrated form. It is pro- § 184.1702 Sheanut oil. duced synthetically by the neutraliza- (a) Sheanut oil is produced from tion of acetic acid with sodium car- sheanuts derived from the Shea tree bonate or by treating calcium acetate Butyrospermum parkii and is composed with sodium sulfate and sodium bicar- principally of triglycerides containing bonate. an oleic acid moiety at the 2-position (b) The ingredient meets the speci- and saturated fatty acids, usually ste- fications of the Food Chemicals Codex, aric or palmitic acids, at the 1- and 3- 3d Ed. (1981), pp. 272, 273 which is incor- positions. porated by reference. Copies are avail- (b) The ingredient meets the fol- able from the National Academy Press, lowing specifications when tested using 2101 Constitution Ave. NW., Wash- any appropriate validated method- ington, DC 20418, or available for in- ology: spection at the National Archives and (1) Saponification value of 185 to 195, Records Administration (NARA). For (2) Iodine value of 28 to 43, information on the availability of this (3) Unsaponifiable matter not to ex- material at NARA, call 202–741–6030, or ceed 1.5 percent, go to: http://www.archives.gov/ (4) Free fatty acids not more than 0.1 federallregister/ percent as oleic acid, codeloflfederallregulations/ (5) Peroxide value not more than 10 ibrllocations.html. milliequivalents/equivalent (meq/eq), (c) The ingredient is used as a fla- (6) Lead not more than 0.1 part per voring agent and adjuvant as defined in million (ppm), § 170.3(o)(12) of this chapter; and as a pH control agent as defined in § 170.3(o)(23) (7) Copper not more than 0.1 ppm. of this chapter. (c) In accordance with § 184.1(b)(3), (d) The ingredient is used in food at the ingredient is used in the following levels not to exceed current good man- food categories at levels not to exceed ufacturing practice in accordance with current good manufacturing practice, 184.1(b)(1). Current good manufacturing except that the ingredient may not be practice results in a maximum level, as used in a standardized food unless per- served, of 0.007 percent for breakfast mitted by the standard of identity: cereals as defined in § 170.3(n)(4) of this Confections and frostings as defined in chapter; 0.5 percent for fats and oils as § 170.3(n)(9) of this chapter, coatings of defined in § 170.3(n)(12) of this chapter; soft candy as defined in § 170.3(n)(38) of 0.6 percent for grain products and pas- this chapter, and sweet sauces and top- tas as defined in § 170.3(n)(23) of this pings as defined in § 170.3(n)(43) of this chapter and snack foods as defined in chapter. § 170.3(n)(37) of this chapter; 0.15 per- [63 FR 28895, May 27, 1998] cent for hard candy as defined in

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§ 170.3(n)(25) of this chapter; 0.12 per- nate is prepared by the neutralization cent for jams and jellies as defined in of purified alginic acid with appro- § 170.3(n)(28) of this chapter and meat priate pH control agents. products as defined in § 170.3(n)(29) of (b) The ingredient meets the speci- this chapter; 0.2 percent for soft candy fications of the Food Chemicals Codex, as defined in § 170.3(n)(38) of this chap- 3d Ed. (1981), p. 274, which is incor- ter; 0.05 percent for soups and soup porated by reference. Copies are avail- mixes as defined in § 170.3(n)(40) of this able from the National Academy Press, chapter and sweet sauces as defined in 2101 Constitution Ave. NW., Wash- § 170.3(n)(43) of this chapter. ington, DC 20418, or available for in- (e) Prior sanctions for this ingredient spection at the National Archives and different from the uses established in Records Administration (NARA). For this section do not exist or have been information on the availability of this waived. material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ [47 FR 27815, June 25, 1982] federallregister/ codeloflfederallregulations/ § 184.1724 Sodium alginate. ibrllocations.html. (a) Sodium alginate (CAS Reg. No. (c) In accordance with § 184.1(b)(2), 9005–38–3) is the sodium salt of alginic the ingredient is used in food only acid, a natural polyuronide constituent within the following specific limita- of certain brown algae. Sodium algi- tions:

Maximum level of Category of food use in food Functional use (as served) (percent)

Condiments and relishes, § 170.3(n)(8) of this chapter, 1.0 Texturizer, § 170.3(o)(32) of this chapter, formulation aid except pimento ribbon for stuffed olives. § 170.3(o)(14) of this chapter, stabilizer, thickener, § 170.3(o)(28) of this chapter. Pimento ribbon for stuffed olives ...... 6.0 Do. Confections and frostings, § 170.3(n)(9) of this chapter .. 0.3 Stabilizer, thickener, § 170.3(o)(28) of this chapter. Gelatins and puddings, § 170.3(n)(22) of this chapter ..... 4.0 Firming agent, § 170.3(o)(10) of this chapter; flavor adjuvant, § 170.3(o)(12) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter. Hard candy, § 170.3(n)(25) of this chapter ...... 10.0 Stabilizer, thickener, § 170.3(o)(28) of this chapter. Processed fruits and fruit juices, § 170.3(n)(35) of this 2.0 Formulation aid, §170.3(o)(14) of this chapter; chapter. texturizer, § 170.3(o)(32) of this chapter. All other food categories ...... 1.0 Emulsifier, § 170.3(o)(8) of this chapter; firming agent, § 170.3(o)(10) of this chapter; flavor enhancer, § 170.3(o)(11) of this chapter; flavor adjuvant, § 170.3(o)(12) of this chapter; processing aid, § 170.3(o)(24) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter; surface active agent, § 170.3(o)(29) of this chapter.

(d) Prior sanctions for sodium algi- (b) The ingredient meets the speci- nate different from the uses established fications of the ‘‘Food Chemicals in this section do not exist or have Codex,’’ 3d Ed. (1981), p. 278, which is in- been waived. corporated by reference. Copies may be obtained from the National Academy [47 FR 29951, July 9, 1982, as amended at 48 FR 52448, Nov. 18, 1983] Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be exam- § 184.1733 Sodium benzoate. ined at the National Archives and Records Administration (NARA). For (a) Sodium benzoate is the chemical information on the availability of this benzoate of soda (C H NaO ), produced 7 5 2 material at NARA, call 202–741–6030, or by the neutralization of benzoic acid go to: http://www.archives.gov/ with sodium bicarbonate, sodium car- federallregister/ bonate, or sodium hydroxide. The salt codeloflfederallregulations/ is not found to occur naturally. ibrllocations.html.

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(c) The ingredient is used as an anti- § 184.1742 Sodium carbonate. microbial agent as defined in (a) Sodium carbonate (Na2CO3, CAS § 170.3(o)(2) of this chapter, and as a fla- Reg. No. 497–19–8) is produced (1) from voring agent and adjuvant as defined in purified trona ore that has been § 170.3(o)(12) of this chapter. calcined to soda ash; (2) from trona ore (d) The ingredient is used in food at calcined to impure soda ash and then levels not to exceed good manufac- purified; or (3) synthesized from lime- turing practice. Current usage results stone by the Solvay process. in a maximum level of 0.1 percent in (b) The ingredient meets the speci- food. (The Food and Drug Administra- fications of the Food Chemicals Codex, tion has not determined whether 3d Ed. (1981), p. 280, which is incor- significally different conditions of use porated by reference. Copies are avail- would be GRAS.) able from the National Academy Press, (e) Prior sanctions for this ingredient 2101 Constitution Ave. NW., Wash- different from the uses established in ington, DC 20418, or available for in- this section, or different from that set spection at the National Archives and forth in part 181 of this chapter, do not Records Administration (NARA). For exist or have been waived. information on the availability of this material at NARA, call 202–741–6030, or [42 FR 14653, Mar. 15, 1977, as amended at 49 go to: http://www.archives.gov/ FR 5613, Feb. 14, 1984] federallregister/ codeloflfederallregulations/ § 184.1736 Sodium bicarbonate. ibrllocations.html.

(a) Sodium bicarbonate (NaHCO3, (c) In accordance with § 184.1(b)(1), CAS Reg. No. 144–55–8) is prepared by the ingredient is used in food with no treating a sodium carbonate or a so- limitation other than current good dium carbonate and sodium bicarbon- manufacturing practice. The affirma- ate solution with carbon dioxide. As tion of this ingredient as generally rec- carbon dioxide is absorbed, a suspen- ognized as safe (GRAS) as a direct sion of sodium bicarbonate forms. The human food ingredient is based upon slurry is filtered, forming a cake which the following current good manufacturing practice conditions of use: is washed and dried. (1) The ingredient is used in food as (b) The ingredient meets the speci- an antioxidant as defined in § 170.3(o)(3) fications of the Food Chemicals Codex, of this chapter; curing and pickling 3d Ed. (1981), p. 278, which is incor- agent as defined in § 170.3(o)(5) of this porated by reference. Copies are avail- chapter; flavoring agent and adjuvant able from the National Academy Press, as defined in § 170.3(o)(12) of this chap- 2101 Constitution Ave. NW., Wash- ter; pH control agent as defined in ington, DC 20418, or available for in- § 170.3(o)(23) of this chapter; and proc- spection at the National Archives and essing aid as defined in § 170.3(o)(24) of Records Administration (NARA). For this chapter. information on the availability of this (2) The ingredient is used in food at material at NARA, call 202–741–6030, or levels not to exceed current good man- go to: http://www.archives.gov/ ufacturing practice. federallregister/ (d) Prior sanctions for this ingredient codeloflfederallregulations/ different from the uses established in ibrllocations.html. this section do not exist or have been (c) In accordance with § 184.1(b)(1), waived. the ingredient is used in food with no [48 FR 52442, Nov. 18, 1983, as amended at 50 limitation other than current good FR 49536, Dec. 3, 1985] manufacturing practice. (d) Prior sanctions for this ingredient § 184.1751 Sodium citrate. different from the uses established in (a) Sodium citrate (C6H5Na3O7·2H2O, this section do not exist or have been CAS Reg. No. 68–0904–092) is the sodium waived. salt of citric acid. It is prepared by neutralizing citric acid with sodium [48 FR 52442, Nov. 18, 1983] hydroxide or sodium carbonate. The

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product occurs as colorless crystals or codeloflfederallregulations/ a white crystalline powder. It may be ibrllocations.html. prepared in an anhydrous state or may (c) The ingredient is used as an anti- contain two moles of water per mole of microbial agent as defined in sodium citrate. § 170.3(o)(2) of this chapter; flavoring (b) The ingredient meets the speci- agent and adjuvant as defined in fications of the Food Chemicals Codex, § 170.3(o)(12) of this chapter; and pH 3d ed. (1981), pp. 283–284, which is incor- control agent as defined in § 170.3(o)(23) porated by reference in accordance of this chapter. with 5 U.S.C. 552(a) and 1 CFR part 51. (d) The ingredient is used in food at Copies are available from the National levels not to exceed current good man- Academy Press, 2101 Constitution Ave. ufacturing practice in accordance with NW., Washington, DC 20418, and the § 184.1(b)(1). Current good manufac- Center for Food Safety and Applied Nu- turing practice results in a maximum trition (HFS–200), 5100 Paint Branch level, as served, 0.4 percent for baked Pkwy., College Park, MD 20740, or may goods as defined in § 170.3(n)(1) of this be examined at the National Archives chapter; 0.1 percent for fats and oils as and Records Administration (NARA). defined in § 170.3(n)(12) of this chapter, For information on the availability of meat products as defined in this material at NARA, call 202–741– § 170.3(n)(29) of this chapter and soft 6030, or go to: http://www.archives.gov/ candy as defined in § 170.3(n)(38) of this federallregister/ chapter; 0.25 percent for gravies and codeloflfederallregulations/ sauces as defined in § 170.3(n)(24) of this ibrllocations.html. chapter; and 0.05 percent for snack (c) In accordance with § 184.1(b)(1), foods as defined in § 170.3(n)(37) of this the ingredient is used in food with no chapter and soups and soup mixes as defined in § 170.3(n)(40) of this chapter. limitation other than current good (e) Prior sanctions for this ingredient manufacturing practice. different from the uses established in (d) Prior sanctions for this ingredient this section do not exist or have been different from the uses established in waived. this section, or different from those set forth in part 181 of this chapter, do not [47 FR 27815, June 25, 1982] exist or have been waived. § 184.1763 Sodium hydroxide. [59 FR 63896, Dec. 12, 1994] (a) Sodium hydroxide (NaOH, CAS Reg. No. 1310–73–2) is also known as so- § 184.1754 Sodium diacetate. dium hydrate, soda lye, caustic soda, (a) Sodium diacetate (C4H7O4Na·xH2O, white caustic, and lye. The empirical CAS Reg. No. 126–96–5) is a molecular formula is NaOH. Sodium hydroxide is compound of acetic acid, sodium ace- prepared commercially by the elec- tate, and water of hydration. The tech- trolysis of sodium chloride solution nical grade is prepared synthetically and also by reacting calcium hydroxide by reacting sodium carbonate with ace- with sodium carbonate. tic acid. Special grades are produced by (b) The ingredient meets the speci- reacting anhydrous sodium acetate and fications of the Food Chemicals Codex, acetic acid. 3d Ed. (1981), which is incorporated by (b) The ingredient meets the speci- reference. Copies are available from fications of the Food Chemicals Codex, the National Academy Press, 2101 Con- 3d Ed. (1981), p. 284, which is incor- stitution Ave. NW., Washington, DC porated by reference. Copies are avail- 20418, or available for inspection at the able from the National Academy Press, National Archives and Records Admin- 2101 Constitution Ave. NW., Wash- istration (NARA). For information on ington, DC 20418, or available for in- the availability of this material at spection at the National Archives and NARA, call 202–741–6030, or go to: http:// Records Administration (NARA). For www.archives.gov/federallregister/ information on the availability of this codeloflfederallregulations/ material at NARA, call 202–741–6030, or ibrllocations.html. go to: http://www.archives.gov/ (c) In accordance with § 184.1(b)(1), federallregister/ the ingredient is used in food with no

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limitation other than current good § 184.1768 Sodium lactate. manufacturing practice. The affirma- (a) Sodium lactate (C3H5O3Na, CAS tion of this ingredient as generally rec- Reg. No. 72–17–3) is the sodium salt of ognized as safe (GRAS) as a direct lactic acid. It is prepared commercially human food ingredient is based upon by the neutralization of lactic acid the following current good manufac- with sodium hydroxide. turing practice conditions of use: (b) The ingredient must be of a pu- (1) The ingredient is used as a pH rity suitable for its intended use. control agent as defined in § 170.3(o)(23) (c) In accordance with § 184.1(b)(1), of this chapter and as a processing aid the ingredient is used in food with no as defined in § 170.3(o)(24) of this chap- limitation other than current good ter. manufacturing practice. This regula- (2) The ingredient is used in foods at tion does not authorize its use in in- levels not to exceed current good man- fant foods and infant formulas. The af- ufacturing practice. firmation of this ingredient as gen- (d) Prior sanctions for this ingredient erally recognized as safe (GRAS) as a different from the uses established in direct human food ingredient is based this section do not exist or have been upon the following current good manu- waived. facturing practice conditions of use: (1) The ingredient is used as an emul- [48 FR 52444, Nov. 18, 1983] sifier as defined in § 170.3(o)(8) of this chapter; a flavor enhancer as defined in § 184.1764 Sodium hypophosphite. § 170.3(o)(11) of this chapter; a flavoring (a) Sodium hypophosphite (NaH2PO2, agent or adjuvant as defined in CAS Reg. No. 7681–53–0) is a white, § 170.3(o)(12) of this chapter; a humec- odorless, deliquescent granular powder tant as defined in § 170.3(o)(16) of this with a saline taste. It is also prepared chapter; and a pH control agent as de- as colorless, pearly crystalline plates. fined in § 170.3(o)(23) of this chapter. It is soluble in water, alcohol, and (2) The ingredient is used in food at glycerol. It is prepared by neutraliza- levels not to exceed current good man- tion of hypophosphorous acid or by di- ufacturing practice. rect aqueous alkaline hydrolysis of (d) Prior sanctions for this ingredient white phosphorus. different from the uses established in (b) The ingredient must be of a pu- this section do not exist or have been rity suitable for its intended use. waived. (c) In accordance with § 184.1(b)(1), [52 FR 10886, Apr. 6, 1987, as amended at 73 the ingredient is used in food with no FR 8608, Feb. 14, 2008] limitations other than current good manufacturing practice. The affirma- § 184.1769a Sodium metasilicate. tion of this ingredient as generally rec- (a) Sodium metasilicate (CAS Reg. ognized as safe (GRAS) as a direct No. 6834–92–0) is a strongly alkaline human food ingredient is based upon white powder. It does not occur natu- the following current good manufac- rally but rather is synthesized by melt- turing practice conditions of use: ing sand with sodium carbonate at 1400 (1) The ingredient is used as an emul- °C. The commercially available forms sifier or stabilizer, as defined in of sodium metasilicate are the anhy- §§ 170.3(o)(8) and 170.3(o)(28) of this drous form (Na2SiO3), the pentahydrate chapter. (Na2SiO3·5H2O), and the nonahydrate (2) The ingredient is used in cod-liver (Na2SiO3·9H2O). oil emulsions at levels not to exceed (b) The ingredient must be of a pu- current good manufacturing practice. rity suitable for its intended use. (c) In accordance with § 184.1(b)(1), (d) Prior sanctions for this ingredient the ingredient is used in food with no different from the use established in limitation other than current good this section do not exist or have been manufacturing practice. The affirma- waived. tion of this ingredient as generally rec- [47 FR 38277, Aug. 31, 1982, as amended at 73 ognized as safe (GRAS) as a direct FR 8608, Feb. 14, 2008] human food ingredient is based upon

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the following current good manufac- (1) The ingredient is used as an anti- turing practice conditions of use: microbial agent as defined in (1) The ingredient is used as a proc- § 170.3(o)(2) of this chapter and a fla- essing aid as defined in § 170.3(o)(24) of voring agent as defined in § 170.3(o)(12) this chapter. of this chapter. (2) The ingredient is used to treat the (2) The ingredient is used in the fol- following foods at levels not to exceed lowing foods at levels not to exceed current good manufacturing practice: current good manufacturing practice: for use in washing and lye peeling of baked goods as defined in § 170.3(n)(1) of fruits, vegetables, and nuts when used this chapter; nonalcoholic beverages as in accordance with § 173.315 of this defined in § 170.3(n)(3) of this chapter; chapter; for use as a denuding agent in cheeses as defined in § 170.3(n)(5) of this tripe; for use as a hog scald agent in re- chapter; confections and frostings as moving hair; and for use as a corrosion defined in § 170.3(n)(9) of this chapter; preventative in canned and bottled gelatins, puddings, and fillings as de- water when used in accordance with fined in § 170.3(n)(22) of this chapter; § 165.110 of this chapter. jams and jellies as defined in (d) Prior sanctions for this ingredient § 170.3(n)(28) of this chapter; meat prod- different from the uses established in ucts as defined in § 170.3(n)(29) of this this section do not exist or have been chapter; and soft candy as defined in waived. § 170.3(n)(38) of this chapter. [50 FR 38781, Sept. 25, 1985; 50 FR 42011, Oct. (d) Prior sanctions for this ingredient 17, 1985, as amended at 72 FR 10357, Mar. 8, different from the uses established in 2007; 73 FR 8608, Feb. 14, 2008] this section do not exist or have been waived. § 184.1784 Sodium propionate. [49 FR 13142, Apr. 3, 1984] (a) Sodium propionate (C3H5NaO2, CAS Reg. No. 137–40–6) is the sodium § 184.1792 Sodium sesquicarbonate. salt of propionic acid. It occurs as colorless, transparent crystals or a (a) Sodium sesquicarbonate granular crystalline powder. It is odor- (Na2CO3·NaHCO3·2H2O, CAS Reg. No. less, or has a faint acetic-butyric acid 533–96–0) is prepared by: (1) Partial odor, and is deliquescent. It is prepared carbonation of soda ash solution fol- by neutralizing propionic acid with so- lowed by crystallization, centrifuga- dium hydroxide. tion, and drying; (2) double refining of (b) The ingredients meets the speci- trona ore, a naturally occurring im- fications of the Food Chemicals Codex, pure sodium sesquicarbonate. 3d Ed. (1981), p. 296, which is incor- (b) The ingredient meets the speci- porated by reference. Copies are avail- fications of the Food Chemicals Codex, able from the National Academy Press, 3d Ed. (1981), p. 299, which is incor- 2101 Constitution Ave. NW., Wash- porated by reference. Copies are avail- ington DC 20418, or available for inspec- able from the National Academy Press, tion at the National Archives and 2101 Constitution Ave. NW., Wash- Records Administration (NARA). For ington, DC 20418, or available for in- information on the availability of this spection at the National Archives and material at NARA, call 202–741–6030, or Records Administration (NARA). For go to: http://www.archives.gov/ information on the availability of this federallregister/ material at NARA, call 202–741–6030, or codeloflfederallregulations/ go to: http://www.archives.gov/ ibrllocations.html. federallregister/ (c) In accordance with § 184.1(b)(1), codeloflfederallregulations/ the ingredient is used in food with no ibrllocations.html. limitation other than current good (c) In accordance with § 184.1(b)(1), manufacturing practice. The affirma- the ingredient is used in food with no tion of this ingredient as generally rec- limitation other than current good ognized as safe (GRAS) as a direct manufacturing practice. The affirma- human food ingredient is based upon tion of this ingredient as generally rec- the following current good manufac- ognized as safe (GRAS) as a direct turing practice conditions of use: human food ingredient is based upon

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the following current good manufac- and jellies as defined in § 170.3(n)(28) of turing practice conditions of use: this chapter. (1) The ingredient is used as a pH (d) Prior sanctions for this ingredient control agent as defined in § 170.3(o)(23) different from the uses established in of this chapter. this section do not exist or have been (2) The ingredient is used in cream at waived. levels not to exceed current good manufacturing practice. Current good man- [48 FR 52447, Nov. 18, 1983] ufacturing practice utilizes a level of the ingredient sufficient to control lac- § 184.1804 Sodium potassium tartrate. tic acid prior to pasteurization and (a) Sodium potassium tartrate churning of cream into butter. (C4H4KNaO6·4H2O, CAS Reg. No. 304–59– (d) Prior sanctions for this ingredient 6) is the sodium potassium salt of different from the uses established in L¥(+)¥tartaric acid and is also called this section do not exist or have been the Rochelle salt. It occurs as colorless waived. crystals or as a white, crystalline pow- [48 FR 52443, Nov. 18, 1983] der and has a cooling saline taste. It is obtained as a byproduct of wine manu- § 184.1801 Sodium tartrate. facture.

(a) Sodium tartrate (C4H4Na2O6·2H2O, (b) The ingredient meets the speci- CAS Reg. No. 868–18–8) is the disodium fications of the Food Chemicals Codex, salt of L¥(+)¥tartaric acid. It occurs 3d Ed. (1981), p. 296, which is incor- as transparent, colorless, and odorless porated by reference. Copies are avail- crystals. It is obtained as a byproduct able from the National Academy Press, of wine manufacture. 2101 Constitution Ave. NW., Wash- (b) The ingredient meets the speci- ington, DC 20418, or available for in- fications of the Food Chemicals Codex, spection at the National Archives and 3d Ed. (1981), p. 303, which is incor- Records Administration (NARA). For porated by reference. Copies are avail- information on the availability of this able from the National Academy Press, material at NARA, call 202–741–6030, or 2101 Constitution Ave. NW., Wash- go to: http://www.archives.gov/ ington, DC 20418, or available for in- federallregister/ spection at the National Archives and codeloflfederallregulations/ Records Administration (NARA). For ibrllocations.html. information on the availability of this (c) In accordance with § 184.1(b)(1), material at NARA, call 202–741–6030, or the ingredient is used in food with no go to: http://www.archives.gov/ limitation other than current good federallregister/ manufacturing practice. The affirma- codeloflfederallregulations/ tion of this ingredient as generally rec- ibrllocations.html. ognized as safe (GRAS) as a direct (c) In accordance with § 184.1(b)(1), human food ingredient is based upon the ingredient is used in food with no the following current good manufac- limitation other than current good turing practice conditions of use: manufacturing practice. The affirma- (1) The ingredient is used as an emul- tion of this ingredient as generally rec- sifier as defined in § 170.3(o)(8) of this ognized as safe (GRAS) as a direct chapter and as a pH control agent as human food ingredient is based upon defined in § 170.3(o)(23) of this chapter. the following current good manufac- (2) The ingredient is used in the fol- turing practice conditions of use: lowing foods at levels not to exceed (1) The ingredient is used as an emul- current good manufacturing practice: sifier as defined in § 170.3(o)(8) of this cheeses as defined in § 170.3(n)(5) of this chapter and as a pH control agent as chapter and jams and jellies as defined defined in § 170.3(o)(23) of this chapter. in § 170.3(n)(28) of this chapter. (2) The ingredient is used in the fol- (d) Prior sanctions for this ingredient lowing foods at levels not to exceed different from the uses established in current good manufacturing practice: this section do not exist or have been cheeses as defined in§ 170.3(n)(5) of this waived. chapter; fats and oils as defined in § 170.3(n)(12) of this chapter; and jams [48 FR 52447, Nov. 18, 1983]

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§ 184.1807 Sodium thiosulfate. corporated by reference. Copies may be obtained from the National Academy (a) Sodium thiosulfate (Na S O ·5H O, 2 2 3 2 Press, 2101 Constitution Ave. NW., CAS Reg. No. 010102–0917–097) is also Washington, DC 20418, or may be exam- known as sodium hyposulfite. It is pre- ined at the National Archives and pared synthetically by the reaction of Records Administration (NARA). For sulfides and sulfur dioxide (SO ), the 2 information on the availability of this reaction of sulfur and sulfite, or the ox- material at NARA, call 202–741–6030, or idation of metal sulfides and go to: http://www.archives.gov/ hydrosulfides. federallregister/ (b) The ingredient meets the speci- codeloflfederallregulations/ fications of the ‘‘Food Chemicals ibrllocations.html. Codex,’’ 3d Ed. (1981), p. 304, which is in- (c) The ingredient is used as an corporated by reference. Copies may be anticaking agent and free-flow agent as obtained from the National Academy defined in § 170.3(o)(1) of this chapter, Press, 2101 Constitution Ave. NW., curing and pickling agent as defined in Washington, DC 20418, or may be exam- § 170.3(o)(5) of this chapter, drying ined at the National Archives and agent as defined in § 170.3(o)(7) of this Records Administration (NARA). For chapter, emulsifier and emulsifier salt information on the availability of this as defined in § 170.3(o)(8) of this chap- material at NARA, call 202–741–6030, or ter, firming agent as defined in go to: http://www.archives.gov/ § 170.3(o)(10) of this chapter, flavoring federallregister/ agent and adjuvant as defined in codeloflfederallregulations/ § 170.3(o)(12) of this chapter, formula- ibrllocations.html. tion aid as defined in § 170.3(o)(14) of (c) The ingredient is used as a formu- this chapter, humectant as defined in lation aid as defined in § 170.3(o)(14) of § 170.3(o)(16) of this chapter, lubricant this chapter and reducing agent as de- and release agent as defined in fined in § 170.3(o)(22) of this chapter. § 170.3(o)(18) of this chapter, nutritive (d) The ingredient is used in alco- sweetener as defined in § 170.3(o)(21) of holic beverages and table salt in ac- this chapter, sequestrant as defined in cordance with § 184.1(b)(1) at levels not § 170.3(o)(26) of this chapter, stabilizer to exceed good manufacturing practice. and thickener as defined in § 170.3(o)(28) Current good manufacturing practice of this chapter, surface-finishing agent results in a maximum level, as served, as defined in § 170.3(o)(30) of this chap- of 0.00005 percent for alcoholic bev- ter, and texturizer as defined in erages as defined in § 170.3(n)(2) of this § 170.3(o)(32) of this chapter. chapter and 0.1 percent for table salt as (d) The ingredient is used in food at defined in § 170.3(n)(26) of this chapter. levels not to exceed good manufac- (e) Prior sanctions for this ingredient turing practices. Current good manu- different from the uses established in facturing practice in the use of sorbitol this section do not exist or have been results in a maximum level of 99 per- waived. cent in hard candy and cough drops as [43 FR 22938, May 30, 1978, as amended at 49 defined in § 170.3(n)(25) of this chapter, FR 5613, Feb. 4, 1984] 75 percent in chewing gum as defined in § 170.3(n)(6) of this chapter, 98 percent § 184.1835 Sorbitol. in soft candy as defined in § 170.3(n)(38) (a) Sorbitol is the chemical 1,2,3,4,5,6- of this chapter, 30 percent in non- hexanehexol (C6H14O6), a hexahydric al- standardized jams and jellies, commer- cohol, differing from mannitol prin- cial, as defined in § 170.3(n)(28) of this cipally by having a different optical ro- chapter, 30 percent in baked goods and tation. Sorbitol is produced by the baking mixes as defined in § 170.3(n)(1) electrolytic reduction, or the transi- of this chapter, 17 percent in frozen tion metal catalytic hydrogenation of dairy desserts and mixes as defined in sugar solutions containing glucose or § 170.3(n)(20) of this chapter, and 12 per- fructose. cent in all other foods. (b) The ingredient meets the speci- (e) The label and labeling of food fications of the ‘‘Food Chemicals whose reasonably foreseeable consump- Codex,’’ 3d Ed. (1981), p. 308, which is in- tion may result in a daily ingestion of

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50 grams of sorbitol shall bear the § 184.1848 Starter distillate. statement: ‘‘Excess consumption may (a) Starter distillate (butter starter have a laxative effect.’’ distillate) is a steam distillate of the (f) Prior sanctions for this ingredient culture of any or all of the following different from the uses established in species of bacteria grown on a medium this regulation do not exist or have consisting of skim milk usually for- been waived. tified with about 0.1 percent citric acid: [42 FR 14653, Mar. 15, 1977, as amended at 49 Streptococcus lactis, S. cremoris, S. lactis FR 5613, Feb. 14, 1984] subsp. diacetylactis, Leuconostoc citrovorum, and L. dextranicum. The in- § 184.1845 Stannous chloride (anhy- gredient contains more than 98 percent drous and dihydrated). water, and the remainder is a mixture of butterlike flavor compounds. Diace- (a) Stannous chloride is anhydrous or tyl is the major flavor component, con- contains two molecules of water of hy- stituting as much as 80 to 90 percent of dration. Anhydrous stannous chloride the mixture of organic flavor com- (SnCl2, CAS Reg. No. 7772–99–8) is the pounds. Besides diacetyl, starter dis- chloride salt of metallic tin. It is pre- tillate contains minor amounts of acet- pared by reacting molten tin with ei- aldehyde, ethyl formate, ethyl acetate, ther chlorine or gaseous tin tetra- acetone, ethyl alcohol, 2-butanone, chloride. Dihydrated stannous chloride acetic acid, and acetoin. (SnCl2·2H2O, CAS Reg. No. 10025–0969– (b) The ingredient must be of a pu- 091) is the chloride salt of metallic tin rity suitable for its intended use. that contains two molecules of water. (c) In accordance with § 184.1(b)(1), It is prepared from granulated tin sus- the ingredient is used in food with no pended in water and hydrochloric acid limitation other than current good or chlorine. manufacturing practice. The affirma- (b) Both forms of the ingredient meet tion of this ingredient as generally rec- the specifications of the Food Chemi- ognized as safe (GRAS) as a direct cals Codex, 3d Ed. (1981), p. 312, which is human food ingredient is based upon incorporated by reference. Copies are the following current good manufac- available from the National Academy turing practice conditions of use: Press, 2101 Constitution Ave. NW., (1) The ingredient is used as a fla- Washington, DC 20418, or available for voring agent and adjuvant as defined in inspection at the National Archives § 170.3(o)(12) of this chapter. and Records Administration (NARA). (2) The ingredient is used in food at For information on the availability of levels not to exceed current good man- this material at NARA, call 202–741– ufacturing practice. 6030, or go to: http://www.archives.gov/ (d) Prior sanctions for this ingredient federallregister/ different from the uses established in codeloflfederallregulations/ this section do not exist or have been ibrllocations.html. waived. (c) The ingredient is used as an anti- [48 FR 51907, Nov. 15, 1983, as amended at 73 oxidant as defined in § 170.3(o)(3) of this FR 8608, Feb. 14, 2008] chapter. § 184.1851 Stearyl citrate. (d) The ingredient is used in food at levels not to exceed current good man- (a) Stearyl citrate is a mixture of the ufacturing practice in accordance with mono-, di-, and tristearyl esters of cit- § 184.(b)(1). Current good manufacturing ric acid. It is prepared by esterifying practice results in a maximum level, as citric acid with stearyl alcohol. served, of 0.0015 percent or less; cal- (b) The ingredient must be of a pu- culated as tin, for all food categories. rity suitable for its intended use. (e) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from those uses established in the ingredient is used in food with no limitation other than current good this section do not exist or have been manufacturing practice. The affirma- waived. tion of this ingredient as generally rec- [47 FR 27816, June 25, 1982] ognized as safe (GRAS) as a direct

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human food ingredient is based upon or enzymes, followed by refinement and the following current good manufac- crystallization from the resulting hy- turing practice conditions of use: drolysate. (1) The ingredient is used as an anti- (b) The ingredient meets the speci- oxidant as defined in § 170.3(o)(3) of this fications of the Food Chemicals Codex, chapter; an emulsifier and emulsifier 3d Ed. (1981), pp. 97–98 under the head- salt as defined in § 170.3(o)(8) of this ing ‘‘Dextrose,’’ which is incorporated chapter; a sequestrant as defined in by reference in accordance with 5 § 170.3(o)(26) of this chapter; and a sur- U.S.C. 552(a) and 1 CFR part 1. Copies face-active agent as defined in are available from the National Acad- § 170.3(o)(29) of this chapter. emy Press, 2101 Constitution Ave., NW., (2) The ingredient is used in mar- Washington, DC 20418, or available for garine in accordance with § 166.110 of inspection at the National Archives this chapter; in nonalcoholic beverages and Records Administration (NARA). as defined in § 170.3(n)(3) of this chap- For information on the availability of ter; and in fats and oils as defined in this material at NARA, call 202–741– § 170.3(n)(12) of this chapter at levels 6030, or go to: http://www.archives.gov/ not to exceed current good manufac- federallregister/ turing practice. codeloflfederallregulations/ (d) Prior sanctions for this ingredient ibrllocations.html. different from the uses established in (c) In accordance with § 184.1(b)(1), this section, or different from those set the ingredient is used in food with no forth in part 181 of this chapter, do not limitation other than current good exist or have been waived. manufacturing practice. (d) Prior sanctions for this ingredient [59 FR 63897, Dec. 12, 1994, as amended at 73 FR 8608, Feb. 14, 2008] different from the uses established in this section do not exist or have been § 184.1854 Sucrose. waived.

(a) Sucrose (C12H22O11, CAS Reg. No. [53 FR 44876, Nov. 7, 1988] 57–50–11–1) sugar, cane sugar, or beet sugar is the chemical b-D- § 184.1859 Invert sugar. fructofuranosyl-a-D-glucopyranoside. (a) Invert sugar (CAS Reg. No. 8013– Sucrose is obtained by crystallization 17–0) is an aqueous solution of inverted from sugar cane or sugar beet juice or partly inverted, refined or partly re- that has been extracted by pressing or fined sucrose, the solids of which con- diffusion, then clarified and evapo- tain not more than 0.3 percent by rated. weight of ash. The solution is colorless, (b) The ingredient must be of a pu- odorless, and flavorless, except for rity suitable for its intended use. sweetness. It is produced by the hydrol- (c) In accordance with § 184.1(b)(1), ysis or partial hydrolysis of sucrose the ingredient is used in food with no with safe and suitable acids or en- limitation other than current good zymes. manufacturing practice. (b) The ingredient must be of a pu- (d) Prior sanctions for this ingredient rity suitable for its intended use. different from the uses established in (c) In accordance with § 184.1(b)(1), this section do not exist or have been the ingredient is used in food with no waived. limitation other than current good manufacturing practice. [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, 1989, as amended at 73 FR 8608, Feb. 14, 2008] (d) Prior sanctions for this ingredient different from the uses established in § 184.1857 Corn sugar. this section do not exist or have been waived. (a) Corn sugar (C6H12O6, CAS Reg. No. 50–99–7), commonly called D-glucose or [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, dextrose, is the chemical a-D- 1989, as amended at 73 FR 8608, Feb. 14, 2008] glucopyranose. It occurs as the anhydrous or the monohydrate form and is § 184.1865 Corn syrup. produced by the complete hydrolysis of (a) Corn syrup, commonly called corn starch with safe and suitable acids ‘‘glucose sirup’’ or ‘‘glucose syrup,’’ is

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obtained by partial hydrolysis of corn go to: http://www.archives.gov/ starch with safe and suitable acids or federallregister/ enzymes. It may also occur in the de- codeloflfederallregulations/ hydrated form (dried glucose sirup). ibrllocations.html. Depending on the degree of hydrolysis, (c) In accordance with § 184.1(b)(1), corn syrup may contain, in addition to the ingredient is used in food with no glucose, maltose and higher limitation other than current good saccharides. manufacturing practice. (b) The ingredient meets the speci- [61 FR 43450, Aug.23, 1996] fications as defined and determined in § 168.120(b) or § 168.121(a) of this chapter, § 184.1875 Thiamine hydrochloride. as appropriate. (a) Thiamine hydrochloride (c) In accordance with § 184.1(b)(1), (C H C1N OS·HCl, CAS Reg. No. 67–03– the ingredient is used in food with no 12 17 4 8) is the chloride-hydrochloride salt of limitation other than current good thiamine. It occurs as hygroscopic manufacturing practice. (d) Prior sanctions for this ingredient white crystals or a white crystalline different from the uses established in powder. The usual method of preparing this section do not exist or have been this substance is by linking the waived. preformed thiazole and pyrimidine ring systems. [53 FR 44876, Nov. 7, 1988, as amended at 73 (b) The ingredient meets the speci- FR 8608, Feb. 14, 2008] fications of the Food Chemicals Codex, 3d Ed. (1981), p. 324, which is incor- § 184.1866 High fructose corn syrup. porated by reference. Copies are avail- (a) High fructose corn syrup, a sweet, able from the National Academy Press, nutritive saccharide mixture con- 2101 Constitution Ave. NW., Wash- taining either approximately 42 or 55 ington, DC 20418, or available for in- percent fructose, is prepared as a clear spection at the National Archives and aqueous solution from high dextrose- Records Administration (NARA). For equivalent corn starch hydrolysate by information on the availability of this partial enzymatic conversion of glu- material at NARA, call 202–741–6030, or cose (dextrose) to fructose using an in- go to: http://www.archives.gov/ soluble glucose isomerase enzyme prep- federallregister/ aration described in § 184.1372. The codeloflfederallregulations/ product containing more than 50 per- ibrllocations.html. cent fructose (dry weight) is prepared (c) In accordance with § 184.1(b)(1), through concentration of the fructose the ingredient is used in food with no portion of the mixture containing less limitation other than current good than 50 percent fructose. manufacturing practice. The affirma- (b) The ingredient shall conform to tion of this ingredient as generally rec- the identity and specifications listed in ognized as safe (GRAS) as a direct the monograph entitled ‘‘High-Fruc- human food ingredient is based upon tose Corn Syrup’’ in the Food Chemi- the following current good manufac- cals Codex, 4th ed. (1996), pp. 191–192, turing practice conditions of use: which is incorporated by reference in (1) The ingredient is used as a fla- accordance with 5 U.S.C. 552(a) and 1 voring agent and adjuvant as defined in CFR part 51. Copies are available from § 170.3(o)(12) of this chapter or as a nu- the Office of Premarket Approval, Cen- trient supplement as defined in ter for Food Safety and Applied Nutri- § 170.3(o)(20) of this chapter. tion (HFS–200), Food and Drug Admin- (2) The ingredient is used in food at istration, 5100 Paint Branch Pkwy., levels not to exceed current good man- College Park, MD 20740, or may be ex- ufacturing practice. Thiamine hydro- amined at the Center for Food Safety chloride may be used in infant formula and Applied Nutrition’s Library, 5100 in accordance with section 412(g) of the Paint Branch Pkwy., College Park, MD Federal Food, Drug, and Cosmetic Act 20740, or at the National Archives and (the Act) or with regulations promul- Records Administration (NARA). For gated under section 412(a)(2) of the Act. information on the availability of this (d) Prior sanctions for this ingredient material at NARA, call 202–741–6030, or different from the uses established in

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this section do not exist or have been § 184.1890 ù-Tocopherols. waived. (a) The a-tocopherols that are the [48 FR 55124, Dec. 9, 1983] subject of this GRAS affirmation regulation are limited to the following: § 184.1878 Thiamine mononitrate. (1) d-a-Tocopherol (CAS Reg. No. 59– (a) Thiamine mononitrate 02–9) is the chemical [2R,4′R,8prime;R]- 2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyl- (C12H17N5O4S, CAS Reg. No. 532–43–4) is the mononitrate salt of thiamine. It tridecyl)-6-chromanol. It occurs com- occurs as white crystals or a white mercially as a concentrate and is a red, crystalline powder and is prepared nearly odorless, viscous oil. It is ob- from thiamine hydrochloride by dis- tained by vacuum steam distillation of solving the hydrochloride salt in alka- edible vegetable oil products. line solution followed by precipitation (2) dl-a-Tocopherol (CAS Reg. No. of the nitrate half-salt with a stoichio- 10191–41–0) is a mixture of metric amount of nitric acid. stereoisomers of 2,5,7,8-tetramethyl-2- (4′,8′,12′-trimethyl-tridecyl)-6- (b) The ingredient meets the speci- chromanol. It is chemically syn- fications of the Food Chemicals Codex, thesized by condensing racemic 3d Ed. (1981), p. 325, which is incor- isophytol with trimethyl hydro- porated by reference. Copies are avail- quinone. It is a pale yellow viscous oil able from the National Academy Press, at room temperature. 2101 Constitution Ave. NW., Wash- (b) The ingredients meet the speci- ington, DC 20418, or available for in- fications of the Food Chemicals Codex, spection at the National Archives and 3d Ed. (1981), pp. 330–331, which is incor- Records Administration (NARA). For porated by reference. Copies are avail- information on the availability of this able from the National Academy Press, material at NARA, call 202–741–6030, or 2101 Constitution Ave. NW., Wash- go to: http://www.archives.gov/ ington, DC 20418, or available for in- federallregister/ spection at the National Archives and codeloflfederallregulations/ Records Administration (NARA). For ibrllocations.html. information on the availability of this (c) In accordance with § 184.1(b)(1), material at NARA, call 202–741–6030, or the ingredient is used in food with no go to: http://www.archives.gov/ limitation other than current good federallregister/ manufacturing practice. The affirma- codeloflfederallregulations/ tion of this ingredient as generally rec- ibrllocations.html. ognized as safe (GRAS) as a direct (c) In accordance with § 184.1(b)(3), human food ingredient is based upon the affirmation of the ingredients as the following current good manufac- generally recognized as safe is limited turing practice conditions of use: to the following conditions of use while the agency concludes the general eval- (1) The ingredient is used as a nutri- uation of all food uses of tocopherols: ent supplement as defined in (1) The ingredients are used as inhibi- § 170.3(o)(20) of this chapter. tors of nitrosamine formation. (2) The ingredient is used in food at (2) The ingredients are used in pump- levels not to exceed current good man- cured bacon at levels not to exceed cur- ufacturing practice. Thiamine mono- rent good manufacturing practice. nitrate may be used in infant formula in accordance with section 412(g) of the [49 FR 13348, Apr. 4, 1984] Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promul- § 184.1901 Triacetin. gated under section 412(a)(2) of the Act. (a) Triacetin (C8 H14O6, CAS Reg. No. (d) Prior sanctions for this ingredient 102–76–1), also known as 1,2,3,- different from the uses established in propanetriol triacetate or glyceryl this section do not exist or have been triacetate, is the triester of glycerin waived. and acetic acid. Triacetin can be prepared by heating glycerin with acetic [48 FR 55124, Dec. 9, 1983] anhydride alone or in the presence of

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finely divided potassium hydrogen sul- (d) Prior sanctions for this ingredient fate. It can also be prepared by the re- different from the uses established in action of oxygen with a liquid-phase this section do not exist or have been mixture of allyl acetate and acetic acid waived. using a bromide salt as a catalyst. [54 FR 7404, Feb. 21, 1989] (b) The ingredient meets the specifications of the Food Chemicals Codex, § 184.1903 Tributyrin. 3d Ed. (1981), pp. 337–338, as revised by the First Supplement to the 3d Ed., (a) Tributyrin (C15H26O6, CAS Reg. which is incorporated by reference in No. 60–01–5), also known as butyrin or accordance with 5 U.S.C. 552(a). Copies glyceryl tributyrate, is the triester of are available from the National Acad- glycerin and butyric acid. It is pre- emy Press, 2102 Constitution Ave., NW., pared by esterification of glycerin with Washington, DC 20418, or available for excess butyric acid. inspection at the National Archives (b) The ingredient meets the speci- and Records Administration (NARA). fication of the Food Chemicals Codex, For information on the availability of 3d Ed. (1981), p. 416, which is incor- this material at NARA, call 202–741– porated by reference in accordance 6030, or go to: http://www.archives.gov/ with 5 U.S.C. 552(a). Copies are avail- federallregister/ able from the National Academy Press, codeloflfederallregulations/ 2101 Constitution Ave. NW., Wash- ibrllocations.html. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(1), spection at the National Archives and the ingredient is used in food with no Records Administration (NARA). For limitation other than current good information on the availability of this manufacturing practice. The affirma- material at NARA, call 202–741–6030, or tion of this ingredient as generally rec- go to: http://www.archives.gov/ ognized as safe (GRAS) as a direct federallregister/ human food ingredient is based upon codeloflfederallregulations/ the following current good manufac- ibrllocations.html. turing practice conditions of use: (c) In accordance with § 184.1(b)(1), (1) The ingredient is used in food as a the ingredient is used in food with no flavoring agent and adjuvant as defined limitation other than current good in § 170.3(o)(12) of this chapter; a formu- manufacturing practice. The affirma- lation aid as defined in § 170.3(o)(14) of tion of this ingredient as generaly rec- this chapter; and humectant as defined ognized as safe (GRAS) as a direct in § 170.3(o)(16) of this chapter; and a human food ingredient is based upon solvent and vehicle as defined in the following current good manufac- § 170.3(o)(27) of this chapter. turing practice conditions of use: (2) The ingredient is used in the fol- (1) The ingredient is used in food as a lowing foods at levels not to exceed flavoring agent and adjuvant as defined current good manufacturing practice: in § 170.3(o)(12) of this chapter. baked goods and baking mixes as de- (2) The ingredient is used in the fol- fined in § 170.3(n)(1) of this chapter, al- lowing foods at levels not to exceed coholic beverages as defined in current good manufacturing practice; § 170.3(n)(2) of this chapter; non- baked goods as defined in § 170.3(n)(1) of alcoholic beverages and beverage bases this chapter; alcoholic beverages as de- as defined in § 170.3(n)(3) of this chap- fined in § 170.3(n)(2) of this chapter; ter; chewing gum as defined in nonalcoholic beverages as defined in § 170.3(n)(6) of this chapter; confections § 170.3(n)(3) of this chapter; fats and oils and frostings as defined in § 170.3(n)(9) as defined in § 170.3(n)(12) of this chap- of this chapter; frozen dairy dessert ter; frozen dairy desserts and mixes as and mixes as defined in § 170.3(n)(20) of defined in § 170.3(n)(20) of this chapter; this chapter; gelatins, puddings, and gelatins, puddings and fillngs as de- fillngs as defined in § 170.3(n)(22) of this fined in § 170.3(n)(22) of this chapter; chapter; hard candy as defined in and soft candy as defined in § 170.3(n)(25) of this chapter; and soft § 170.3(n)(38) of this chapter. candy as defined in § 170.3(n)(38) of this (d) Prior sanctions for this ingredient chapter. different from the uses established in

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this section do not exist or have been § 184.1914 Trypsin. waived. (a) Trypsin (CAS Reg. No. 9002–07–7) [54 FR 7404, Feb. 21, 1989; 54 FR 10482, Mar. 13, is an enzyme preparation obtained 1989] from purified extracts of porcine or bovine pancreas. It is a white to tan § 184.1911 Triethyl citrate. amorphous powder. Its characterizing enzyme activity is that of a peptide hy- (a) Triethyl citrate (C12H20O7, CAS Reg. No. 77–93–0) is the triethyl ester of drolase (EC 3.4.21.4). citric acid. It is prepared by esterifying (b) The ingredient meets the general requirements and additional require- citric acid with ethyl alcohol and oc- ments for enzyme preparations in the curs as an odorless, practically color- Food Chemicals Codex, 3d ed. (1981), p. less, oily liquid. 110, which is incorporated by reference (b) The ingredient meets the speci- in accordance with 5 U.S.C. 552(a) and 1 fications of the Food Chemicals Codex, CFR part 51. Copies are available from 3d ed. (1981), p. 339, which is incor- the National Academy Press, 2101 Con- porated by reference in accordance stitution Ave. NW., Washington, DC with 5 U.S.C. 552(a) and 1 CFR part 51. 20418, or may be examined at the Office Copies are available from the National of Premarket Approval (HFS–200), Food Academy Press, 2101 Constitution Ave. and Drug Administration, 5100 Paint NW., Washington, DC 20418, and the Branch Pkwy., College Park, MD 20740, Center for Food Safety and Applied Nu- and at the National Archives and trition (HFS–200), 5100 Paint Branch Records Administration (NARA). For Pkwy., College Park, MD 20740, or may information on the availability of this be examined at the National Archives material at NARA, call 202–741–6030, or and Records Administration (NARA). go to: http://www.archives.gov/ For information on the availability of federallregister/ this material at NARA, call 202–741– codeloflfederallregulations/ 6030, or go to: http://www.archives.gov/ ibrllocations.html. federallregister/ (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no codeloflfederallregulations/ limitation other than current good ibrllocations.html. manufacturing practice. The affirma- (c) In accordance with § 184.1(b)(1), tion of this ingredient as GRAS as a di- the ingredient is used in food with no rect food ingredient is based upon the limitation other than current good following current good manufacturing manufacturing practice. The affirma- practice conditions of use: tion of this ingredient as generally rec- (1) The ingredient is used as an en- ognized as safe (GRAS) as a direct zyme as defined in § 170.3(o)(9) of this human food ingredient is based upon chapter to hydrolyze proteins or the following current good manufac- polypeptides. turing practice conditions of use: (2) The ingredient is used in food at (1) The ingredient is used as a fla- levels not to exceed current good man- voring agent as defined in § 170.3(o)(12) ufacturing practice. of this chapter; a solvent and vehicle as [60 FR 32911, June 26, 1995] defined in § 170.3(o)(27) of this chapter; and a surface-active agent as defined in § 184.1923 Urea. § 170.3(o)(29) of this chapter. (a) Urea (CO(NH2)2, CAS Reg. No. 57– (2) The ingredient is used in foods at 13–6) is the diamide of carbonic acid levels not to exceed current good man- and is also known as carbamide. It is a ufacturing practice. white, odorless solid and is commonly (d) Prior sanctions for this ingredient produced from CO2 by ammonolysis or different from the uses established in from cyanamide by hydrolysis. this section, or different from those set (b) The ingredient must be of a pu- forth in part 181 of this chapter, do not rity suitable for its intended use. exist or have been waived. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no [59 FR 63897, Dec. 12, 1994] limitation other than current good

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manufacturing practice. The affirma- upon the following current good manu- tion of this ingredient as generally rec- facturing practice conditions of use: ognized as safe as a direct human food (1) The ingredient is used in wine, as ingredient is based upon the following defined in 27 CFR 2.5 and 4.10, as an en- current good manufacturing practice zyme as defined in § 170.3(o)(9) of this conditions of use: chapter to convert urea to ammonia (1) The ingredient is used as a formu- and carbon dioxide. lation aid as defined in § 170.3(o)(14) of (2) The ingredient is used in food at this chapter and as a fermentation aid. levels not to exceed current good man- (2) The ingredient is used in yeast- ufacturing practice. Current good man- raised bakery products; in alcoholic ufacturing practice is limited to use of beverages as defined in § 170.3(n)(2) of this ingredient in wine to inhibit for- this chapter; and in gelatin products. mation of ethyl carbamate. (d) Prior sanctions for this ingredient different from the uses established in [57 FR 60473, Dec. 21, 1992] this section do not exist or have been waived. § 184.1930 Vitamin A. (a)(1) Vitamin A (retinol; CAS Reg. [48 FR 51616, Nov. 10, 1983, as amended at 49 FR 19816, May 10, 1984; 73 FR 8608, Feb. 14, No. 68–26–8) is the alcohol 9,13-di- 2008] methyl-7-(1,1,5-trimethyl-6-cyclohexen- 5-yl)-7,9,11,13-nonatetraen-15-ol. It may § 184.1924 Urease enzyme preparation be nearly odorless or have a mild fishy from Lactobacillus fermentum. odor. Vitamin A is extracted from fish (a) This enzyme preparation is de- liver oils or produced by total syn- rived from the nonpathogenic, thesis from b-ionone and a propargyl nontoxicogenic bacterium Lactobacillus halide. fermentum. It contains the enzyme (2) Vitamin A acetate (retinyl ace- urease (CAS Reg. No. 9002–13–5), which tate; CAS Reg. No. 127–47–9) is the ace- facilitates the hydrolysis of urea to tate ester of retinol. It is prepared by ammonia and carbon dioxide. It is pro- esterifying retinol with acetic acid. duced by a pure culture fermentation (3) Vitamin A palmitate (retinyl process and by using materials that are palmitate; CAS Reg. No. 79–81–2) is the generally recognized as safe (GRAS) or palmitate ester of retinol. It is pre- are food additives that have been ap- pared by esterifying retinol with pal- proved for this use by the Food and mitic acid. Drug Administration (FDA). (b) The ingredient meets the speci- (b) The ingredient meets the general fications for vitamin A in the Food and additional requirements for en- Chemicals Codex, 3d Ed. (1981), p. 342, zyme preparations in the ‘‘Food Chemi- which is incorporated by reference. cals Codex,’’ 3d ed. (1981), pp. 107–110, Copies are available from the National which is incorporated by reference in Academy Press, 2101 Constitution Ave. accordance with 5 U.S.C. 552(a) and 1 NW., Washington, DC 20418, or avail- CFR part 51. Copies are available from able for inspection at the National Ar- the National Academy Press, 2101 Con- chives and Records Administration stitution Ave. NW., Washington, DC (NARA). For information on the avail- 20418, or available for inspection at the ability of this material at NARA, call National Archives and Records Admin- 202–741–6030, or go to: http:// istration (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/ (c) In accordance with § 184.1(b)(1), codeloflfederallregulations/ the ingredient is used in food with no ibrllocations.html. limitation other than current good (c) In accordance with § 184.1(b)(1), manufacturing practice. The affirma- the ingredient is used in food with no tion of this ingredient as generally rec- limitation other than current good ognized as safe (GRAS) as a direct manufacturing practice. The affirma- human food ingredient is based upon tion of this ingredient as GRAS as a di- the following current good manufac- rect human food ingredient is based turing practice conditions of use:

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(1) The ingredient is used in food as a (d) Prior sanctions for this ingredient nutrient supplement as defined in different from the uses established in § 170.3(o)(20) of this chapter. this section do not exist or have been (2) The ingredient is used in foods at waived. levels not to exceed current good man- [50 FR 6341, Feb. 15, 1985] ufacturing practice. Vitamin A may be used in infant formula in accordance § 184.1950 Vitamin D. with section 412(g) of the Federal Food, (a) Vitamin D is added to food as the Drug, and Cosmetic Act (the act) or following food ingredients: with regulations promulgated under (1) Crystalline vitamin D2 (C28H44O, section 412(a)(2) of the Act. CAS Reg. No. 50–14–6), also known as (d) Prior sanctions for this ingredient ergocalciferol, is the chemical 9,10- different from the uses established in seco(5Z,7E,22E)-5,7,10(19),22- this section do not exist or have been ergostatetraen-3-ol. The ingredient is waived. produced by ultraviolet irradiation of [48 FR 51610, Nov. 10, 1983] ergosterol isolated from yeast and related fungi and is purified by crys-

§ 184.1945 Vitamin B12. tallization. (2) Crystalline vitamin D (C H O, (a) Vitamin B , also known as cyano- 3 27 44 12 CAS Reg. No. 67–97–0), also known as cobalamin (C H CoN O P, CAS Reg. 63 88 14 14 cholecalciferol, is the chemical 9,10- No. 68–0919–099), is produced commer- seco(5Z,7E,)-5,7,10(19)-cholestatrien-3- cially from cultures of Streptomyces ol. Vitamin D3 occurs in, and is iso- griseus. lated from, fish liver oils. It is also (b) The ingredient meets the speci- manufactured by ultraviolet irradia- fications of the Food Chemicals Codex, tion of 7-dehydrocholesterol produced 3d Ed. (1981), p. 343, which is incor- from cholesterol. It is purified by crys- porated by reference. Copies are avail- tallization. Vitamin D3 is the vitamin able from the National Academy Press, D form that is produced endogenously 2101 Constitution Ave. NW., Wash- in humans through sunlight activation ington, DC 20418, or available for in- of 7-dehydrocholesterol in the skin. spection at the National Archives and (3) Vitamin D2 resin and vitamin D3 Records Administration (NARA). For resin are the concentrated forms of ir- information on the availability of this radiated ergosterol (D2) and irradiated material at NARA, call 202–741–6030, or 7-dehydrocholesterol (D3) that are sepa- go to: http://www.archives.gov/ rated from the reacting materials in federallregister/ paragraphs (a) (1) and (2) of this sec- codeloflfederallregulations/ tion. The resulting products are sold as ibrllocations.html. food sources of vitamin D without fur- (c) In accordance with § 184.1(b)(1), ther purification. the ingredient is used in food with no (b) Vitamin D2 and vitamin D3 as limitation other than current good crystals meet the specifications of the manufacturing practice. The affirma- Food Chemicals Codex, 3d Ed. (1981), tion of this ingredient as generally rec- pp. 344 and 345, which is incorporated ognized as safe (GRAS) as a direct by reference. Copies are available from human food ingredient is based upon the National Academy Press, 2101 Con- the following current good manufac- stitution Ave. NW., Washington, DC turing practice conditions of use: 20418, or available for inspection at the (1) The ingredient is used as a nutri- National Archives and Records Admin- ent supplement as defined in istration (NARA). For information on § 170.3(o)(20) of this chapter. the availability of this material at (2) The ingredient is used in food at NARA, call 202–741–6030, or go to: http:// levels not to exceed current good man- www.archives.gov/federallregister/ ufacturing practice. Vitamin B12 also codeloflfederallregulationsll may be used in infant formula in ac- ibrllocations.html. Vitamin D2 resin cordance with section 412(g) of the Fed- and vitamin D3 resin must be of a pu- eral Food, Drug, and Cosmetic Act (the rity suitable for their intended use. act) or with regulations promulgated (c)(1) In accordance with § 184.1(b)(2), under section 412(a)(2) of the act. the ingredients are used in food as the

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sole source of added vitamin D only information on the availability of this within the following specific limita- material at NARA, call 202–741–6030, or tions: go to: http://www.archives.gov/ federallregister/ Maximum levels in Category of food food (as served) Functional use codeloflfederallregulations/ ibrllocations.html. Breakfast cereals, 350 (IU/100 Nutrient supple- § 170.3(n)(4) of grams). ment, (c) The ingredient is used as a fla- this chapter. § 170.3(o)(20) of voring agent and adjuvant as defined in this chapter. § 170.3(o)(12) of this chapter, as a lubri- Grain products and 90(IU/100 grams) Do. cant as defined in § 170.3(o)(18) of this pastas, § 170.3(n)(23) of chapter, and as a surface-finishing this chapter. agent as defined in § 170.3(o)(30) of this Milk, § 170.3(n)(30) 42 (IU/100 grams) Do. chapter. of this chapter. Milk products, 89 (IU/100 grams) Do. (d) The ingredient is used in food, in § 170.3(n)(31) of accordance with § 184.1(b)(1) of this this chapter. chapter, at levels not to exceed good manufacturing practice. Current good (2) Vitamin D may be used in infant manufacturing practice results in a formula in accordance with section maximum level, as served, of: 0.065 per- 412(g) of the Federal Food, Drug, and cent for chewing gum as defined in Cosmetic Act (the act) or with regula- § 170.3(n)(6) of this chapter; 0.005 per- tions promulgated under section cent for confections and frostings as 412(a)(2) of the act. (3) Vitamin D may be used in mar- defined in § 170.3(n)(9) of this chapter; garine in accordance with § 166.110 of 0.04 percent for hard candy as defined this chapter. in § 170.3(n)(25) of this chapter; 0.1 per- (d) Prior sanctions for these ingredi- cent for soft candy as defined in ents different from the uses established § 170.3(n)(38) of this chapter; and 0.002 in this section do not exist or have percent or less for all other food cat- been waived. egories. [50 FR 30152, July 24, 1985, as amended at 73 [43 FR 14644, Apr. 7, 1978, as amended at 49 FR 8608, Feb. 14, 2008] FR 5613, Feb. 14, 1984; 50 FR 49536, Dec. 3, 1985] § 184.1973 Beeswax (yellow and white). § 184.1976 Candelilla wax. (a) Beeswax (CAS Reg. No. 8012–89–3) is a secretory product of honey bees (a) Candelilla wax (CAS Reg. No. used as a structural material in honey- 8006–44–8) is obtained from the can- combs. Beeswax is prepared from hon- delilla plant. It is a hard, yellowish- eycombs after removal of the honey by brown, opaque-to-translucent wax. draining or centrifuging. The combs Candelilla wax is prepared by immers- are melted in hot water or steam or ing the plants in boiling water con- with solar heat, and strained. The wax taining sulfuric acid and skimming off is refined by melting in hot water to the wax that rises to the surface. It is which sulfuric acid or alkali may be composed of about 50 percent hydro- added to extract impurities. The re- carbons with smaller amounts of esters sulting wax is referred to as yellow and free acids. beeswax. White beeswax is produced by (b) The ingredient meets the speci- bleaching the constituent pigments of fications of the Food Chemicals Codex, yellow beeswax with peroxides, or pref- 3d Ed. (1981), p. 67, which is incor- erably it is bleached by sun light. porated by reference. Copies are avail- (b) The ingredient meets the speci- able from the National Academy Press, fications of the ‘‘Food Chemicals 2101 Constitution Ave. NW., Wash- Codex,’’ 3d Ed. (1981), pp. 34–35, which is ington, DC 20418, or available for in- incorporated by reference. Copies may spection at the National Archives and be obtained from the National Acad- Records Administration (NARA). For emy Press, 2101 Constitution Ave. NW., information on the availability of this Washington, DC 20418, or may be exam- material at NARA, call 202–741–6030, or ined at the National Archives and go to: http://www.archives.gov/ Records Administration (NARA). For federallregister/

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codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (c) In accordance with § 184.1(b)(1), (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no the ingredient is used in food with no limitation other than current good limitation other than current good manufacturing practice. The affirma- manufacturing practice. The affirmation of this ingredient as generally rec- tion of this ingredient as generally recognized as safe (GRAS) as a direct ognized as safe (GRAS) as a direct human food ingredient is based upon human food ingredient is based upon the following current good manufac- the following current good manufacturing practice conditions of use: turing practice conditions of use: (1) The ingredient is used as a lubri- (1) The ingredient is used as an cant as defined in § 170.3(o)(18) of this anticaking agent as defined § 170.3(o)(1) chapter and as a surface-finishing of this chapter; as a formulation aid as agent as defined in § 170.3(o)(30) of this defined in § 170.3(o)(14) of this chapter; chapter. as a lubricant and release agent as de- (2) The ingredient is used in the fol- fined in § 170.3(o)(18) of this chapter; lowing foods at levels not to exceed and as a surface-finishing agent as de- current good manufacturing practice: fined in § 170.3(o)(30) of this chapter. in chewing gum as defined in (2) The ingredient is used in the fol- § 170.3(n)(6) of this chapter and in hard lowing foods at levels not to exceed candy as defined in § 170.3(n)(25) of this current good manufacturing practice: baked goods and baking mixes as de- chapter. fined in § 170.3(n)(1) of this chapter; (d) Prior sanctions for this ingredient chewing gun as defined in § 170.3(n)(6) of different from the uses established in this chapter; confections and frostings this section do not exist or have been as defined in § 170.3(n)(9) of this chap- waived. ter; fresh fruits and fruit juices as de- [48 FR 51617, Nov. 10, 1983] fined in § 170.3(n)(16) of this chapter; gravies and sauces as defined in § 184.1978 Carnauba wax. § 170.3(n)(24) of this chapter; processed (a) Carnauba wax (CAS Reg. No. 008– fruits and fruit juices as defined in 015–869) is obtained from the leaves and § 170.3(n)(35) of this chapter; and soft buds of the Brazilian wax palm candy as defined in § 170.3(n)(38) of this Copernicia cerifera Martius. The wax is chapter. hard, brittle, sparingly soluble in cold (d) Prior sanctions for this ingredient organic solvents and insoluble in different from the uses established in water. It is marketed in five grades this section do not exist or have been designated No. 1 through No. 5. Grades waived. No. 4 and No. 5 represent the bulk of [48 FR 51147, Nov. 7, 1983] the commercial trade volume. These commercial grades consist chiefly of § 184.1979 Whey. C24 to C32 normal saturated (a)(1) Whey. Whey is the liquid sub- monofunctional fatty acids and normal stance obtained by separating the co- saturated monofunctional primary al- agulum from milk, cream, or skim cohols. milk in cheesemaking. Whey obtained (b) The ingredient meets the speci- from a procedure, in which a signifi- fications of the Food Chemicals Codex, cant amount of lactose is converted to 3d Ed. (1981), p. 73, which is incor- lactic acid, or from the curd formation porated by reference. Copies are avail- by direct acidification of milk, is able from the National Academy Press, known as acid whey. Whey obtained 2101 Constitution Ave. NW., Wash- from a procedure in which there is in- ington, DC 20418, or available for in- significant conversion of lactose to lac- spection at the National Archives and tic acid is known as sweet whey. Sweet Records Administration (NARA). For whey has a maximum titratable acid- information on the availability of this ity of not more than 0.16 percent, cal- material at NARA, call 202–741–6030, or culated as lactic acid, and an alka- go to: http://www.archives.gov/ linity of ash of not more than 225 milli- federallregister/ liters of 0.1N hydrochloric acid per 100

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grams. The acidity of whey, sweet or 16.199 (dry sample), entitled ‘‘Fat in acid, may be adjusted by the addition Dried Milk (45)—Official Final Action.’’ of safe and suitable pH-adjusting ingre- (iii) Ash content, 7 to 14 percent—as dients. determined by the methods prescribed (2) Concentrated whey. Concentrated in section 16.035 (liquid sample), enti- whey is the liquid substance obtained tled ‘‘Ash (5)—Official Final Action’’ by the partial removal of water from under the heading ‘‘Total Solids,’’ or in whey, while leaving all other constitu- section 16.196 (dry sample), entitled ents in the same relative proportions ‘‘Ash—Official Final Action’’ under the as in whey. heading ‘‘Dried Milk, Nonfat Dry Milk, (3) Dry or dried whey. Dry or dried and Malted Milk.’’ whey is the dry substance obtained by (iv) Lactose content, 61 to 75 per- the removal of water from whey, while cent—as determined by the methods leaving all other constituents in the prescribed in section 16.057 (liquid sam- same relative proportions as in whey. ple), entitled ‘‘Gravimetric Method— (b) The ingredients meet the fol- Official Final Action’’ under the head- lowing specifications: ing ‘‘Lactose,’’ or in section 31.061 (dry sample), entitled ‘‘Lane-Eynon General (1) The analysis of whey, con- Volumetric Method’’ under the heading centrated whey, and dry (dried) whey, ‘‘Lactose—Chemical Methods—Official on a dry product basis, based on ana- Final Action.’’ lytical methods in the referenced sec- (v) Moisture content, 1 to 8 percent— tions of ‘‘Official Methods of Analysis as determined by the methods pre- of the Association of Official Analyt- scribed in section 16.192, entitled ical Chemists,’’ 13th ed. (1980), which is ‘‘Moisture (41)—Official Final Action’’ incorporated by reference in accord- under the heading ‘‘Dried Milk, Nonfat ance with 5 U.S.C. 552(a) and 1 CFR Dry Milk, and Malted Milk.’’ part 51, is given in paragraphs (b)(1)(i) (vi) Solids content, variable—as de- through (b)(1)(vii) of this section. Cop- termined by the methods prescribed in ies may be obtained from the AOAC section 16.032, entitled ‘‘Method I—Offi- INTERNATIONAL, 481 North Frederick cial Final Action’’ under the heading Ave., suite 500, Gaithersburg, MD 20877, ‘‘Total Solids.’’ or may be examined at the Center for (vii) Titratable Acidity, variable—as Food Safety and Applied Nutrition’s determined by the methods prescribed Library, Food and Drug Administra- in section 16.023, entitled ‘‘Acidity (2)— tion, 5100 Paint Branch Pkwy., College Official Final Action’’ under the head- Park, MD 20740, or at the National Ar- ing ‘‘Milk,’’ or by an equivalent poten- chives and Records Administration tiometric method. (NARA). For information on the avail- (2) Limits of impurities are: Heavy ability of this material at NARA, call metals (as lead). Not more than 10 202–741–6030, or go to: http:// parts per million (0.001 percent) as de- www.archives.gov/federallregister/ termined by the method described in codeloflfederallregulations/ the ‘‘Food Chemicals Codex,’’ 4th ed. ibrllocations.html. (1996), pp. 760–761, which is incorporated (i) Protein content, 10 to 15 percent— by reference in accordance with 5 as determined by the methods pre- U.S.C. 552(a) and 1 CFR part 51. Copies scribed in section 16.036 (liquid sample), are available from the National Acad- entitled ‘‘Total Nitrogen—Official emy Press, Box 285, 2101 Constitution Final Action’’ under the heading Ave. NW., Washington, DC 20055 (Inter- ‘‘Total Solids,’’ or in section 16.193 (dry net address http://www.nap.edu), or may sample), entitled ‘‘Kjeldahl Method’’ be examined at the Center for Food under the heading ‘‘Protein—Official Safety and Applied Nutrition’s Li- Final Action.’’ brary, Food and Drug Administration, (ii) Fat content, 0.2 to 2.0 percent—as 5100 Paint Branch Pkwy., College Park, determined by the methods prescribed MD 20740, or at the National Archives in section 16.059 (liquid sample), and Records Administration (NARA). ‘‘Reese-Gottlieb Method [Reference For information on the availability of Method] (11)—Official Final Action’’ this material at NARA, call 202–741– under the heading ‘‘Fat,’’ or in section 6030, or go to: http://www.archives.gov/

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federallregister/ INTERNATIONAL, 481 North Frederick codeloflfederallregulations/ Ave., suite 500, Gaithersburg, MD 20877, ibrllocations.html. or may be examined at the Center for (3) The whey must be derived from Food Safety and Applied Nutrition’s milk that has been pasteurized, or the Library, Food and Drug Administra- whey and modified whey product must tion, 5100 Paint Branch Pkwy., College be subjected to pasteurization tech- Park, MD 20740, or at the National Ar- niques or its equivalent before use in chives and Records Administration food. (NARA). For information on the avail- (c) Whey, concentrated whey, and dry ability of this material at NARA, call (dried) whey may be used in food in ac- 202–741–6030, or go to: http:// cordance with good manufacturing www.archives.gov/federallregister/ practice as indicated in § 184.1(b)(1). codeloflfederallregulations/ (d) The label on the whey form sold ibrllocations.html. to food manufacturers shall read as fol- (i) Protein content, 16 to 24 percent— lows: as determined by the methods pre- (1) For whey: ‘‘(Sweet or acid) whey’’ scribed in section 16.036 (liquid sample), or ‘‘whey (ll% titratable acidity). entitled ‘‘Total Nitrogen—Official (2) For concentrated whey: ‘‘Con- Final Action’’ under the heading centrated (sweet or acid) whey, % ll ‘‘Total Solids,’’ or in section 16.193 (dry solids’’ or ‘‘Concentrated whey (ll% sample), entitled ‘‘Kjeldahl Method’’ titratable acidity), ll% solids’’. under the heading ‘‘Protein—Official (3) For dry (dried) whey: ‘‘Dry (dried) Final Action.’’ (sweet or acid) whey’’ or ‘‘dry (dried) whey, (ll% titratable acidity)’’. (ii) Fat content, 1 to 4 percent—as de- (e) Whey, concentrated whey, or dry termined by the methods prescribed in (dried) whey in a finished food product section 16.059 (liquid sample), ‘‘Reese- shall be listed as ‘‘whey.’’ Gottlieb Method [Reference Method] (11)—Official Final Action’’ under the [46 FR 44439, Sept. 4, 1981; 47 FR 7410, Feb. 19, heading ‘‘Fat,’’ or in section 16.199 (dry 1982, as amended at 54 FR 24899, June 12, 1989; sample), entitled ‘‘Fat in Dried Milk 64 FR 1760, Jan. 12, 1999] (45)—Official Final Action.’’ § 184.1979a Reduced lactose whey. (iii) Ash content, 11 to 27 percent—as determined by the methods prescribed (a) Reduced lactose whey is the substance obtained by the removal of lac- in section 16.035 (liquid sample), enti- tose from whey. The lactose content of tled ‘‘Ash (5)—Official Final Action’’ the finished dry product shall not ex- under the heading ‘‘Total Solids,’’ or in ceed 60 percent. Removal of the lactose section 16.196 (dry sample), entitled is accomplished by physical separation ‘‘Ash—Official Final Action’’ under the techniques such as precipitation, filtra- heading ‘‘Dried Milk, Nonfat Dry Milk, tion, or dialysis. As with whey, reduced and Malted Milk.’’ lactose whey can be used as a fluid, (iv) Lactose content, not more than concentrate, or a dry product form. 60 percent—as determined by the meth- The acidity of reduced lactose whey ods prescribed in section 16.057 (liquid may be adjusted by the addition of safe sample), entitled ‘‘Gravimetric Meth- and suitable pH-adjusting ingredients. od—Official Final Action’’ under the (b) The reduced lactose whey meets heading ‘‘Lactose,’’ or in section 31.061 the following specifications: (dry sample), entitled ‘‘Lane-Eynon (1) The analysis of reduced lactose General Volumetric Method’’ under the whey, on a dry product basis, based on heading ‘‘Lactose—Chemical Meth- analytical methods in the referenced ods—Official Final Action.’’ sections of ‘‘Official Methods of Anal- (v) Moisture content, 1 to 6 percent— ysis of the Association of Official Ana- as determined by the method pre- lytical Chemists,’’ 13th ed. (1980), which scribed in section 16.192, entitled is incorporated by reference in accord- ‘‘Moisture (41)—Official Final Action’’ ance with 5 U.S.C. 552(a) and 1 CFR under the heading ‘‘Dried Milk, Nonfat part 51, is given in paragraphs (b)(1)(i) Dry Milk, and Malted Milk.’’ through (b)(1)(vii) of this section. Cop- (vi) Solids content, variable—as de- ies may be obtained from the AOAC termined by the methods prescribed in

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section 16.032, entitled ‘‘Method I—Offi- (e) The presence of reduced lactose cial Final Action’’ under the heading whey in a finished food product shall be ‘‘Total Solids.’’ listed as ‘‘reduced lactose whey.’’ (vii) Titratable Acidity, variable—as [46 FR 44440, Sept. 4, 1981, as amended at 54 determined by the methods prescribed FR 24899, June 12, 1989; 64 FR 1760, Jan. 12, in section 16.023, entitled ‘‘Acidity (2)— 1999] Official Final Action’’ under the heading ‘‘Milk,’’ or by an equivalent poten- § 184.1979b Reduced minerals whey. tiometric method. (a) Reduced minerals whey is the sub- (2) Limits of impurities are: Heavy stance obtained by the removal of a metals (as lead). Not more than 10 portion of the minerals from whey. The parts per million (0.001 percent), as de- dry product shall not contain more termined by the method described in than 7 percent ash. Reduced minerals the ‘‘Food Chemicals Codex,’’ 4th ed. whey is produced by physical separa- (1996), pp. 760–761, which is incorporated tion techniques such as precipitation, by reference in accordance with 5 filtration, or dialysis. As with whey, U.S.C. 552(a) and 1 CFR part 51. Copies reduced minerals whey can be used as a are available from the National Acad- fluid, concentrate, or a dry product emy Press, Box 285, 2101 Constitution form. The acidity of reduced minerals Ave. NW., Washington, DC 20055 (Inter- whey may be adjusted by the addi- net address http://www.nap.edu), or may tional of safe and suitable pH-adjusting be examined at the Center for Food ingredients. Safety and Applied Nutrition’s Li- (b) The reduced minerals whey meets brary, Food and Drug Administration, the following specifications: 5100 Paint Branch Pkwy., College Park, (1) The analysis of reduced minerals MD 20740, or at the National Archives whey, on a dry product basis, based on and Records Administration (NARA). analytical methods in the referenced For information on the availability of sections of ‘‘Official Methods of Anal- this material at NARA, call 202–741– ysis of the Association of Official Ana- lytical Chemists,’’ 13th ed. (1980), which 6030, or go to: http://www.archives.gov/ is incorporated by reference in accord- federallregister/ ance with 5 U.S.C. 552(a) and 1 CFR codeloflfederallregulations/ part 51, is given in paragraphs (b)(1)(i) ibrllocations.html. through (b)(1)(vii) of this section. Cop- (3) The reduced lactose whey shall be ies may be obtained from the AOAC derived from milk that has been pas- INTERNATIONAL, 481 North Frederick teurized, or the reduced lactose whey Ave., suite 500, Gaithersburg, MD 20877, shall be subjected to pasteurization or may be examined at the Center for techniques or its equivalent before use Food Safety and Applied Nutrition’s in food. Library, Food and Drug Administra- (c) Reduced lactose whey may be tion, 5100 Paint Branch Pkwy., College used in food in accordance with good Park, MD 20740, or at the National Ar- manufacturing practice as indicated in chives and Records Administration § 184.1(b)(1). (NARA). For information on the avail- (d) The percent of lactose present on ability of this material at NARA, call a dry product basis, i.e., ‘‘reduced lac- 202–741–6030, or go to: http:// tose whey (ll% lactose),’’ shall be de- www.archives.gov/federallregister/ clared on the label of the package sold codeloflfederallregulations/ to food manufacturers. The percent of ibrllocations.html. lactose may be declared in 5-percent (i) Protein content, 10 to 24 percent— increments, expressed as a multiple of as determined by the methods pre- 5, not greater than the actual percent- scribed in section 16.036 (liquid sample), entitled ‘‘Total Nitrogen—Official age of lactose in the product, or as an Final Action’’ under the heading actual percentage provided that an ‘‘Total Solids,’’ or in section 16.193 (dry analysis of the product on which the sample), entitled ‘‘Kjeldahl Method’’ actual percentage is based is supplied under the heading ‘‘Protein—Official to the food manufacturer. Final Action.’’

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(ii) Fat content, 1 to 4 percent—as de- 5100 Paint Branch Pkwy., College Park, termined by the methods prescribed in MD 20740, or at the National Archives section 16.059 (liquid sample), ‘‘Reese- and Records Administration (NARA). Gottlieb Method [Reference Method] For information on the availability of (11)—Official Final Action’’ under the this material at NARA, call 202–741– heading ‘‘Fat,’’ or in section 16.199 (dry 6030, or go to: http://www.archives.gov/ sample), entitled ‘‘Fat in Dried Milk federallregister/ (45)—Official Final Action.’’ codeloflfederallregulations/ (iii) Ash content, maximum 7 per- ibrllocations.html. cent—as determined by the methods (3) The reduced minerals whey shall prescribed in section 16.035 (liquid sam- be derived from milk that has been pas- ple), entitled ‘‘Ash (5)—Official Final teurized, or the reduced minerals whey Action’’ under the heading ‘‘Total Sol- shall be subjected to pasteurization ids,’’ or in section 16.196 (dry sample), techniques or its equivalent before use entitled ‘‘Ash—Official Final Action’’ in food. under the heading ‘‘Dried Milk, Nonfat (c) The reduced minerals whey may Dry Milk, and Malted Milk.’’ be used in food in accordance with good (iv) Lactose content, maximum 85 manufacturing practice as indicated in percent—as determined by the methods § 184.1(b)(1). prescribed in section 16.057 (liquid sam- (d) The percent of minerals present ple), entitled ‘‘Gravimetric Method— on a dry product basis, i.e., ‘‘reduced Official Final Action’’ under the head- minerals whey (ll% minerals),’’ shall ing ‘‘Lactose,’’ or in section 31.061 (dry be declared on the label of the package sample), entitled ‘‘Lane-Eynon General sold to food manufacturers. The per- Volumetric Method’’ under the heading cent of minerals may be declared in 2- ‘‘Lactose—Chemical Methods—Official percent increments expressed as a mul- Final Action.’’ tiple of 2, not greater than the actual (v) Moisture content, 1 to 6 percent— percentage of minerals in the product, as determined by the methods pre- or as an actual percentage provided scribed in section 16.192, entitled that an analysis of the product on ‘‘Moisture (41)—Official Final Action’’ which the actual percentage is based is under the heading ‘‘Dried Milk, Nonfat supplied to the food manufacturer. Dry Milk, and Malted Milk.’’ (e) The presence of reduced minerals (vi) Solids content, variable—as de- whey in a finished food product shall be termined by the methods prescribed in listed as ‘‘reduced minerals whey’’. section 16.032, entitled ‘‘Method I—Offi- cial Final Action’’ under the heading [46 FR 44441, Sept. 4, 1981, as amended at 54 ‘‘Total Solid.’’ FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, (vii) Titratable Acidity, variable—as 1999] determined by the methods prescribed § 184.1979c Whey protein concentrate. in section 16.023, entitled ‘‘Acidity (2)— Official Final Action’’ under the head- (a) Whey protein concentrate is the ing ‘‘Milk,’’ or by an equivalent poten- substance obtained by the removal of tiometric method. sufficient nonprotein constituents from (2) Limits of impurities are: Heavy whey so that the finished dry product metals (as lead). Not more than 10 contains not less than 25 percent pro- parts per million (0.001 percent), as de- tein. Whey protein concentrate is pro- termined by the method described in duced by physical separation tech- the ‘‘Food Chemicals Codex,’’ 4th ed. niques such as precipitation, filtration, (1996), pp. 760–761, which is incorporated or dialysis. As with whey, whey protein by reference in accordance with 5 concentrate can be used as a fluid, con- U.S.C. 552(a) and 1 CFR part 51. Copies centrate, or dry product form. The are available from the National Acad- acidity of whey protein concentrate emy Press, Box 285, 2101 Constitution may be adjusted by the addition of safe Ave. NW., Washington, DC 20055 (Inter- and suitable pH-adjusting ingredients. net address http://www.nap.edu), or may (b) The whey protein concentrate be examined at the Center for Food meets the following specifications: Safety and Applied Nutrition’s Li- (1) The analysis of whey protein con- brary, Food and Drug Administration, centrate, on a dry product basis, based

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on analytical methods in the ref- ‘‘Lactose—Chemical Methods—Official erenced sections of ‘‘Official Methods Final Action.’’ of Analysis of the Association of Offi- (v) Moisture content, 1 to 6 percent— cial Analytical Chemists,’’ 13th ed. as determined by the methods pre- (1980), which is incorporated by ref- scribed in section 16.192, entitled erence in accordance with 5 U.S.C. ‘‘Moisture (41)—Official Final Action’’ 552(a) and 1 CFR part 51, is given in under the heading ‘‘Dried Milk, Nonfat paragraphs (b)(1)(i) through (b)(1)(vii) Dry Milk, and Malted Milk.’’ of this section. Copies may be obtained (vi) Solids content, variable—as de- from the AOAC INTERNATIONAL, 481 termined by the methods prescribed in North Frederick Ave., suite 500, Gai- section 16.032, entitled ‘‘Method I—Offi- thersburg, MD 20877, or may be exam- cial Final Action’’ under the heading ined at the Center for Food Safety and ‘‘Total Solids.’’ Applied Nutrition’s Library, Food and (vii) Titratable Acidity, variable—as Drug Administration, 5100 Paint determined by the methods prescribed Branch Pkwy., College Park, MD 20740, in section 16.023, entitled ‘‘Acidity (2)— or at the National Archives and Official Final Action’’ under the head- Records Administration (NARA). For ing ‘‘Milk,’’ or by an equivalent poten- information on the availability of this tiometric method. material at NARA, call 202–741–6030, or (2) Limits of impurities are: Heavy go to: http://www.archives.gov/ metals (as lead). Not more than 10 federallregister/ parts per million (0.001 percent), as de- codeloflfederallregulations/ termined by the method described in ibrllocations.html. the ‘‘Food Chemicals Codex,’’ 4th ed. (i) Protein content, minimum 25 per- (1996), pp. 760–761, which is incorporated cent—as determined by the methods by reference in accordance with 5 prescribed in section 16.036 (liquid sam- U.S.C. 552(a) and 1 CFR part 51. Copies ple), entitled ‘‘Total Nitrogen—Offi- are available from the National Acad- cials Final Action’’ under the heading emy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Inter- ‘‘Total Solids,’’ or in section 16.193 (dry net address http://www.nap.edu), or may sample), entitled ‘‘Kjeldahl Method’’ be examined at the Center for Food under the heading ‘‘Protein—Official Safety and Applied Nutrition’s Li- Final Action.’’ brary, Food and Drug Administration, (ii) Fat content, 1 to 10 percent—as 5100 Paint Branch Pkwy., College Park, determined by the methods prescribed MD 20740, or at the National Archives in section 16.059 (liquid sample), and Records Administration (NARA). ‘‘Reese-Gottlieb Method [Reference For information on the availability of Method] (11)—Official Final Action’’ this material at NARA, call 202–741– under the heading ‘‘Fat,’’ or in section 6030, or go to: http://www.archives.gov/ 16.199 (dry sample), entitled ‘‘Fat in federallregister/ Dried Milk (45)—Official Final Action.’’ codeloflfederallregulations/ (iii) Ash content, 2 to 15 percent—as ibrllocations.html. determined by the methods prescribed (3) The whey protein concentrate in section 16.035 (liquid sample), enti- shall be derived from milk that has tled ‘‘Ash (5)—Official Final Action’’ been pasteurized, or the whey protein under the heading ‘‘Total Solids,’’ or in concentrate shall be subjected to pas- section 16.196 (dry sample), entitled teurization techniques or its equiva- ‘‘Ash—Official Final Action’’ under the lent before use in food. heading ‘‘Dried Milk, Nonfat Dry Milk, (c) The whey protein concentrate and Malted Milk.’’ may be used in food in accordance with (iv) Lactose content, maximum 60 good manufacturing practice as indi- percent—as determined by the methods cated in § 184.1(b)(1). prescribed in section 16.057 (liquid sam- (d) The percent of protein present on ple), entitled ‘‘Gravimetric Method— a dry product basis, i.e., ‘‘whey protein Official Final Action’’ under the head- concentrate (ll% protein),’’ shall be ing ‘‘Lactose,’’ or in section 31.061 (dry declared on the label of the package sample), entitled ‘‘Lane-Eynon General sold to food manufacturers. The per- Volumetric Method’’ under the heading cent of protein may be declared in 5-

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percent increments, expressed as a cooled, which causes the zein to pre- multiple of 5, not greater than the ac- cipitate. tual percentage of protein in the prod- (b) The ingredient must be of a pu- uct, or as an actual percentage pro- rity suitable for its intended use. vided that an analysis of the product (c) In accordance with § 184.1(b)(1), on which the actual percentage is the ingredient is used in food with no based is supplied to the food manufac- limitation other than current good turer. manufacturing practice. The affirma- (e) The presence of whey protein con- tion of this ingredient as generally rec- centrate in a finished food product ognized as safe (GRAS) as a direct shall be listed as ‘‘whey protein con- human food ingredient is based upon centrate’’. the following current good manufac- [46 FR 44441, Sept. 4, 1981, as amended at 54 turing practice conditions of use: FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, (1) The ingredient is used as a sur- 1999] face-finishing agent as defined in § 170.3(o)(30) of this chapter. § 184.1983 Bakers yeast extract. (2) The ingredient is used in food at (a) Bakers yeast extract is the food levels not to exceed current good man- ingredient resulting from concentra- ufacturing practice. tion of the solubles of mechanically (d) Prior sanctions for this ingredient ruptured cells of a selected strain of different from the uses established in yeast, Saccharomyces cerevisiae. It may this section do not exist or have been be concentrated or dried. waived. (b) The ingredient meets the fol- [50 FR 8999, Mar. 6, 1985, as amended at 73 FR lowing specifications on a dry weight 8608, Feb. 14, 2008] basis: Less than 0.4 part per million (ppm) arsenic, 0.13 ppm cadmium, 0.2 § 184.1985 Aminopeptidase enzyme ppm lead, 0.05 ppm mercury, 0.09 ppm preparation derived from selenium, and 10 ppm zinc. lactococcus lactis. (c) The viable microbial content of (a) Aminopeptidase enzyme prepara- the finished ingredient as a con- tion is derived from the nonpathogenic centrate or dry material is: and nontoxicogenic bacterium (1) Less than 10,000 organisms/gram Lactococcus lactis (previously named by aerobic plate count. Streptococcus lactis). The preparation (2) Less than 10 yeasts and molds/ contains the enzyme aminopeptidase gram. (CAS Reg. No. 9031–94–1; EC 3.4.11.1) and (3) Negative for Salmonella, E. coli, other peptidases that hydrolyze milk coagulase positive Staphylococci, Clos- proteins. The preparation is produced tridium perfringens, Clostridium botu- by pure culture fermentation. linum, or any other recognized micro- (b) The ingredient meets the speci- bial pathogen or any harmful microbial fications for enzyme preparations in toxin. the Food Chemicals Codex, 3d ed. (1981), (d) The ingredient is used as a fla- pp. 107–110, which are incorporated by voring agent and adjuvant as defined in reference in accordance with 5 U.S.C. § 170.3(o)(12) of this chapter at a level 552(a) and 1 CFR part 51. Copies are not to exceed 5 percent in food. available from the National Academy (e) This regulation is issued prior to Press, 2101 Constitution Ave. NW., general evaluation of use of this ingre- Washington, DC 20418, or may be exam- dient in order to affirm as GRAS the ined at the Division of Petition Control specific use named. (HFS–215), Center for Food Safety and Applied Nutrition, Food and Drug Ad- § 184.1984 Zein. ministration, 1110 Vermont Ave. NW., (a) Zein (CAS Reg. No. 9010–66–6) is suite 1200, Washington, DC, or at the one of the components of corn gluten. National Archives and Records Admin- It is produced commercially by extrac- istration (NARA). For information on tion from corn gluten with alkaline the availability of this material at aqueous isopropyl alcohol containing NARA, call 202–741–6030, or go to: http:// sodium hydroxide. The extract is then www.archives.gov/federallregister/

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codeloflfederallregulations/ Subpart A—General Provisions ibrllocations.html. (c) In accordance with § 184.1(b)(1), § 186.1 Substances added indirectly to the ingredient is used in food with no human food affirmed as generally limitations other than current good recognized as safe (GRAS). manufacturing practice. The affirma- (a) The indirect human food ingredi- tion of this ingredient as generally rec- ents listed in this part have been re- ognized as safe as a direct human food viewed by the Food and Drug Adminis- ingredient is based upon the following tration and determined to be generally current good manufacturing practice recognized as safe (GRAS) for the pur- conditions of use: poses and under the conditions prescribed, providing they comply with (1) The ingredient is used as an en- the purity specifications listed in this zyme, as defined in § 170.3(o)(9) of this part or, in the absence of purity speci- chapter, as an optional ingredient for fications, are of a purity suitable for flavor development in the manufacture their intended use in accordance with of cheddar cheese, in accordance with § 170.30(h)(1) of this chapter. Certain in- § 133.113 of this chapter, and in the gredients in this part may also be used preparation of protein hydrolysates. in food-contact surfaces in accordance (2) The ingredient is used at levels with parts 174, 175, 176, 177, 178 or not to exceed current good manufac- § 179.45 of this chapter. Ingredients af- turing practice. firmed as GRAS for direct use in part 184 of this chapter are also GRAS as in- [60 FR 54193, Oct. 20, 1995] direct human food ingredients in accordance with § 184.1(a) of this chapter. PART 186—INDIRECT FOOD SUB- (b) The regulations in this part do STANCES AFFIRMED AS GEN- not authorize direct addition of any ERALLY RECOGNIZED AS SAFE food ingredient to a food. They authorize only the use of these ingredients as Subpart A—General Provisions indirect ingredients of food, through migration from their immediate wrap- Sec. per, container, or other food-contact 186.1 Substances added indirectly to human surface. Any ingredient affirmed as food affirmed as generally recognized as GRAS in this part shall be used in ac- safe (GRAS). cordance with current good manufacturing practice. For the purpose of this Subpart B—Listing of Specific Substances part, current good manufacturing prac- Affirmed as GRAS tice includes the requirements that an 186.1093 Sulfamic acid. indirect human food ingredient be of a 186.1256 Clay (kaolin). purity suitable for its intended use, 186.1275 Dextrans. and that it be used at a level no higher 186.1300 Ferric oxide. than reasonably required to achieve its 186.1316 Formic acid. intended technical effect in the food- 186.1374 Iron oxides. contact article. 186.1551 Hydrogenated fish oil. (1) If the ingredient is affirmed as 186.1555 Japan wax. GRAS with no limitations on its condi- 186.1557 Tall oil. tions of use other than current good 186.1673 Pulp. manufacturing practice, it shall be re- 186.1750 Sodium chlorite. garded as GRAS if its conditions of use 186.1756 Sodium formate. are consistent with the requirements of 186.1770 Sodium oleate. paragraphs (b), (c), and (d) of this sec- 186.1771 Sodium palmitate. tion. When the Food and Drug Admin- 186.1797 Sodium sulfate. istration (FDA) determines that it is 186.1839 Sorbose. appropriate, the agency will describe one or more current good manufac- AUTHORITY: 21 U.S.C. 321, 342, 348, 371. turing practice conditions of use in the SOURCE: 42 FR 14658, Mar. 15, 1977, unless regulation that affirms the GRAS sta- otherwise noted. tus of the indirect ingredient. For example, when the safety of an ingredient

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