and Drug Administration, HHS Pt. 184

§ 182.8217 Calcium phosphate. § 182.8988 . (a) Product. Calcium phosphate (a) Product. Zinc gluconate. (mono-, di-, and tribasic). (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.8991 Zinc oxide. § 182.8223 Calcium pyrophosphate. (a) Product. Zinc oxide. (a) Product. Calcium pyrophosphate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.8994 Zinc stearate. § 182.8250 . (a) Product. Zinc stearate prepared (a) Product. Choline bitartrate. from stearic free from chickedema (b) Conditions of use. This substance factor. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.8252 Choline chloride. § 182.8997 Zinc sulfate. (a) Product. Choline chloride. (b) Conditions of use. This substance (a) Product. Zinc sulfate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.8778 phosphate. (a) Product. Sodium phosphate PART 184—DIRECT FOOD SUB- (mono-, di-, and tribasic). STANCES AFFIRMED AS GEN- (b) Conditions of use. This substance ERALLY RECOGNIZED AS SAFE is generally recognized as safe when used in accordance with good manufac- Subpart A—General Provisions turing practice. Sec. 184.1 Substances added directly to human § 182.8890 Tocopherols. food affirmed as generally recognized as (a) Product. Tocopherols. safe (GRAS). (b) Conditions of use. This substance is generally recognized as safe when Subpart B—Listing of Specific Substances used in accordance with good manufac- Affirmed as GRAS turing practice. 184.1005 . 184.1007 Aconitic acid. § 182.8892 α-Tocopherol acetate. 184.1009 Adipic acid. (a) Product. a-Tocopherol acetate. 184.1011 Alginic acid. 184.1012 a-Amylase enzyme preparation (b) Conditions of use. This substance from Bacillus stearothermophilus. is generally recognized as safe when 184.1021 Benzoic acid. used in accordance with good manufac- 184.1024 Bromelain. turing practice. 184.1025 Caprylic acid. 184.1027 Mixed carbohydrase and protease § 182.8985 Zinc chloride. enzyme product. (a) Product. Zinc chloride. 184.1033 Citric acid. 184.1034 Catalase (bovine liver). (b) Conditions of use. This substance 184.1061 . is generally recognized as safe when 184.1063 Enzyme-modified lecithin. used in accordance with good manufac- 184.1065 Linoleic acid. turing practice. 184.1069 Malic acid.

485

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00495 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Pt. 184 21 CFR Ch. I (4–1–15 Edition)

184.1077 acid . 184.1307 Ferric sulfate. 184.1081 Propionic acid. 184.1307a Ferrous ascorbate. 184.1090 Stearic acid. 184.1307b Ferrous carbonate. 184.1091 Succinic acid. 184.1307c Ferrous citrate. 184.1095 Sulfuric acid. 184.1307d Ferrous fumarate. 184.1097 Tannic acid. 184.1308 Ferrous gluconate. 184.1099 . 184.1311 Ferrous lactate. 184.1101 Diacetyl tartaric acid esters of 184.1315 Ferrous sulfate. mono- and diglycerides. 184.1316 Ficin. 184.1115 Agar-agar. 184.1317 Garlic and its derivatives. 184.1120 Brown algae. 184.1318 Glucono delta-lactone. 184.1121 Red algae. 184.1321 Corn gluten. 184.1133 alginate. 184.1322 Wheat gluten. 184.1135 Ammonium bicarbonate. 184.1323 Glyceryl monooleate. 184.1137 Ammonium carbonate. 184.1324 Glyceryl monostearate. 184.1138 Ammonium chloride. 184.1328 Glyceryl behenate. 184.1139 Ammonium hydroxide. 184.1329 Glyceryl palmitostearate. 184.1140 Ammonium citrate, dibasic. 184.1330 Acacia (gum arabic). 184.1141a Ammonium phosphate, monobasic. 184.1333 Gum ghatti. 184.1141b Ammonium phosphate, dibasic. 184.1339 Guar gum. 184.1143 Ammonium sulfate. 184.1343 Locust (carob) bean gum. 184.1148 Bacterially-derived carbohydrase 184.1349 Karaya gum (sterculia gum). enzyme preparation. 184.1351 Gum tragacanth. 184.1150 Bacterially-derived protease en- 184.1355 Helium. zyme preparation. 184.1366 Hydrogen peroxide. 184.1155 Bentonite. 184.1370 Inositol. 184.1157 Benzoyl peroxide. 184.1372 Insoluble isomerase enzyme 184.1165 n-Butane and iso-butane. preparations. 184.1185 Calcium acetate. 184.1375 Iron, elemental. 184.1187 Calcium alginate. 184.1386 Isopropyl citrate. 184.1191 Calcium carbonate. 184.1387 Lactase enzyme preparation from 184.1193 . Candida pseudotropicalis. 184.1195 Calcium citrate. 184.1388 Lactase enzyme preparation from 184.1199 . Kluyveromyces lactis. 184.1201 Calcium glycerophosphate. 184.1400 Lecithin. 184.1205 Calcium hydroxide. 184.1408 Licorice and licorice derivatives. 184.1206 Calcium iodate. 184.1409 Ground limestone. 184.1207 . 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 . 184.1230 Calcium sulfate. 184.1428 Magnesium hydroxide. 184.1240 . 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 (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 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.

486

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00496 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1

184.1555 Rapeseed oil. 184.1945 Vitamin B12. 184.1560 Ox bile extract. 184.1950 Vitamin D. 184.1563 Ozone. 184.1973 Beeswax (yellow and white). 184.1583 Pancreatin. 184.1976 Candelilla wax. 184.1585 Papain. 184.1978 Carnauba wax. 184.1588 Pectins. 184.1979 Whey. 184.1595 Pepsin. 184.1979a Reduced lactose whey. 184.1610 Potassium alginate. 184.1979b Reduced minerals whey. 184.1613 Potassium bicarbonate. 184.1619 . 184.1979c Whey protein concentrate. 184.1622 . 184.1983 Bakers yeast extract. 184.1625 . 184.1984 Zein. 184.1631 . 184.1985 Aminopeptidase enzyme prepara- 184.1634 . tion derived from lactococcus lactis. 184.1635 Potassium iodate. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. 184.1639 Potassium lactate. 184.1643 Potassium sulfate. SOURCE: 42 FR 14653, Mar 15, 1977, unless 184.1655 Propane. otherwise noted. 184.1660 Propyl gallate. EDITORIAL NOTE: Nomenclature changes to 184.1666 Propylene glycol. part 184 appear at 66 FR 56035, Nov. 6, 2001, 66 184.1670 Propylparaben. FR 66742, Dec. 27, 2001, 68 FR 15355, Mar. 31, 184.1676 Pyridoxine hydrochloride. 184.1685 Rennet (animal-derived) and 2003, 69 FR 13717, Mar. 24, 2004, 70 FR 40880, chymosin preparation (fermentation-de- July 15, 2005, and 70 FR 67651, Nov. 8, 2005. rived). 184.1695 Riboflavin. Subpart A—General Provisions 184.1697 Riboflavin-5′-phosphate (sodium). 184.1698 Rue. § 184.1 Substances added directly to 184.1699 Oil of rue. human food affirmed as generally 184.1702 Sheanut oil. recognized as safe (GRAS). 184.1721 . 184.1724 Sodium alginate. (a) The direct human food ingredi- 184.1733 Sodium benzoate. ents listed in this part have been re- 184.1736 . viewed by the Food and Drug Adminis- 184.1742 Sodium carbonate. tration and determined to be generally 184.1751 Sodium citrate. recognized as safe (GRAS) for the pur- 184.1754 Sodium diacetate. poses and under the conditions pre- 184.1763 Sodium hydroxide. 184.1764 Sodium hypophosphite. scribed. The regulations in this part 184.1768 . shall sufficiently describe each ingre- 184.1769a Sodium metasilicate. dient to identify the characteristics of 184.1784 Sodium propionate. the ingredient that has been affirmed 184.1792 Sodium sesquicarbonate. as GRAS and to differentiate it from 184.1801 Sodium tartrate. other possible versions of the ingre- 184.1804 Sodium . dient that have not been affirmed as 184.1807 Sodium thiosulfate. 184.1835 . GRAS. Ingredients affirmed as GRAS 184.1845 Stannous chloride (anhydrous and in this part are also GRAS as indirect dihydrated). human food ingredients, subject to any 184.1848 Starter distillate. limitations prescribed in parts 174, 175, 184.1851 Stearyl citrate 176, 177, 178 or § 179.45 of this chapter or 184.1854 . in part 186 of this chapter. The purity 184.1857 Corn sugar. specifications in this part do not apply 184.1859 Invert sugar. 184.1865 Corn syrup. when the ingredient is used in indirect 184.1866 High corn syrup. applications. However, when used in in- 184.1875 Thiamine hydrochloride. direct applications, the ingredient 184.1878 Thiamine mononitrate. must be of a purity suitable for its in- 184.1890 a-Tocopherols. tended use in accordance with 184.1901 Triacetin. § 170.30(h)(1) of this chapter. 184.1903 Tributyrin. (b) Any ingredient affirmed as GRAS 184.1911 Triethyl citrate. in this part shall be used in accordance 184.1914 Trypsin. 184.1923 . with current good manufacturing prac- 184.1924 Urease enzyme preparation from tice. For the purpose of this part, cur- Lactobacillus fermentum. rent good manufacturing practice in- 184.1930 Vitamin A. cludes the requirements that a direct

487

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00497 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1 21 CFR Ch. I (4–1–15 Edition)

human food ingredient be of appro- eral evaluation of use of the ingredient, priate food grade; that it be prepared other uses may also be GRAS. and handled as a food ingredient; and (c) The listing of a food ingredient in that the quantity of the ingredient this part does not authorize the use of added to food does not exceed the such substance in a manner that may amount reasonably required to accom- lead to deception of the consumer or to plish the intended physical, nutri- any other violation of the Federal tional, or other technical effect in Food, Drug, and Cosmetic Act (the food. Act). (1) If the ingredient is affirmed as (d) The listing of more than one in- GRAS with no limitations on its condi- gredient to produce the same techno- tions of use other than current good logical effect does not authorize use of manufacturing practice, it shall be re- a combination of two or more ingredi- garded as GRAS if its conditions of use ents to accomplish the same techno- are consistent with the requirements of logical effect in any one food at a com- paragraph (b), (c), and (d) of this sec- bined level greater than the highest tion. When the Food and Drug Admin- level permitted for one of the ingredi- istration (FDA) determines that it is ents. appropriate, the agency will describe (e) If the Commissioner of Food and one or more current good manufac- Drugs is aware of any prior sanction turing practice conditions of use in the for use of an ingredient under condi- regulation that affirms the GRAS sta- tions different from those proposed to tus of the ingredient. For example, be affirmed as GRAS, he will concur- when the safety of an ingredient has rently propose a separate regulation been evaluated on the basis of limited covering such use of the ingredient conditions of use, the agency will de- under part 181 of this chapter. If the scribe in the regulation that affirms Commissioner is unaware of any such the GRAS status of the ingredient, one applicable prior sanction, the proposed or more of these limited conditions of regulation will so state and will re- use, which may include the category of food(s), the technical effect(s) or func- quire any person who intends to assert tional use(s) of the ingredient, and the or rely on such sanction to submit level(s) of use. If the ingredient is used proof of its existence. Any regulation under conditions that are significantly promulgated pursuant to this section different from those described in the constitutes a determination that ex- regulation, that use of the ingredient cluded uses would result in adultera- may not be GRAS. In such a case, a tion of the food in violation of section manufacturer may not rely on the reg- 402 of the Act, and the failure of any ulation as authorizing that use but person to come forward with proof of shall independently establish that that such an applicable prior sanction in re- use is GRAS or shall use the ingredient sponse to the proposal will constitute a in accordance with a food additive reg- waiver of the right to assert or rely on ulation. Persons seeking FDA approval such sanction at any later time. The of an independent determination that a notice will also constitute a proposal use of an ingredient is GRAS may sub- to establish a regulation under part 181 mit a GRAS petition in accordance of this chapter, incorporating the same with § 170.35 of this chapter. provisions, in the event that such a (2) If the ingredient is affirmed as regulation is determined to be appro- GRAS with specific limitation(s), it priate as a result of submission of proof shall be used in food only within such of such an applicable prior sanction in limitation(s), including the category of response to the proposal. food(s), the functional use(s) of the in- (f) The label and labeling of the in- gredient, and the level(s) of use. Any gredient and any intermediate mix of use of such an ingredient not in full the ingredient for use in finished food compliance with each such established shall bear, in addition to the other la- limitation shall require a food additive beling required by the Act: regulation. (1) The name of the ingredient, ex- (3) If the ingredient is affirmed as cept where exempted from such label- GRAS for a specific use, without a gen- ing in part 101 of this chapter.

488

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00498 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1007

(2) A statement of concentration of ufacturing practice in accordance with the ingredient in any intermediate § 184.1(b)(1). Current good manufac- mix; or other information to permit a turing practice results in a maximum food processor independently to deter- level as served, of 0.25 percent for mine that use of the ingredients will be baked goods as defined in § 170.3(n)(1) of in accordance with any limitations and this chapter; 0.8 percent for cheeses as good manufacturing practice gudelines defined in § 170.3(n)(5) of this chapter prescribed. and dairy product analogs as defined in (3) Adequate directions for use to § 170.3(n)(10) of this chapter; 0.5 percent provide a final food product that com- for chewing gum as defined in plies with any limitations prescribed § 170.3(n)(6) of this chapter; 9.0 percent for the ingredient(s). for condiments and relishes as defined in § 170.3(n)(8) of this chapter; 0.5 per- [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 48 FR 48457, 48459, Oct. cent for fats and oils as defined in 19, 1983; 62 FR 15110, Mar. 31, 1997] § 170.3(n)(12) of this chapter; 3.0 percent for gravies and sauces as defined in Subpart B—Listing of Specific § 170.3(n)(24) of this chapter; 0.6 percent for meat products as defined in Substances Affirmed as GRAS § 170.3(n)(29) of this chapter; and 0.15 § 184.1005 Acetic acid. percent or less for all other food cat- egories. The ingredient may also be (a) Acetic acid (C2H4O2, CAS Reg. No. used in boiler water additives at levels 64–19–7) is known as ethanoic acid. It not to exceed current good manufac- occurs naturally in plant and animal turing practice. tissues. It is produced by fermentation (e) Prior sanctions for this ingredient of carbohydrates or by organic syn- different from the uses established in thesis. The principal synthetic meth- this section do not exist or have been ods currently employed are oxidation waived. of acetaldehyde derived from ethylene, liquid phase oxidation of butane, and [47 FR 27814, June 25, 1982] reaction of carbon monoxide with methanol derived from natural gas. § 184.1007 Aconitic acid. (b) The ingredient meets the speci- (a) Aconitic acid (1,2,3- fications of the Food Chemicals Codex, propenetricarboxylic acid (C6H6O6), 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 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

489

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00499 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1009 21 CFR Ch. I (4–1–15 Edition)

Library, Food and Drug Administra- this section do not exist or have been tion, 5100 Paint Branch Pkwy., College waived. Park, MD 20740, or at the National Ar- [43 FR 47724, Oct. 17, 1978, as amended at 49 chives and Records Administration FR 5610, Feb. 14, 1984; 64 FR 1759, Jan. 12, (NARA). For information on the avail- 1999] ability of this material at NARA, call 202–741–6030, or go to: http:// § 184.1009 Adipic acid. www.archives.gov/federallregister/ (a) Adipic acid (C6H10O4, CAS Reg. codeloflfederallregulations/ No. 00124–04–9) is also known as 1,4- ibrllocations.html. butanedicarboxylic acid or hexane- (2) Melting point. Not less than 195 °C dioic acid. It is prepared by nitric acid and the determination results in de- oxidation of cyclohexanol or composition of aconitic acid. cyclohexanone or a mixture of the two. (b) The ingredient meets the speci- (3) Heavy metals (as Pb). Not more fications of the Food Chemicals Codex, than 10 parts per million. 3d Ed. (1981), p. 11, which is incor- (4) Arsenic (as As). Not more than 3 porated by reference (Copies are avail- parts per million. able from the National Academy Press, (5) Oxalate. Passes test. 2101 Constitution Ave., NW., Wash- (6) Readily carbonizable substances. ington, DC 20418, or available for in- Passes the test for citric acid of the spection at the National Archives and ‘‘Food Chemicals Codex,’’ 4th ed. (1996), Records Administration (NARA). For pp. 102–103, which is incorporated by information on the availability of this reference in accordance with 5 U.S.C. material at NARA, call 202–741–6030, or 552(a) and 1 CFR part 51. The avail- go to: http://www.archives.gov/ ability of this incorporation by ref- federallregister/ erence is given in paragraph (b)(1) of codeloflfederallregulations/ this section. ibrllocations.html.), and the following (7) Residue on ignition. Not more than additional specifications: 0.1 percent as determined by the ‘‘Food (1) The adipic acid is converted to its corresponding amide. The amide is pu- Chemicals Codex,’’ 4th ed. (1996), pp. rified by recrystallization from water 102–103, test for citric acid, which is in- or aqueous . The melting range corporated by reference in accordance of the amide is 219° to 220 °C. with 5 U.S.C. 552(a) and 1 CFR part 51. (2) The adipic acid is converted to its The availability of this incorporation corresponding bis-p-p-bromophenacyl by reference is given in paragraph ester. The ester is purified by recrys- (b)(1) of this section. tallization from ethanol. The melting (c) The ingredient is used as a fla- range of the ester is 153° to 154 °C. voring substance and adjuvant as de- (c) The ingredient is used as a fla- fined in § 170.3(o)(12) of this chapter. voring agent as defined in § 170.3(o)(12) (d) The ingredient is used in food, in of this chapter; leavening agent as de- accordance with § 184.1(b)(1), at levels fined in § 170.3(o)(17) of this chapter; not to exceed good manufacturing and pH control agent as defined in practice. Current good manufacturing § 170.3(o)(23) of this chapter. practice results in a maximum level, as (d) The ingredient is used in at served, of 0.003 percent for baked goods levels not to exceed current good man- as defined in § 170.3(n)(1) of this chap- ufacturing practice in accordance with ter, 0.002 percent for alcoholic bev- § 184.1(b)(1). Current good manufac- erages as defined in § 170.3(n)(2) of this turing practice results in maximum 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

490

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00500 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1012

percent for fats and oil as defined in this section do not exist or have been § 170.3(n)(12) of this chapter; 0.0004 per- waived. cent for frozen dairy desserts as defined in § 170.3(n)(20) of this chapter; 0.55 per- [47 FR 47375, Oct. 26, 1982] cent for gelatin and puddings as de- § 184.1012 α-Amylase enzyme prepara- fined in § 170.3(n)(22) of this chapter; 0.1 tion from Bacillus percent for gravies as defined in stearothermophilus. § 170.3(n)(24) of this chapter; 0.3 percent for meat products as defined in (a) a-Amylase enzyme preparation is § 170.3(n)(29) of this chapter; 1.3 percent obtained from the culture filtrate that for snack foods as defined in results from a pure culture fermenta- § 170.3(n)(37) of this chapter; and 0.02 tion of a nonpathogenic and percent or less for all other food cat- nontoxicogenic strain of Bacillus egories. stearothermophilus. Its characterizing (e) Prior sanctions for adipic acid dif- enzyme activity is a-amylase (1,4 a-D ferent from the uses established in this glucan glucanohydrolase (E.C. 3.2.1.1)). section do not exist or have been (b) The ingredient meets the general waived. and additional requirements for en- [47 FR 27810, June 25, 1982] zyme preparations in the ‘‘Food Chemi- cals Codex,’’ 3d ed. (1981), pp. 107–110, § 184.1011 Alginic acid. which is incorporated by reference in (a) Alginic acid is a colloidal, hydro- accordance with 5 U.S.C. 552(a) and 1 philic polysaccharide obtained from CFR part 51. Copies are available from certain brown algae by alkaline extrac- the National Academy Press, 2101 Con- tion. stitution Ave. NW., Washington, DC (b) The ingredient meets the speci- 20418, or may be examined at the Office fications of the Food Chemicals Codex, Food Additive Safety (HFS–200), Center 3d Ed. (1981), p. 13, which is incor- for Food Safety and Applied Nutrition, porated by reference. Copies are avail- Food and Drug Administration, 5100 able from the National Academy Press, Paint Branch Pkwy., College Park, MD 2101 Constitution Ave. NW., Wash- 20740, 240–402–1200, or at the National ington, DC 20418, or available for in- Archives and Records Administration spection at the National Archives and (NARA). For information on the avail- Records Administration (NARA). For ability of this material at NARA, call information on the availability of this 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/ federal register/ l ibrllocations.html. codeloflfederallregulations/ (c) In accordance with § 184.1(b)(1), ibrllocations.html. (c) In accordance with § 184.1(b)(2), the ingredient is used in food with no the ingredient is used in food only limitation other than current good within the following specific limita- manufacturing practices. The affirma- tions: tion of this ingredient as GRAS as a di- rect human food ingredient is based Maximum level of upon the following current good manu- Category of food use in food (as Functional use served) facturing practice conditions of use: (1) The ingredient is used as an en- Soup and soup Not to exceed cur- Emulsifier, emulsi- mixes, rent good manu- fier salt, zyme, as defined in § 170.3(o)(9) of this § 170.3(n) (40) facturing prac- § 170.3(o)(8) of chapter, in the of edible of this chapter. tice. this chapter; for- starch to produce maltodextrins and mulation aid, § 170.3(o)(14) of nutritive carbohydrate sweeteners. this chapter; sta- (2) The ingredient is used at levels bilizer, thickener, not to exceed current good manufac- § 170.3(o)(28) of this chapter. turing practices. [60 FR 55789, Nov. 3, 1995, as amended at 78 (d) Prior sanctions for this ingredient FR 14666, Mar. 7, 2013] different from the use established in

491

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00501 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1021 21 CFR Ch. I (4–1–15 Edition)

§ 184.1021 Benzoic acid. acterizing enzyme activity is that of a peptide hydrolase (EC 3.4.22.32). (a) Benzoic acid is the chemical (b) The ingredient meets the general benzenecarboxylic acid (C H O ), occur- 7 6 2 requirements and additional require- ring in nature in free and combined ments for enzyme preparations in the forms. Among the foods in which ben- Food Chemicals Codex, 3d ed. (1981), p. zoic acid occurs naturally are cran- 110, which is incorporated by reference berries, prunes, plums, cinnamon, ripe in accordance with 5 U.S.C. 552(a) and 1 cloves, and most berries. Benzoic acid CFR part 51. Copies are available from is manufactured by treating molten the National Academy Press, 2101 Con- phthalic anhydride with steam in the stitution Ave. NW., Washington, DC, or presence of a zinc oxide catalyst, by may be examined at Office of Food Ad- the hydrolysis of benzotrichloride, or ditive Safety (HFS–200), Center for by the oxidation of toluene with nitric Food Safety and Applied Nutrition, acid or sodium bichromate or with air Food and Drug Administration, 5100 in the presence of a transition metal Paint Branch Pkwy., College Park, MD salt catalyst. 20740, 240–402–1200, and at the National (b) The ingredient meets the speci- Archives and Records Administration fications of the ‘‘Food Chemicals (NARA). For information on the avail- Codex,’’ 3d Ed. (1981), p. 35, which is in- ability of this material at NARA, call corporated by reference. Copies may be 202–741–6030, or go to: http:// obtained from the National Academy www.archives.gov/federallregister/ Press, 2101 Constitution Ave. NW., codeloflfederallregulations/ Washington, DC 20418, or may be exam- ibrllocations.html. ined at the National Archives and (c) In accordance with § 184.1(b)(1), Records Administration (NARA). For the ingredient is used in food with no information on the availability of this limitation other than current good material at NARA, call 202–741–6030, or manufacturing practice. The affirma- go to: http://www.archives.gov/ tion of this ingredient as GRAS as a di- federallregister/ rect food ingredient is based upon the codeloflfederallregulations/ following current good manufacturing ibrllocations.html. practice conditions of use: (c) The ingredient is used as an anti- (1) The ingredient is used as an en- microbial agent as defined in zyme as defined in § 170.3(o)(9) of this § 170.3(o)(2) of this chapter, and as a fla- chapter to hydrolyze proteins or voring agent and adjuvant as defined in polypeptides. § 170.3(o)(12) of this chapter. (2) The ingredient is used in food at (d) The ingredient is used in food at levels not to exceed current good man- levels not to exceed good manufac- ufacturing practice. turing practice. Current usage results in a maximum level of 0.1 percent in [60 FR 32910, June 26, 1995, as amended at 78 FR 14666, Mar. 7, 2013] food. (The Food and Drug Administra- tion has not determined whether sig- § 184.1025 Caprylic acid. nificantly different conditions of use (a) Caprylic acid [CH (CH ) COOH, would be GRAS). 3 2 6 CAS Reg. No. 124–07–2] is the chemical (e) Prior sanctions for this ingredient name for octanoic acid. It is considered different from those uses established in to be a short or medium chain fatty this section, or different from that set acid. It occurs normally in various forth in part 181 of this chapter, do not foods and is commercially prepared by exist or have been waived. oxidation of n-octanol or by fermenta- [42 FR 14653, Mar. 15, 1977, as amended at 49 tion and fractional distillation of the FR 5610, Feb. 14, 1984] volatile fatty present in coconut oil. § 184.1024 Bromelain. (b) The ingredient meets the speci- (a) Bromelain (CAS Reg. No. 9001–00– fications of the ‘‘Food Chemicals 7) is an enzyme preparation derived Codex,’’ 3d Ed. (1981), p. 207, which is in- from the pineapples Ananas comosus corporated by reference. Copies may be and A. bracteatus L. It is a white to obtained from the National Academy light tan amorphous powder. Its char- Press, 2101 Constitution Ave. NW.,

492

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00502 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1033

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/ 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) The ingredient is used as a fla- tion of this ingredient as generally rec- voring agent and adjuvant as defined in ognized as safe as a direct human food § 170.3(o)(12) of this chapter. ingredient is based upon the following (d) The ingredient is used in foods in current good manufacturing practice accordance with § 184.1(b)(1), at levels conditions of use: not to exceed good manufacturing (1) The ingredient is used as an en- practice. Current good manufacturing zyme, as defined in § 170.3(o)(9) of this practices result in maximum levels, as chapter, to hydrolyze proteins or car- served, of: 0.013 percent for baked goods bohydrates. as defined in § 170.3(n)(1) of this chap- (2) The ingredient is used in the fol- ter; 0.04 percent for cheeses as defined lowing foods at levels not to exceed in § 170.3(n)(5) of this chapter; 0.005 per- current good manufacturing practice: cent for fats and oils as defined in alcoholic beverages, as defined in § 170.3(n)(12) of this chapter, for frozen § 170.3(n)(2) of this chapter, candy, nu- dairy desserts as defined in § 170.3(n)(20) tritive sweeteners, and protein of this chapter, for gelatins and pud- hydrolyzates. dings as defined in § 170.3(n)(22) of this [48 FR 240, Jan. 4, 1983] chapter, for meat products as defined in § 170.3(n)(29) of this chapter, and for § 184.1033 Citric acid. soft candy as defined in § 170.3(n)(38) of (a) Citric acid (C6H8O7, CAS Reg. No. this chapter; 0.016 percent for snack 77–92–9) is the compound 2-hydroxy- foods as defined in § 170.3(n)(37) of this 1,2,3-propanetricarboxylic acid. It is a chapter; and 0.001 percent or less for all naturally occurring constituent of other food categories. plant and animal tissues. It occurs as (e) Prior sanctions for this ingredient colorless or a white powder different from the uses established in and may be anhydrous or contain one this section do not exist or have been mole of water per mole of citric acid. waived. Citric acid may be produced by recov- [43 FR 19843, May 9, 1978, as amended at 49 ery from sources such as lemon or pine- FR 5611, Feb. 14, 1984] apple juice; by mycological fermenta- tion using Candida spp., described in § 184.1027 Mixed carbohydrase and §§ 173.160 and 173.165 of this chapter; and protease enzyme product. by the solvent extraction process de- (a) Mixed carbohydrase and protease scribed in § 173.280 of this chapter for enzyme product is an enzyme prepara- the recovery of citric acid from Asper- tion that includes carbohydrase and gillus niger fermentation liquor. protease activity. It is obtained from (b) The ingredient meets the speci- the culture filtrate resulting from a fications 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

493

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00503 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1034 21 CFR Ch. I (4–1–15 Edition)

(NARA). For information on the avail- (2) The ingredient is used in food at ability of this material at NARA, call levels not to exceed current good man- 202–741–6030, or go to: http:// ufacturing practice. www.archives.gov/federallregister/ [60 FR 32910, June 26, 1995, as amended at 69 codeloflfederallregulations/ FR 24512, May 4, 2004; 78 FR 14666, Mar. 7, ibrllocations.html. 2013] (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no § 184.1061 Lactic acid. limitations other than current good (a) Lactic acid (C H O , CAS Reg. manufacturing practice. 3 6 3 Nos.: DL mixture, 598–82–3; L-isomer, 79– (d) Prior sanctions for this ingredient 33–4; D-isomer, 10326–41–7), the chemical different from the uses established in 2-hydroxypropanoic acid, occurs natu- this section do not exist or have been rally in several foods. It is produced waived. commercially either by fermentation [59 FR 63895, Dec. 12, 1994] of carbohydrates such as glucose, su- crose, or lactose, or by a procedure in- § 184.1034 Catalase (bovine liver). volving formation of lactonitrile from (a) Catalase (bovine liver) (CAS Reg. acetaldehyde and hydrogen cyanide No. 81457–95–6) is an enzyme prepara- and subsequent hydrolysis to lactic tion obtained from extracts of bovine acid. liver. It is a partially purified liquid or (b) The ingredient meets the speci- powder. Its characterizing enzyme ac- fications of the Food Chemicals Codex, tivity is catalase (EC 1.11.1.6). 3d Ed. (1981), p. 159, which is incor- (b) The ingredient meets the general porated by reference. Copies are avail- requirements and additional require- able from the National Academy Press, ments for enzyme preparations in the 2101 Constitution Avenue, NW., Wash- Food Chemicals Codex, 3d ed. (1981), p. ington, DC 20418, or available for in- 110, which is incorporated by reference spection at the National Archives and in 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 Food Additive Safety (HFS–200), codeloflfederallregulations/ Center for Food Safety and Applied Nu- ibrllocations.html. trition, Food and Drug Administration, (c) In accordance with § 184.1(b)(1), 5100 Paint Branch Pkwy., College Park, the ingredient is used in food with no MD 20740, 240–402–1200, and at the Na- limitation other than current good tional Archives and Records Adminis- manufacturing practice. The affirma- tration (NARA). For information on the availability of this material at tion of this ingredient as generally rec- NARA, call 202–741–6030, or go to: http:// ognized as safe (GRAS) as a direct www.archives.gov/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 an anti- the ingredient is used in food with no microbial agent as defined in limitation other than current good § 170.3(o)(2) of this chapter; a curing and manufacturing practice. The affirma- pickling agent as defined in § 170.3(o)(5) tion of this ingredient as GRAS as a di- of this chapter; a flavor enhancer as de- rect food ingredient is based upon the fined in § 170.3(o)(11) of this chapter; a following current good manufacturing flavoring agent and adjuvant as defined practice conditions of use: in § 170.3(o)(12) of this chapter; a pH (1) The ingredient is used as an en- control agent as defined in § 170.3(o)(23) zyme as defined in § 170.3(o)(9) of this of this chapter; and a solvent and vehi- chapter to decompose hydrogen per- cle as defined in § 170.3(o)(27) of this oxide. chapter.

494

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00504 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1065

(2) The ingredient is used in food, ex- Copies are available from the Office of cept in infant foods and infant for- Food Additive Safety (HFS–200), Center mulas, at levels not to exceed current for Food Safety and Applied Nutrition, good manufacturing practice. Food and Drug Administration, 5100 (d) Prior sanctions for this ingredient Paint Branch Pkwy., College Park, MD different from the uses established in 20740, 240–402–1200, or may be examined this section do not exist or have been at the Center for Food Safety and Ap- waived. plied Nutrition’s Library, 5100 Paint [49 FR 35367, Sept. 7, 1984] Branch Pkwy., College Park, MD 20740, or at the National Archives and § 184.1063 Enzyme-modified lecithin. Records Administration (NARA). For (a) Enzyme-modified lecithin is pre- information on the availability of this pared by treating lecithin with either material at NARA, call 202–741–6030, or phospholipase A2 (EC 3.1.1.4) or pan- go to: http://www.archives.gov/ creatin. federallregister/ (b) The ingredient meets the speci- codeloflfederallregulations/ fications in paragraphs (b)(1) through ibrllocations.html. (b)(8) of this section. Unless otherwise (c) In accordance with § 184.1(b)(1), noted, compliance with the specifica- the ingredient is used in food with no tions listed below is determined ac- limitation other than current good cording to the methods set forth for manufacturing practice. The affirma- lecithin in the Food Chemicals Codex, tion of this ingredient as generally rec- 4th ed. (1996), pp. 220–221, which are in- ognized as safe as a direct human food corporated by reference in accordance ingredient is based upon the following with 5 U.S.C. 552(a) and 1 CFR part 51. current good manufacturing practice Copies are available from the National conditions of use: Academy Press, 2101 Constitution Ave. (1) The ingredient is used as an emul- NW., Washington DC 20418, or may be sifier as defined in § 170.3(o)(8) of this examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 chapter. Paint Branch Pkwy., College Park, MD (2) The ingredient is used at levels 20740, or at the National Archives and not to exceed current good manufac- Records Administration (NARA). For turing practice. information on the availability of this [61 FR 45889, Aug. 30, 1996, as amended at 78 material at NARA, call 202–741–6030, or FR 14666, Mar. 7, 2013] go to: http://www.archives.gov/ federallregister/ § 184.1065 Linoleic acid. codeloflfederallregulations/ (a) Linoleic acid ((Z, Z)–9, 12-octadec- ibr locations.html. l adienoic acid (C H COOH) (CAS Reg. (1) Acetone-insoluble matter 17 31 No. 60–33–3)), a straight chain unsatu- (phosphatides), not less than 50.0 per- rated fatty acid with a molecular cent. weight of 280.5, is a colorless oil at (2) Acid value, not more than 40. (3) Lead, not more than 1.0 part per room temperature. Linoleic acid may million, as determined by atomic ab- be prepared from edible fats and oils by sorption spectroscopy. various methods including hydrolysis (4) Heavy metals (as Pb), not more and saponification, the Twitchell than 20 parts per million. method, low pressure splitting with (5) Hexane-insoluble matter, not catalyst, continuous high pressure more than 0.3 percent. counter current splitting, and medium (6) Peroxide value, not more than 20. pressure autoclave splitting with cata- (7) Water, not more than 4.0 percent. lyst. (8) Lysolecithin, 50 to 80 mole percent (b) The ingredient must be of a pu- of total phosphatides as determined by rity suitable for its intended use. The ‘‘Determination of Lysolecithin Con- ingredient must also meet the speci- tent of Enzyme-Modified Lecithin: fications in § 172.860(b) of this chapter. Method I,’’ dated 1985, which is incor- (c) In accordance with § 184.1(b)(1), porated by reference in accordance the ingredient is used in food with no with 5 U.S.C. 552(a) and 1 CFR part 51. limitation other than current good

495

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00505 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1069 21 CFR Ch. I (4–1–15 Edition)

manufacturing practice. The affirma- (d) The ingredients are used in food, tion of this ingredient as generally rec- except baby food, at levels not to ex- ognized as safe (GRAS) as a direct ceed good manufacturing practice in human food ingredient is based upon accordance with § 184.1(b)(1). Current the following current good manufac- good manufacturing practice results in turing practice conditions of use: a maximum level, as served, of 3.4 per- (1) The ingredient is used as a fla- cent for nonalcoholic beverages as de- voring agent and adjuvant as defined in fined in § 170.3(n)(3) of this chapter; 3.0 § 170.3(o)(12) of this chapter and as a nu- percent for chewing gum as defined in trient supplement as defined in § 170.3(n)(6) of this chapter; 0.8 percent § 170.3(o)(20) of this chapter. for gelatins, puddings, and fillings as (2) The ingredient is used in foods at defined in § 170.3(n)(22) of this chapter; levels not to exceed current good man- 6.9 percent for hard candy as defined in ufacturing practice. The ingredient § 170.3(n)(25) of this chapter; 2.6 percent may be used in infant formula in ac- for jams and jellies as defined in cordance with section 412(g) of the Fed- § 170.3(n)(28) of this chapter; 3.5 percent eral Food, Drug, and Cosmetic Act (the for processed fruits and fruit juices as act) or with regulations promulgated defined in § 170.3(n)(35) of this chapter; under section 412(a)(2) of the act. 3.0 percent for soft candy as defined in (d) Prior sanctions for this ingredient § 170.3(n)(38) of this chapter; and 0.7 per- cent for all other food categories. different from the uses established in (e) Prior sanctions for malic acid dif- this section do not exist or have been ferent from the uses established in this waived. section do not exist or have been [49 FR 48534, Dec. 13, 1984, as amended at 73 waived. FR 8606, Feb. 14, 2008] [44 FR 20656, Apr. 6, 1979, as amended at 49 FR 5611, Feb. 14, 1984] § 184.1069 Malic acid.

(a) Malic acid (C4H6O5, CAS Reg. No. § 184.1077 Potassium acid tartrate. of L-form 97–67–6, CAS Reg. No. of DL- (a) Potassium acid tartrate (C4H5KO6, form 617–48–1) is the common name for CAS Reg. No. 868–14–4) is the potassium 1-hydroxy-1, 2-ethanedicarboxylic acid. of L¥(+)¥tartaric acid and is L (+) malic acid, referred to as L-malic also called or acid, occurs naturally in various foods. cream of tartar. It occurs as colorless Racemic DL-malic acid does not occur or slightly opaque crystals or as a naturally. It is made commercially by white, crystalline powder. It has a hydration of fumaric acid or maleic pleasant, acid taste. It is obtained as a acid. byproduct of wine manufacture. (b) The ingredient meets the speci- (b) The ingredient meets the speci- fications of the ‘‘Food Chemicals fications of the Food Chemicals Codex, Codex,’’ 3d Ed. (1981), pp. 183–184, which 3d Ed. (1981), P. 238, which is incor- is incorporated by reference. Copies porated by reference. Copies are avail- may be obtained from the National able from the National Academy Press, Academy Press, 2101 Constitution Ave. 2101 Constitution Ave. NW., Wash- NW., Washington, DC 20418, or may be ington, DC 20418, or available for in- examined 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) 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

496

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00506 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1090

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 an manufacturing practice. The affirma- anticaking agent as defined in tion of this ingredient as generally rec- § 170.3(o)(1) of this chapter; an anti- ognized as safe (GRAS) as a direct microbial agent as defined in human food ingredient is based upon § 170.3(o)(2) of this chapter; a formula- the following current good manufac- tion aid as defined in § 170.3(o)(14) of turing practice conditions of use: this chapter; a humectant as defined in (1) The ingredient is used as an anti- § 170.3(o)(16) of this chapter; a leavening microbial agent as defined in agent as defined in § 170.3(o)(17) of this § 170.3(o)(2) of this chapter and a fla- chapter; A pH control agent as defined voring agent as defined in § 170.3(o)(12) in § 170.3(o)(23) of this chapter; a proc- of this chapter. essing aid as defined in § 170.3(o)(24) of (2) The ingredient is used in foods at this chapter; a stabilizer and thickener levels not to exceed current good man- as defined in § 170.3(o)(28) of this chap- ufacturing practice. ter; and a surface-active agent as de- (d) Prior sanctions for this ingredient fined in § 170.3(o)(29) of this chapter. different from the uses established in (2) The ingredient is used in the fol- this section do not exist or have been lowing foods at levels not to exceed waived. current good manufacturing practice: [49 FR 13141, Apr. 3, 1984] baked goods as defined in § 170.3(n)(1) of this chapter; confections and frostings § 184.1090 Stearic acid. as defined in § 170.3(n)(9) of this chap- (a) Stearic acid (C H O , CAS Reg. ter; gelatins and puddings as defined in 18 36 2 No. 57–11–4) is a white to yellowish § 170.3(n)(22) of this chapter; hard candy white solid. It occurs naturally as a as defined in § 170.3(n)(25) of this chap- glyceride in tallow and other animal or ter; jams and jellies as defined in vegetable fats and oils and is a prin- § 170.3(n)(28) of this chapter; and soft cipal constituent of most commercially candy as defined in § 170.3(n)(38) of this hydrogenated fats. It is produced com- chapter. mercially from hydrolyzed tallow de- (d) Prior sanctions for this ingredient rived from edible sources or from different from the uses established in hydrolyzed, completely hydrogenated this section do not exist or have been vegetable oil derived from edible waived. sources. [48 FR 52446, Nov. 18, 1983] (b) The ingredient meets the speci- fications of the Food Chemicals Codex, § 184.1081 Propionic acid. 3d Ed. (1981), p. 313, which is incor- (a) Propionic acid (C3H6O2, CAS Reg. porated by reference, and the require- No. 79–09–4) is an oily liquid having a ments of § 172.860(b)(2) of this chapter. slightly pungent, rancid odor. It is Copies of the Food Chemicals Codex manufactured by chemical synthesis or are available from the National Acad- by bacterial fermentation. emy Press, 2101 Constitution Ave. NW., (b) The ingredient meets the speci- Washington, DC 20418, or available for fications of the Food Chemicals Codex, inspection at the National Archives 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

497

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00507 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1091 21 CFR Ch. I (4–1–15 Edition)

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: [44 FR 20657, Apr. 6, 1979, as amended at 49 (1) The ingredient is used as a fla- FR 5611, Feb. 14, 1984] voring agent and adjuvant as defined in § 170.3(o)(12) of this chapter. § 184.1095 Sulfuric acid. (2) The ingredient is used in foods at (a) Sulfuric acid (H2SO4, CAS Reg. levels not to exceed current good man- No. 7664–93–9), also known as oil of vit- ufacturing practice. riol, is a clear, colorless, oily liquid. It (d) Prior sanctions for this ingredient is prepared by reacting sulfur dioxide different from the uses established in (SO2) with oxygen and mixing the re- this section do not exist or have been sultant sulfur trioxide (SO3) with waived. water, or by reacting nitric oxide (NO) with sulfur dioxide and water. [48 FR 52445, Nov. 18, 1983, as amended at 50 (b) The ingredient meets the speci- FR 49536, Dec. 3, 1985; 69 FR 24512, May 4, 2004] fications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), pp. 317–318, which § 184.1091 Succinic acid. is incorporated by reference. Copies may be obtained from the National (a) Succinic acid (C4H6O4, CAS Reg. Academy Press, 2101 Constitution Ave. No. 110–15–6), also referred to as amber NW., Washington, DC 20418, or may be acid and ethylenesuccinic acid, is the examined at the National Archives and chemical 1,4-butanedioic acid. It is Records Administration (NARA). For commercially prepared by hydro- information on the availability of this genation of maleic or fumaric acid. It material at NARA, call 202–741–6030, or can also be produced by aqueous alkali go to: http://www.archives.gov/ or acid hydrolysis of succinonitrile. federallregister/ (b) The ingredient meets the speci- codeloflfederallregulations/ fications of the ‘‘Food Chemicals ibrllocations.html. Codex,’’ 3d Ed. (1981), pp. 314–315, which (c) The ingredient is used as a pH is incorporated by reference. Copies control agent as defined in § 170.3(o)(23) may be obtained from the National of this chapter and processing aid as Academy Press, 2101 Constitution Ave. defined in § 170.3(o)(24) of this chapter. NW., Washington, DC 20418, or may be (d) The ingredient is used in food at examined at the National Archives and levels not to exceed good manufac- Records Administration (NARA). For turing practice in accordance with information on the availability of this § 184.1(b)(1). Current good manufac- material at NARA, call 202–741–6030, or turing practice results in a maximum go to: http://www.archives.gov/ level, as served, of 0.014 percent for al- federallregister/ coholic beverages as defined in codeloflfederallregulations/ § 170.3(n)(2) of this chapter and 0.0003 ibrllocations.html. percent for cheeses as defined in (c) The ingredient is used as a flavor § 170.3(n)(5) of this chapter. enhancer as defined in § 170.3(o)(11) of (e) Prior sanctions for this ingredient this chapter and pH control agent as different from the uses established in defined in § 170.3(o)(23) of this chapter. this section do not exist or have been (d) The ingredient is used in food at waived. levels not to exceed good manufac- [45 FR 6085, Jan. 25, 1980, as amended at 49 turing practice in accordance with FR 5611, Feb. 14, 1984] § 184.1(b)(1). Current good manufac- turing practice results in a maximum § 184.1097 Tannic acid. level, as served, of 0.084 percent in con- (a) Tannic acid (CAS Reg. No. 1401– diments and relishes as defined in 55–4), or hydrolyzable gallotannin, is a § 170.3(n)(8) of this chapter and 0.0061 complex polyphenolic organic struc- percent in meat products as defined in ture that yields gallic acid and either § 170.3(n)(29) of this chapter. glucose or quinic acid as hydrolysis (e) Prior sanctions for this ingredient products. It is a yellowish-white to different from the uses established in light brown substance in the form of an

498

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00508 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1099

amorphous, bulky powder, glistening porated by reference. Copies are avail- scales, or spongy masses. It is also able from the National Academy Press, ordorless, or has a faint characteristic 2101 Constitution Ave. NW., Wash- odor, and has an astringent taste. Tan- ington, DC 20418, or available for in- nic acid is obtained by solvent extrac- spection at the National Archives and tion of nutgalls or excrescences that Records Administration (NARA). For form on the young twigs of Quercus information on the availability of this infectoria Oliver and related species of material at NARA, call 202–741–6030, or Tannic acid is also obtained Quercus. go to: http://www.archives.gov/ by solvent extraction of the seed pods federallregister/ of Tara (Caesalpinia spinosa) or the code of federal regulations/ nutgalls of various sumac species, in- l l l cluding Rhus semialata, R. coriaria, R. ibrllocations.html. galabra, and R. typhia. (c)(1) 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 Codex, within the following specific limita- 3d Ed. (1981), p. 319, which is incor- tions:

Maximum level of use Category of food in food (as Functional use served) (per- cent)

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. Alcoholic beverages, § 170.3(n)(2) of this chapter ...... 0 .015 Flavor enhancer, § 170.3(o)(11) of this chapter; fla- voring agent and adjuvant, § 170.3(o)(12) of this chapter; processing aid, § 170.3(o)(24) of this chap- ter. 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- 3d Ed. (1981), P. 320, which is incor- dered animal fat in accordance with 9 porated by reference. Copies are avail- CFR 318.7. able from the National Academy Press, (d) 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 do not exist or have been spection at the National Archives and waived. Records Administration (NARA). For [50 FR 21043, May 22, 1985] information on the availability of this material at NARA, call 202–741–6030, or § 184.1099 Tartaric acid. go to: http://www.archives.gov/ federallregister/ (a) Food grade tartaric acid (C H O , 4 6 6 codeloflfederallregulations/ CAS Reg. No. 87–69–4) has the L con- ibrllocations.html. figuration. The L form of tartaric acid is dextrorotatory in solution and is (c) In accordance with § 184.1(b)(1), also known as L¥(+)¥tartaric acid. the ingredient is used in food with no Tartaric acid occurs as colorless or limitation other than current good translucent crystals or as a white, manufacturing practice. The affirma- crystalline powder. It is odorless and tion of this ingredient as generally rec- has an acid taste. It is obtained as a ognized as safe (GRAS) as a direct byproduct of wine manufacture. human food ingredient is based upon (b) The ingredient meets the speci- the following current good manufac- fications of the Food Chemicals Codex, turing practice conditions of use:

499

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00509 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1101 21 CFR Ch. I (4–1–15 Edition)

(1) The ingredient is used as a firm- the following current good manufac- ing agent as defined in § 170.3(o)(10) of turing practice conditions of use: this chapter; a flavor enhancer as de- (1) The ingredient is used in food as fined in § 170.3(o)(11) of this chapter; a an emulsifier and emulsifier salt as de- flavoring agent as defined in fined in § 170.3(o)(8) of this chapter and § 170.3(o)(12) of this chapter; a humec- a flavoring agent and adjuvant as de- tant as defined in § 170.3(o)(16) of this fined in § 170.3(o)(12) of this chapter. chapter; and a pH control agent as de- (2) The ingredient is used in the fol- fined in § 170.3(o)(23) of this chapter. lowing foods at levels not to exceed (2) The ingredient is used in foods at current good manufacturing practice: levels not to exceed current good man- baked goods and baking mixes as de- ufacturing practice. fined in § 170.3(n)(l) of this chapter; (d) Prior sanctions for this ingredient nonalcoholic beverages as defined in different from the uses established in § 170.3(n)(3) of this chapter; confections this section do not exist or have been and frostings as defined in § 170.3(n)(9) waived. of this chapter; dairy product analogs as defined in § 170.3(n)(10) of this chap- [48 FR 52447, Nov. 18, 1983, as amended at 50 ter; and fats and oils as defined in FR 49536, Dec. 3, 1985] § 170.3(n)(12) of this chapter. (d) Prior sanctions for this ingredient § 184.1101 Diacetyl tartaric acid esters different from the uses established in of mono- and diglycerides. this section do not exist or have been (a) Diacetyl tartaric acid esters of waived. mono- and diglycerides, also know as (e) Labeling: The acronym ‘‘DATEM’’ DATEM, are composed of mixed esters may be used on food labeling as the al- of glycerin in which one or more of the ternate common or usual name for the hydroxyl groups of glycerin has been ingredient diacetyl tartaric acid esters esterified by diacetyl tartaric acid and of mono- and diglycerides. by fatty acids. The ingredient is pre- [54 FR 7403, Feb. 21, 1989, as amended at 54 pared by the reaction of diacetyl tar- FR 13168, Mar. 31, 1989; 54 FR 18382, Apr. 28, taric anhydride with mono- and 1989; 60 FR 15872, Mar. 28, 1995] diglycerides that are derived from edi- ble sources. § 184.1115 Agar-agar. (b) The ingredient meets the speci- (a) Agar-agar (CAS Reg. No. PM 9002– fications of the Food Chemicals Codex, 18–0) is a dried, hydrophyllic, colloidal 3d. Ed. (1981), pp. 98–99, which is incor- polysaccharide extracted from one of a porated by reference in accordance number of related species of red algae with 5 U.S.C. 552(a). Copies are avail- (class Rhodophyceae). able from the National Academy Press, (b) The ingredient meets the speci- 2101 Constitution Avenue NW., Wash- fications of the ‘‘Food Chemicals ington, DC 20418, or available for in- Codex,’’ 3d Ed. (1981), p. 11, which is in- spection at the National Archives and corporated by reference. Copies may be Records Administration (NARA). For obtained from the National Academy information on the availability of this Press, 2101 Constitution Ave. NW., material at NARA, call 202–741–6030, or Washington, DC 20418, or may be exam- go to: http://www.archives.gov/ ined 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) The ingredient is used in food in ognized as safe (GRAS) as a direct accordance with § 184.1(b)(2) under the human food ingredient is based upon following conditions:

500

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00510 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1121

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; sta- bilizer, thickener, § 170.3(o)(28) of this chapter; sur- face 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; formu- lation 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 Maximum level of Category of food use in food (as Functional use different from the uses established in served) this section do not exist or have been waived. Spices, Not to exceed cur- Flavor enhancer, seasonings, and rent good manu- § 170.3(o)(11) of [44 FR 19391, Apr. 3, 1979, as amended at 49 flavorings, facturing prac- this chapter; fla- § 170.3(n) (26) tice. vor adjuvant, FR 5611, Feb. 14, 1984] of this chapter. § 170.3(o)(12) of this chapter. § 184.1120 Brown algae. (a) Brown algae are seaweeds of the (d) Prior sanctions for this ingredient species Analipus japonicus, Eisenia different from the use established in bicyclis, Hizikia fusiforme, Kjellmaniella this section do not exist or have been waived. gyrata, Laminaria angustata, Laminaria claustonia, Laminaria digitata, Lam- [47 FR 47376, Oct. 26, 1982] inaria japonica, Laminaria longicruris, Laminaria longissima, Laminaria § 184.1121 Red algae. ochotensis, Laminaria saccharina, (a) Red algae are seaweeds of the spe- Macrocystis pyrifera, Petalonia fascia, cies Gloiopeltis furcata, Porphyra Scytosiphon lomentaria and Undaria crispata, Porphyra deutata, Porphyra pinnatifida. They are harvested prin- perforata, Porphyra suborbiculata, cipally in coastal waters of the north- Porphyra tenera and Rhodymenia ern Atlantic and Pacific oceans. The palmata. Porphyra and Rhodymenia are harvested principally along the coasts material is dried and ground or of Japan, Korea, China, Taiwan, and chopped for use in food. the East and West coasts of the United (b) The ingredient meets the speci- States. Gloiopeltis is harvested prin- fications for kelp in the Food Chemi- cipally in southern Pacific coastal cals Codex, 3d Ed. (1981), p. 157, which is waters. The material is dried and incorporated by reference. Copies are ground or chopped for use in food. available from the National Academy (b) The ingredient meets the speci- Press, 2101 Constitution Ave. NW., fications for kelp in the Food Chemi- Washington, DC 20418, or available for cals Codex, 3d Ed. (1981), p. 157, which is inspection at the National Archives incorporated by reference, except that and Records Administration (NARA). the loss on drying is not more than 20 For information on the availability of percent and the maximum allowable this material at NARA, call 202–741– level for iodine is 0.05 percent. Copies 6030, or go to: http://www.archives.gov/ are available from the National Acad- federallregister/ emy Press, 2101 Constitution Ave. NW., codeloflfederallregulations/ Washington, DC 20418, or available for inspection at the National Archives ibrllocations.html. and Records Administration (NARA). (c) In accordance with § 184.1(b)(2), For information on the availability of the ingredient is used in food only this material at NARA, call 202–741– within the following specific limita- 6030, or go to: http://www.archives.gov/ tions: federallregister/

501

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00511 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1133 21 CFR Ch. I (4–1–15 Edition)

codeloflfederallregulations/ Maximum ibr locations.html. level of l use in (c) In accordance with § 184.1(b)(2), Category of food food (as Functional use the ingredient is used in food only served) (percent) within the following specific limita- tions: Gelatins, puddings, 0.5 Do. § 170.3(n)(22) of this Maximum level of chapter. Category of food use in food (as Functional use Gravies and sauces, 0.4 Do. served) § 170.3(n)(24) of this chapter. Spices, Not to exceed cur- Flavor enhancer, Jams and jellies, 0.4 Do. seasonings, and rent good manu- § 170.3(o)(11) of § 170.3(n)(28) of this flavorings, facturing prac- this chapter; fla- chapter. § 170.3(n) (26) tice. vor adjuvant, Sweet sauces, 0.5 Do. of this chapter. § 170.3(o)(12) of § 170.3(n)(43) of this this chapter. chapter. All other food cat- 0.1 Humectant, (d) Prior sanctions for this ingredient egories. § 170.3(o)(16) of this different from the use established in chapter; stabilizer, thickener, this section do not exist or have been § 170.3(o)(28) of this waived. chapter. [47 FR 47376, Oct. 26, 1982] (d) Prior sanctions for ammonium al- § 184.1133 Ammonium alginate. ginate different from the uses estab- lished in this section do not exist or (a) Ammonium alginate (CAS Reg. have been waived. No. 9005–34–9) is the ammonium salt of alginic acid, a natural polyuronide con- [47 FR 29950, July 9, 1982] stituent of certain brown algae. Ammo- nium alginate is prepared by the neu- § 184.1135 Ammonium bicarbonate. tralization of purified alginic acid with (a) Ammonium bicarbonate appropriate pH control agents. (NH4HCO3, CAS Reg. No. 1066–33–7) is (b) The ingredient meets the speci- prepared by reacting gaseous carbon di- fications of the Food Chemicals Codex, oxide with aqueous ammonia. Crystals 3d Ed. (1981), p. 18, which is incor- of ammonium bicarbonate are precip- porated by reference. Copies are avail- itated from solution and subsequently able from the National Academy Press, washed and dried. 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. 19, 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)(2), material at NARA, call 202–741–6030, or the ingredient is used in food only go to: http://www.archives.gov/ within the following specific limita- federallregister/ tions: codeloflfederallregulations/ Maximum ibrllocations.html. level of (c) In accordance with § 184.1(b)(1), use in Category of food food (as Functional use the ingredient is used in food with no served) limitation other than current good (percent) manufacturing practice. The affirma- Confections, frostings, 0.4 Stabilizer, thickener, tion of this ingredient as generally rec- § 170.3(n)(9) of this § 170.3(o)(28) of this ognized as safe (GRAS) as a direct chapter. chapter. human food ingredient is based upon Fats and oils, 0.5 Do. § 170.3(n)(12) of this the following current good manufac- chapter. turing practice conditions of use:

502

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00512 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1138

(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 of this chapter; a leavening agent as this section do not exist or have been defined in § 170.3(o)(17) of this chapter; waived. a pH control agent as defined in § 170.3(o)(23) of this chapter; and a [48 FR 52439, Nov. 18, 1983] texturizer as defined in § 170.3(o)(32) of § 184.1138 Ammonium chloride. this chapter. (2) The ingredient is used in food at (a) Ammonium chloride (NH4Cl, CAS levels not to exceed current good man- Reg. No. 12125–02–9) is produced by the ufacturing practice. reaction of sodium chloride and an am- (d) Prior sanctions for this ingredient monium salt in solution. The less solu- different from the uses established in ble sodium salt separates out at ele- this section do not exist or have been vated temperatures, and ammonium waived. chloride is recovered from the filtrate on cooling. Alternatively, hydrogen [48 FR 52439, Nov. 18, 1983] chloride formed by the burning of hy- § 184.1137 Ammonium carbonate. drogen in chlorine is dissolved in water and then reacted with gaseous ammo- (a) Ammonium carbonate ((NH4)2CO3, nia. Ammonium chloride is crystallized CAS Reg. No. 8000–73–5) is a mixture of from the solution. ammonium bicarbonate (NH4HCO3) and (b) The ingredient meets the speci- ammonium carbamate (NH2COONH4). fications of the Food Chemicals Codex, It is prepared by the sublimation of a 3d Ed. (1981), p. 20, which is incor- mixture of ammonium sulfate and cal- porated by reference. Copies are avail- cium carbonate and occurs as a white able from the National Academy Press, powder or a hard, white or translucent 2101 Constitution Ave, NW., Wash- mass. 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- 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 dough tion of this ingredient as generally rec- strengthener as defined in § 170.3(o)(6) ognized as safe (GRAS) as a direct of this chapter; a flavor enhancer as de- human food ingredient is based upon fined in § 170.3(o)(11) of this chapter; a the following current good manufac- leavening agent as defined in turing practice conditions of use: § 170.3(o)(17) of this chapter; and a proc- (1) The ingredient is used as a leav- essing aid as defined in § 107.3(o)(24) of ening agent as defined in § 170.3(o)(17) of this chapter. this chapter and a pH control agent as (2) The ingredient is used in food at defined in § 170.3(o)(23) of this chapter. levels not to exceed current good man- (2) The ingredient is used in food at ufacturing practice. levels not to exceed current good man- (d) Prior sanctions for this ingredient ufacturing practice. different from the uses established in

503

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00513 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1139 21 CFR Ch. I (4–1–15 Edition)

this section do not exist or have been It is prepared by partially neutralizing waived. citric acid with ammonia. (b) The ingredient must be of a pu- [48 FR 52439, Nov. 18, 1983] rity suitable for its intended use. (c) In accordance with § 184.1(b)(1), § 184.1139 Ammonium hydroxide. the ingredient is used in food with no (a) Ammonium hydroxide (NH4OH, limitation other than current good CAS Reg. No. 1336–21–6) is produced by manufacturing practice. The affirma- passing ammonia gas into water. tion of this ingredient as generally rec- (b) The ingredient meets the speci- ognized as safe (GRAS) as a direct fications of the Food Chemicals Codex, human food ingredient is based upon 3d Ed. (1981), p. 20, which is incor- the following current good manufac- porated by reference. Copies are avail- turing practice conditions of use: able from the National Academy Press, (1) The ingredient is used as a flavor 2101 Constitution Ave. NW., Wash- enhancer as defined in § 170.3(o)(11) of ington, DC 20418, or available for in- this chapter and as a pH control agent spection at the National Archives and as defined in § 170.3(o)(23) of this chap- Records Administration (NARA). For ter. information on the availability of this (2) The ingredient is used in non- material at NARA, call 202–741–6030, or alcoholic beverages as defined in go to: http://www.archives.gov/ § 170.3(n)(3) of this chapter and in federallregister/ cheeses as defined in § 170.3(n)(5) of this codeloflfederallregulations/ chapter at levels not to exceed current ibrllocations.html. good 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, or different from those set manufacturing practice. The affirma- forth in part 181 of this chapter, do not tion of this ingredient as generally rec- exist or have been waived. ognized as safe (GRAS) as a direct [59 FR 63896, Dec. 12, 1994, as amended at 73 human food ingredient is based upon FR 8606, Feb. 14, 2008] the following current good manufac- turing practice conditions of use: § 184.1141a Ammonium phosphate, (1) The ingredient is used as a leav- monobasic. ening agent as defined in § 170.3(o)(17) of (a) Ammonium phosphate, monobasic this chapter; a pH control agent as de- (NH4H2PO4, CAS Reg. No. 7722–76–1) is fined in § 170.3(o)(23) of this chapter; a manufactured by reacting ammonia surface-finishing agent as defined in with phosphoric acid at a pH below 5.8. § 170.3(o)(30) of this chapter; and as a (b) The ingredient meets the speci- boiler water additive complying with fications of the Food Chemicals Codex, § 173.310 of this chapter. 3d Ed. (1981), p. 21, which is incor- (2) The ingredient is used in food at porated by reference. Copies are avail- levels not to exceed current good man- able from the National Academy Press, ufacturing practice. The ingredient 2101 Constitution Ave. NW., Wash- may also be used as a boiler water ad- ington, DC 20418, or available for in- ditive at levels not to exceed current spection at the National Archives and good manufacturing practice. Records Administration (NARA). For (d) Prior sanctions for this ingredient information on the availability of this different from the uses established in material at NARA, call 202–741–6030, or 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 ibrllocations.html. FR 14551, Mar. 29, 1994] (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no § 184.1140 Ammonium citrate, dibasic. 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

504

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00514 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1148

human food ingredient is based upon (d) Prior sanctions for this ingredient the following current good manufac- different from the uses established in turing practice conditions of use: this section do not exist or have been (1) The ingredient is used as a dough waived. strengthener as defined in § 170.3(o)(6) of this chapter and a pH control agent [48 FR 52440, Nov. 18, 1983] as defined in § 170.3(o)(23) of this chap- § 184.1143 Ammonium sulfate. ter. (2) The ingredient is used in food at (a) Ammonium sulfate ((NH4)2SO4, levels not to exceed current good man- CAS Reg. No. 7783–20–2) occurs natu- ufacturing practice. rally and consists of colorless or white, (d) Prior sanctions for this ingredient odorless crystals or granules. It is pre- different from the uses established in pared by the neutralization of sulfuric this section do not exist or have been acid with ammonium hydroxide. waived. (b) The ingredient meets the speci- fications of the ‘‘Food Chemicals [48 FR 52440, Nov. 18, 1983] Codex,’’ 3d Ed. (1981), pp. 22–23, which is § 184.1141b Ammonium phosphate, di- incorporated by reference. Copies may basic. be obtained from the National Acad- emy Press, 2101 Constitution Ave. NW., (a) Ammonium phosphate, dibasic Washington, DC 20418, or may be exam- ((NH4)2HPO4, CAS Reg. No. 7783–28–0) is ined at the National Archives and manufactured by reacting ammonia Records Administration (NARA). For with phosphoric acid at a pH above 5.8. 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. 21, which is incor- federallregister/ porated by reference. Copies are avail- codeloflfederallregulations/ able from the National Academy Press, ibr locations.html. 2101 Constitution Ave. NW., Wash- l (c) The ingredient is used as a dough ington, DC 20418, or available for in- strengthener as defined in § 170.3(o)(6) spection at the National Archives and of this chapter, firming agent as de- Records Administration (NARA). For fined in § 170.3(o)(10) of this chapter, information on the availability of this and processing aid as defined in material at NARA, call 202–741–6030, or § 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. (c) In accordance with § 184.1(b)(1), § 184.1(b)(1). Current good manufac- the ingredient is used in food with no turing practice results in a maximum limitation other than current good level, as served, of 0.15 percent for manufacturing practice. The affirma- baked goods as defined in § 170.3(n)(1) of tion of this ingredient as generally rec- this chapter and 0.1 percent for gela- ognized as safe (GRAS) as a direct tins and puddings as defined in human food ingredient is based upon § 170.1(n)(22) of this chapter. the following current good manufac- (e) Prior sanctions for this ingredient turing practice conditions of use: different from the uses established in (1) The ingredient is used as a dough this section do not exist or have been strengthener as defined in § 170.3(o)(6) waived. of this chapter; a firming agent as de- [45 FR 6086, Jan. 25, 1980; 45 FR 16469, Mar. 14, fined in § 170.3(o)(10) of this chapter; a 1980, as amended at 49 FR 5611, Feb. 14, 1984] leavening agent as defined in § 170.3(o)(17) of this chapter; a pH con- § 184.1148 Bacterially-derived trol agent as defined in § 170.3(o)(23) of carbohydrase enzyme preparation. this chapter; and a processing aid as (a) Bacterially-derived carbohydrase defined in § 170.3(o)(24) of this chapter. enzyme preparation is obtained from (2) The ingredient is used in food at the culture filtrate resulting from a levels not to exceed current good man- pure culture fermentation of a non- ufacturing practice. pathogenic and nontoxigenic strain of

505

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00515 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1150 21 CFR Ch. I (4–1–15 Edition)

Bacillus subtilis or B. amyloliquefaciens. (2) The ingredient is used in food at The preparation is characterized by the levels not to exceed current good man- presence of the enzymes a-amylase (EC ufacturing practice. 3.2.1.1) and b-glucanase (EC 3.2.1.6), [64 FR 19894, Apr. 23, 1999] which catalyze the hydrolysis of O- glycosyl bonds in carbohydrates. § 184.1150 Bacterially-derived protease (b) The ingredient meets the general enzyme preparation. requirements and additional require- (a) Bacterially-derived protease en- ments in the monograph on enzyme zyme preparation is obtained from the preparations in the Food Chemicals culture filtrate resulting from a pure Codex, 4th ed. (1996), pp. 128–135, which culture fermentation of a nonpatho- is incorporated by reference in accord- genic and nontoxigenic strain of Bacil- ance with 5 U.S.C. 552(a) and 1 CFR lus subtilis or B. amyloliquefaciens. The part 51. Copies are available from the preparation is characterized by the National Academy Press, 2101 Constitu- presence of the enzymes subtilisin (EC tion Ave. NW., Washington, DC 20418, 3.4.21.62) and neutral proteinase (EC or may be examined at the Center for 3.4.24.28), which catalyze the hydrolysis Food Safety and Applied Nutrition’s of peptide bonds in proteins. Library, 5100 Paint Branch Pkwy., Col- (b) The ingredient meets the general lege Park, MD 20740, or at the National requirements and additional require- Archives and Records Administration ments in the monograph on enzyme (NARA). For information on the avail- preparations in the Food Chemicals ability of this material at NARA, call Codex, 4th ed. (1996), pp. 128–135, which 202–741–6030, or go to: http:// is incorporated by reference in accord- www.archives.gov/federallregister/ ance with 5 U.S.C. 552(a) and 1 CFR codeloflfederallregulations/ part 51. Copies are available from the ibrllocations.html. In addition, anti- National Academy Press, 2101 Constitu- biotic activity is absent in the enzyme tion Ave. NW., Washington, DC 20418, preparation when determined by an ap- or may be examined at the Center for propriate validated method such as the Food Safety and Applied Nutrition’s method ‘‘Determination of antibiotic Library, 5100 Paint Branch Pkwy., Col- activity’’ in the Compendium of Food lege Park, MD 20740, or at the National Additive Specifications, vol. 2, Joint Archives and Records Administration FAO/WHO Expert Committee on Food (NARA). For information on the avail- Additives (JECFA), Food and Agri- ability of this material at NARA, call culture Organization of the United Na- 202–741–6030, or go to: http:// tions, Rome, 1992. Copies are available www.archives.gov/federallregister/ from Bernan Associates, 4611–F Assem- codeloflfederallregulations/ bly Dr., Lanham, MD 20706, or from The ibrllocations.html. In addition, anti- United Nations Bookshop, General As- biotic activity is absent in the enzyme sembly Bldg., rm. 32, New York, NY preparation when determined by an ap- 10017, or by inquiries sent to http:// propriate validated method such as the www.fao.org. Copies may be examined method ‘‘Determination of antibiotic at the Center for Food Safety and Ap- activity’’ in the Compendium of Food plied Nutrition’s Library, 5100 Paint Additive Specifications, vol. 2, Joint Branch Pkwy., College Park, MD 20740. FAO/WHO Expert Committee on Food (c) In accordance with § 184.1(b)(1), Additives (JECFA), Food and Agri- the ingredient is used in food with no culture Organization of the United Na- limitation other than current good tions, Rome, 1992. Copies are available manufacturing practice. The affirma- from Bernan Associates, 4611–F Assem- tion of this ingredient as GRAS as a di- bly Dr., Lanham, MD 20706, or from The rect food ingredient is based upon the United Nations Bookshop, General As- following current good manufacturing sembly Bldg., rm. 32, New York, NY practice conditions of use: 10017, or by inquiries sent to http:// (1) The ingredient is used as an en- www.fao.org. Copies may be examined zyme as defined in § 170.3(o)(9) of this at the Center for Food Safety and Ap- chapter to hydrolyze polysaccharides plied Nutrition’s Library, 5100 Paint (e.g., starch). Branch Pkwy., College Park, MD 20740.

506

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00516 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1157

(c) In accordance with § 184.1(b)(1), § 184.1157 Benzoyl peroxide. the ingredient is used in food with no (a) Benzoyl peroxide ((C6H5CO)2O2, limitation other than current good CAS Reg. No. 94–36–0) is a colorless, manufacturing practice. The affirma- rhombic crystalline solid. It is pre- tion of this ingredient as GRAS as a di- pared by reaction of benzoyl chloride, rect food ingredient is based upon the sodium hydroxide, and hydrogen per- following current good manufacturing oxide. practice conditions of use: (b) The ingredient meets the speci- (1) The ingredient is used as an en- fications of the Food Chemicals Codex, zyme as defined in § 170.3(o)(9) of this 3d Ed. (1981), p. 35, which is incor- chapter to hydrolyze proteins or porated by reference. Copies are avail- polypeptides. able from the National Academy Press, (2) The ingredient is used in food at 2101 Constitution Ave. NW., Wash- levels not to exceed current good man- ington, DC 20418, or available for in- ufacturing practice. spection at the National Archives and Records Administration (NARA). For [64 FR 19895, Apr. 23, 1999] information on the availability of this material at NARA, call 202–741–6030, or § 184.1155 Bentonite. go to: http://www.archives.gov/ (a) Bentonite (Al2O34SiO2nH2O, CAS federallregister/ Reg. No. 1302–78–9) is principally a col- codeloflfederallregulations/ loidal hydrated aluminum silicate. ibrllocations.html. Bentonite contains varying quantities (c) In accordance with § 184.1(b)(1), of iron, alkalies, and alkaline earths in the ingredient is used in food with no the commercial products. Depending on limitation other than current good the cations present, natural deposits of manufacturing practice. The affirma- bentonite range in color from white to tion of this ingredient as generally rec- gray, yellow, green, or blue. ognized as safe (GRAS) as a direct Bentonite’s fine particles provide large human food ingredient is based upon the following current good manufac- total surface area and, hence, pro- turing practice conditions of use: nounced adsorptive capability. (1) The ingredient is used as a bleach- (b) The ingredient must be of a pu- ing agent in food. rity suitable for its intended use. (2) The ingredient is used in the fol- (c) In accordance with § 184.1(b)(1), lowing foods at levels not to exceed the ingredient is used in food with no current good manufacturing practice: limitation other than current good flour; milk used for production of manufacturing practice. The affirma- Asiago fresh and Asiago soft cheese tion of this ingredient as generally rec- (§ 133.102), Asiago medium cheese ognized as safe (GRAS) as a direct (§ 133.103), Asiago old cheese (§ 133.104), human food ingredient is based upon Blue cheese (§ 133.106), Caciocavallo the following current good manufac- siciliano chesse (§ 133.111), Gorgonzola turing practice conditions of use: cheese (§ 133.141), Parmesan and (1) The ingredient is used as a proc- reggiano cheese (§ 133.165), Provolone essing aid as defined in § 170.3(o)(24) of cheese (§ 133.181), Romano cheese this chapter. (§ 133.183), and Swiss and emmentaler (2) The ingredient is used in food at cheese (§ 133.195) in part 133 of this levels not to exceed current good man- chapter; and annatto-colored whey, ufacturing practice. Current good man- such that the final bleached product 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; 76 FR 59249, Sept. 26, 2011] [51 FR 27173, July 30, 1986]

507

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00517 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1165 21 CFR Ch. I (4–1–15 Edition)

§ 184.1165 n-Butane and iso-butane. codeloflfederallregulations/ ibr locations.html. (a) n-Butane and iso-butane (empir- l (c) The ingredient is used as a firm- ical formula C4H10, CAS Reg. Nos. 106– 97–8 and 75–28–5, respectively) are color- ing agent as defined in § 170.3(o)(10) of less, flammable gases at normal tem- this chapter; pH control agent as de- peratures and pressures. They are eas- fined in § 170.3(o)(23) of this chapter; ily liquefied under pressure at room processing aid as defined in § 170.3(o)(24) temperature and are stored and shipped of this chapter; sequestrant as defined in the liquid state. The butanes are ob- in § 170.3(o)(26) of this chapter; sta- tained from natural gas by fraction- bilizer and thickener as defined in ation following absorption in oil, ad- § 170.3(o)(28) of this chapter; and sorption to surface-active agents, or re- texturizer as defined in § 170.3(o)(32) of frigeration. this chapter. (b) The ingredients must be of a pu- (d) The ingredient is used in food at rity suitable for their intended use. levels not to exceed current good man- (c) In accordance with § 184.1(b)(1), ufacturing practices in accordance these ingredients are used in food with with § 184.1(b)(1). Current good manu- no limitations other than current good facturing practices result in a max- manufacturing practice. The affirma- imum level, as served, of 0.2 percent for tion of these ingredients as generally baked goods as defined in § 170.3(n)(1) of recognized as safe (GRAS) as direct this chapter; 0.02 percent for cheese as human food ingredients is based upon defined in § 170.3(n)(5) of this chapter; the following current good manufac- 0.2 percent for gelatins, puddings, and turing practice conditions of use: fillings as defined in § 170.3(n)(22) of (1) The ingredients are used as pro- this chapter; 0.15 percent for sweet pellants, aerating agents, and gases as sauces, toppings, and as defined defined in § 170.3(o)(25) of this chapter. in § 170.3(n)(43) of this chapter; and (2) The ingredients are used in food 0.0001 percent for all other food cat- at levels not to exceed current good egories. manufacturing practice. (e) Prior sanctions for this ingredient (d) Prior sanctions for these ingredi- different from the uses established in ents different from the uses established this section or in part 181 of this chap- in this section do not exist or have ter do not exist or have been waived. been waived. [47 FR 27807, June 25, 1982] [48 FR 57270, Dec. 29, 1983, as amended at 73 FR 8607, Feb. 14, 2008; 76 FR 59249, Sept. 26, § 184.1187 Calcium alginate. 2011] (a) Calcium alginate (CAS Reg. No. 9005–35–0) is the calcium salt of alginic § 184.1185 Calcium acetate. acid, a natural polyuronide constituent (a) Calcium acetate (Ca (C2H3O2)2, of certain brown algae. Calcium algi- CAS Reg. No. 62–54–4), also known as nate is prepared by the neutralization acetate of lime or , is the of purified alginic acid with appro- calcium salt of acetic acid. It may be priate pH control agents, or from so- produced by the calcium hydroxide dium alginate by metathesis with ap- neutralization of acetic acid. propriate calcium salts. (b) The ingredient meets the speci- (b) The ingredient meets the speci- fications of the Food Chemicals Codex, fications of the Food Chemicals Codex, 3d Ed. (1981), p. 44, which is incor- 3d Ed. (1981), p. 45, which is incor- porated by reference. Copies are avail- porated by reference. Copies are avail- able 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 in- spection 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/

508

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00518 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1193

codeloflfederallregulations/ 2101 Constitution Ave. NW., Wash- ibrllocations.html. ington, DC 20418, or available for in- (c) In accordance with § 184.1(b)(2), spection at the National Archives and the ingredient is used in food only Records Administration (NARA). For within the following specific limita- information on the availability of this tions: material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ Maximum level of federallregister/ use in codeloflfederallregulations/ Category of food food (as Functional use served) ibrllocations.html. (percent) (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no Baked goods, 0.002 Stabilizer, thickener, § 170.3(n)(1) of this § 170.3(o)(28) of this limitation other than current good chapter. chapter. manufacturing practice. Alcoholic beverages, 0.4 Do. (d) Prior sanctions for this ingredient § 170.3(n)(2) of this different from the uses established in chapter. Confections and 0.4 Do. this section, or different from that set frostings, forth in part 181 of this chapter, do not § 170.3(n)(9) of this exist or have been waived. chapter. Egg products, 0.6 Do. [48 FR 52441, Nov. 18, 1983] § 170.3(n)(11) of this chapter. § 184.1193 Calcium chloride. Fats and oils, 0.5 Do. § 170.3(n)(12) of this (a) Calcium chloride (CaCl2·2H2O, chapter. CAS Reg. No. 10035–04–8) or anhydrous Gelatins, puddings, 0.25 Do. § 170.3(n)(22) of this calcium chloride (CaCl2, CAS Reg. No. chapter. 10043–52–4) may be commercially ob- Gravies and sauces, 0.4 Do. tained as a byproduct in the ammonia- § 170.3(n)(24) of this chapter. soda (Solvay) process and as a joint Jams and jellies, 0.5 Do. product from natural salt brines, or it § 170.3(n)(28) of this may be prepared by substitution reac- chapter. tions with other calcium and chloride Sweet sauces, 0.5 Do. § 170.3(n)(43) of this salts. chapter. (b) The ingredient meets the speci- All other food cat- 0.3 Do. fications of the Food Chemicals Codex, egories. 3d Ed. (1981), p. 47, which is incor- porated by reference. Copies are avail- (d) Prior sanctions for calcium algi- able from the National Academy Press, nate different from the uses established 2101 Constitution Ave. NW., Wash- in this section do not exist or have ington, DC 20418, or available for in- been waived. spection at the National Archives and [47 FR 29951, July 9, 1982] Records Administration (NARA). For information on the availability of this § 184.1191 Calcium carbonate. material at NARA, call 202–741–6030, or (a) Calcium carbonate (CaCO3, CAS go to: http://www.archives.gov/ Reg. No. 471–34–1) is prepared by three federallregister/ common methods of manufacture: codeloflfederallregulations/ (1) As a byproduct in the ‘‘Lime soda ibrllocations.html. process’’; (c) The ingredient is used as an (2) By precipitation of calcium car- anticaking agent as defined in bonate from calcium hydroxide in the § 170.3(o)(1) of this chapter; anti- ‘‘Carbonation process’’; or microbial agent as defined in (3) By precipitation of calcium car- § 170.3(o)(2) of this chapter; curing or bonate from calcium chloride in the pickling agent as defined in § 170.3(o)(5) ‘‘Calcium chloride process’’. of this chapter; firming agent as de- (b) The ingredient meets the speci- fined in § 170.3(o)(10) of this chapter; fications of the Food Chemicals Codex, flavor enhancer as defined in 3d Ed. (1981), p. 46, which is incor- § 170.3(o)(11) of this chapter; humectant porated by reference. Copies are avail- as defined in § 170.3(o)(16) of this chap- able from the National Academy Press, ter; nutrient supplement as defined in

509

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00519 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1195 21 CFR Ch. I (4–1–15 Edition)

§ 170.3(o)(20) of this chapter; pH control (b) The ingredient meets the speci- agent as defined in § 170.3(o)(23) of this fications of the Food Chemicals Codex, chapter; processing aid as defined in 3d ed. (1981), pp. 49 and 50, which is in- § 170.3(o)(24) of this chapter; stabilizer corporated by reference in accordance and thickener as defined in § 170.3(o)(28) with 5 U.S.C. 552(a) and 1 CFR part 51. of this chapter; surface-active agent as Copies are available from the National defined in § 170.3(o)(29) of this chapter; Academy Press, 2101 Constitution Ave. synergist as defined in § 170.3(o)(31) of NW., Washington, DC 20418, and the this chapter; and texturizer as defined Center for Food Safety and Applied Nu- in § 170.3(o)(32) of this chapter. trition (HFS–200), 5100 Paint Branch (d) The ingredient is used in foods at Pkwy., College Park, MD 20740, or may levels not to exceed current good man- be examined at the National Archives ufacturing practices in accordance and Records Administration (NARA). with § 184.1(b)(1). Current good manu- For information on the availability of facturing practices result in a max- this material at NARA, call 202–741– imum level, as served, of 0.3 percent for 6030, or go to: http://www.archives.gov/ baked goods as defined in § 170.3(n)(1) of federallregister/ this chapter and for dairy product codeloflfederallregulations/ analogs as defined in § 170.3(n)(10) of ibrllocations.html. this chapter; 0.22 percent for non- (c) In accordance with § 184.1(b)(1), alcoholic beverages and beverage bases the ingredient is used in food with no as defined in § 170.3(n)(3) of this chap- limitation other than current good ter; 0.2 percent for cheese as defined in manufacturing practice. Calcium cit- § 170.3(n)(5) of this chapter and for proc- rate may also be used in infant formula essed fruit and fruit juices as defined in in accordance with section 412(g) of the § 170.3(n)(35) of this chapter; 0.32 per- Federal Food, Drug, and Cosmetic Act cent for coffee and tea as defined in (the act) or with regulations promul- § 170.3(n)(7) of this chapter; 0.4 percent gated under section 412(a)(2) of the act. for condiments and relishes as defined (d) Prior sanctions for this ingredient in § 170.3(n)(8) of this chapter; 0.2 per- different from the uses established in cent for gravies and sauces as defined this section do not exist or have been in § 170.3(n)(24) of this chapter; 0.1 per- waived. cent for commercial jams and jellies as [59 FR 63896, Dec. 12, 1994] defined in § 170.3(n)(28) of this chapter; 0.25 percent for meat products as de- § 184.1199 Calcium gluconate. fined in § 170.3(n)(29) of this chapter; 2.0 (a) Calcium gluconate percent for plant protein products as ([CH OH(CHOH) COO] Ca, CAS Reg. No. defined in § 170.3(n)(33) of this chapter; 2 4 2 299–28–5) is the calcium salt of gluconic 0.4 percent for processed vegetables and acid which may be produced by neu- vegetable juices as defined in tralization of gluconic acid with lime § 170.3(n)(36) of this chapter; and 0.05 or calcium carbonate. percent for all other food categories. (b) The ingredient meets the speci- (e) Prior sanctions for this ingredient fications of the Food Chemicals Codex, different from the uses established in 3d Ed. (1981), p. 51, which is incor- this section do not exist or have been porated by reference. Copies are avail- waived. able from the National Academy Press, [47 FR 27808, June 25, 1982, as amended at 61 2101 Constitution Ave. NW., Wash- FR 14247, Apr. 1, 1996] ington, DC 20418, or available for in- spection at the National Archives and § 184.1195 Calcium citrate. Records Administration (NARA). For (a) Calcium citrate information on the availability of this (Ca3(C6H5O7)2·4H2O, CAS Reg. No. 813– material at NARA, call 202–741–6030, or 0994–095) is the calcium salt of citric go to: http://www.archives.gov/ acid. It is prepared by neutralizing cit- federallregister/ ric acid with calcium hydroxide or cal- codeloflfederallregulations/ cium carbonate. It occurs as a fine ibrllocations.html. white, odorless powder and usually (c) The ingredient is used as a firm- contains four moles of water per mole ing agent as defined in § 170.3(o)(10) of of calcium citrate. this chapter; formulation aid as defined

510

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00520 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1206

in § 170.3(o)(14) of this chapter; the following current good manufac- sequestrant as defined in § 170.3(o)(26) of turing practice conditions of use: this chapter; stabilizer or thickener as (1) The ingredient is used as a nutri- defined in § 170.3(o)(28) of this chapter; ent supplement as defined in and texturizer as defined in § 170.3(o)(32) § 170.3(o)(20) of this chapter. of this chapter. (2) The ingredient is used in gelatins, (d) The ingredient is used in foods at puddings, and fillings as defined in levels not to exceed current good man- § 170.3(n)(22) of this chapter. ufacturing practices in accordance (d) Prior sanctions for this ingredient with § 184.1(b)(1). Current good manu- different from the uses established in facturing practices result in a max- this section or different from that as imum level, as served, of 1.75 percent set forth in part 181 of this chapter, do for baked goods as defined in not exist or have been waived. § 170.3(n)(1) of this chapter; 0.4 percent for dairy product analogs as defined in [57 FR 10813, Mar. 31, 1992] § 170.3(n)(10) of this chapter; 4.5 percent § 184.1205 Calcium hydroxide. for gelatins and puddings as defined in § 170.3(n)(22) of this chapter; and 0.01 (a) Calcium hydroxide (Ca(OH)2, CAS percent for sugar substitutes as defined Reg. No. 1305–62–0) is also known as in § 170.3(n)(42) of this chapter. slaked lime or calcium hydrate. It is (e) Prior sanctions for this ingredient produced by the hydration of lime. different from the uses established in (b) The ingredient meets the speci- this section do not exist or have been fications of the Food Chemicals Codex, waived. 3d Ed. (1981), p. 52, which is incor- porated by reference. Copies are avail- [47 FR 27808, June 25, 1982] able from the National Academy Press, 2101 Constitution Ave. NW., Wash- § 184.1201 Calcium glycerophosphate. ington, DC 20418, or available for in- (a) Calcium glycerophosphate spection at the National Archives and (C3H7CaO6P, CAS Reg. No. 27214–00–2) is Records Administration (NARA). For a fine, white, odorless, almost taste- information on the availability of this less, slightly hygroscopic powder. It is material at NARA, call 202–741–6030, or prepared by neutralizing glycero- go to: http://www.archives.gov/ phosphoric acid with calcium hydrox- federallregister/ ide or calcium carbonate. The commer- codeloflfederallregulations/ cial product is a mixture of calcium b- ibrllocations.html. , and D-, and L-a-glycerophosphate. (c) In accordance with § 184.1(b)(1), (b) The ingredient meets the speci- the ingredient is used in food with no fications of the ‘‘Food Chemicals limitation other than current good Codex,’’ 3d Ed. (1981), pp. 51–52, which is manufacturing practice. incorporated by reference in accord- (d) Prior sanctions for this ingredient ance with 5 U.S.C. 552(a) and 1 CFR different from the uses established in part 51. Copies may be obtained from this section do not exist or have been the National Academy Press, 2101 Con- waived. stitution Ave. NW., Washington, DC 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(IO3)2·H2O, CAS NARA, call 202–741–6030, or go to: http:// 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 (CaCO3) in (c) In accordance with § 184.1(b)(1), 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.,

511

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00521 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1207 21 CFR Ch. I (4–1–15 Edition)

Washington, DC 20418, or may be exam- flavoring agent or adjuvant as defined ined at the National Archives and in § 170.3(o)(12) of this chapter; a leav- Records Administration (NARA). For ening agent as defined in § 170.3(o)(17) of information on the availability of this this chapter; a nutrient supplement as material at NARA, call 202–741–6030, or defined in § 170.3(o)(20) of this chapter; go to: http://www.archives.gov/ and a stabilizer and thickener as de- federallregister/ fined in § 170.3(o)(28) of this chapter. codeloflfederallregulations/ (2) The ingredient is used in food, ex- ibrllocations.html. cept in infant foods and infant for- (c) The ingredient is used as a dough mulas, at levels not to exceed current strengthener as defined in § 170.3(o)(6) good manufacturing practice. of this chapter. (d) Prior sanctions for this ingredient (d) The ingredient is used in the man- different from the uses established in ufacture of bread in accordance with this section do not exist or have been § 184.1(b)(2) of this chapter in an waived. amount not to exceed 0.0075 percent based on the weight of the flour. [49 FR 35367, Sept. 7, 1984] (e) Prior sanctions for this ingredient different from the uses established in § 184.1210 Calcium oxide. this section do not exist or have been (a) Calcium oxide (CaO, CAS Reg. No. waived. 1305–78–8) is also known as lime, quick [43 FR 11699, Mar. 21, 1978, as amended at 49 lime, burnt lime, or calx. It is produced FR 5611, Feb. 14, 1984] from calcium carbonate, limestone, or oyster shells by calcination at tem- § 184.1207 Calcium lactate. peratures of 1,700–2,450 °F.

(a) Calcium lactate (C6H10CaO6. xH2O, (b) The ingredient meets the speci- where x is any integer up to 5, CAS fications of the Food Chemicals Codex, Reg. No. 814–80–2) is prepared commer- 3d Ed. (1981), p. 55, which is incor- cially by the neutralization of lactic porated by reference. Copies are avail- acid with calcium carbonate or cal- able from the National Academy Press, cium hydroxide. 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. 53, 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 Avenue 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. 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 do not exist or have been the ingredient is used in food with no waived. limitation other than current good manufacturing practice. The affirma- [49 FR 26714, June 29, 1984] tion of this ingredient as generally rec- ognized as safe (GRAS) as a direct § 184.1212 Calcium pantothenate. human food ingredient is based upon (a) Calcium pantothenate the following current good manufac- ((C9H16NO5)2Ca, CAS Reg. No. of the D- turing practice conditions of use: isomer, 137–08–6) is a salt of panto- (1) The ingredient is used as a firm- thenic acid, one of the vitamins of the ing agent as defined in § 170.3(o)(10) of B complex. Only the D-isomer of panto- this chapter; a flavor enhancer as de- thenic acid has vitamin activity, al- fined in § 170.3(o)(11) of this chapter; a though both the D-isomer and the DL-

512

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00522 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1229

racemic mixture of calcium panto- 3d Ed. (1981), p. 60, which is incor- thenate are used in food. Commercial porated by reference. Copies are avail- calcium pantothenate is prepared syn- able from the National Academy Press, thetically from isobutyraldehyde and 2101 Constitution Ave. NW., Wash- formaldehyde via 1,1-dimethyl-2-hy- ington, DC 20418, or available for in- droxy-propionaldehyde and spection at the National Archives and pantolactone. Records Administration (NARA). For (b) Calcium pantothenate meets the information on the availability of this specifications of the Food Chemicals material at NARA, call 202–741–6030, or Codex, 3d Ed. (1981), p. 56, which is in- go to: http://www.archives.gov/ corporated by reference. Copies are federallregister/ available from the National Academy codeloflfederallregulations/ Press, 2101 Constitution Ave. NW., ibrllocations.html. Washington, DC 20418, or available for (c) In accordance with § 184.1(b)(1), inspection at the National Archives the ingredient is used in food with no and Records Administration (NARA). limitation other than current good For information on the availability of manufacturing practice. The affirma- this material at NARA, call 202–741– tion of this ingredient as generally rec- 6030, or 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 an anti- the ingredient is used in food with no microbial agent as defined in limitation other than current good § 170.3(o)(2) 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 baked goods as defined in § 170.3(n)(1) of the following current good manufac- this chapter; cheeses as defined in turing practice conditions of use: § 170.3(n)(5) of this chapter; confections (1) The ingredient is used as a nutri- and frostings as defined in § 170.3(n)(9) ent supplement as defined in of this chapter; gelatins, puddings, and § 170.3(o)(20) of this chapter. fillings as defined in § 170.3(n)(22) of (2) The ingredient is used in foods at this chapter; and jams and jellies as de- levels not to exceed current good man- fined in § 170.3(n)(28) of this chapter. ufacturing practice. Calcium panto- (d) Prior sanctions for this ingredient thenate may be used in infant formula different from the uses established in in 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- [49 FR 13141, Apr. 3, 1984] gated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient § 184.1229 Calcium stearate. different from the uses established in (a) Calcium stearate (Ca(C H COO) , this section do not exist or have been 17 35 2 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 pre- cipitate 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

513

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00523 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1230 21 CFR Ch. I (4–1–15 Edition)

inspection at the National Archives (c) The ingredient is used as an and Records Administration (NARA). anticaking agent as defined in For information on the availability of § 170.3(o)(1) of this chapter, color and this material at NARA, call 202–741– coloring adjunct as defined in 6030, or go to: http://www.archives.gov/ § 170.3(o)(4) of this chapter, dough federallregister/ strengthener as defined in § 170.3(o)(6) codeloflfederallregulations/ of this chapter, drying agent as defined ibrllocations.html. in § 170.3(o)(7) of this chapter, firming (c) In accordance with § 184.1(b)(1), agent as defined in § 170.3(o)(10) of this the ingredient is used in food with no chapter, flour treating agent as defined limitation other than current good in § 170.3(o)(13) of this chapter, formula- manufacturing practice. The affirma- tion aid as defined in § 170.3(o)(14) of tion of this ingredient as generally rec- this chapter, leavening agent as de- ognized as safe (GRAS) as a direct fined in § 170.3(o)(17) of this chapter, nu- human food ingredient is based upon trient supplement as defined in the following current good manufac- § 170.3(o)(20) of this chapter, pH control turing practice conditions of use: agent as defined in § 170.3(o)(23) of this (1) The ingredient is used as a fla- chapter, processing aid as defined in voring agent and adjuvant as defined in § 170.3(o)(24) of this chapter, stabilizer § 170.3(o)(12) of this chapter; a lubricant and thickener as defined in § 170.3(o)(28) and release agent as defined in of this chapter, synergist as defined in § 170.3(o)(18) of this chapter; and a sta- § 170.3(o)(31) of this chapter, and bilizer and thickener as defined in texturizer as defined in § 170.3(o)(32) of § 170.3(o)(28) of this chapter. this chapter. (d) The ingredient is used in food at (2) The ingredient is used in foods 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 [48 FR 52445, Nov. 18, 1983] frostings as defined in § 170.3(n)(9) of this chapter, 0.5 percent for frozen § 184.1230 Calcium sulfate. dairy desserts and mixes as defined in § 170.3(n)(20) of this chapter, 0.4 percent (a) Calcium sulfate (CaSO4, CAS Reg. for gelatins and puddings as defined in No. 7778–18–9 or CaSO4·2H2O, CAS Reg. No. 10101–41–4), also known as plaster of § 170.3(n)(22) of this chapter, 0.5 percent Paris, anhydrite, and gypsum, occurs for grain products and pastas as de- naturally and exists as a fine, white to fined in § 170.3(n)(23) of this chapter, slightly yellow-white odorless powder. 0.35 percent for processed vegetables as The anhydrous form is prepared by defined in § 170.3(n)(36) of this chapter, 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 exam- ined at the National Archives and § 184.1240 Carbon dioxide. Records Administration (NARA). For (a) Carbon dioxide (empirical formula information on the availability of this CO2, CAS Reg. No. 124–38–9) occurs as a material at NARA, call 202–741–6030, or 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

514

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00524 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1250

as a byproduct of the manufacture of (c) In accordance with § 184.1(b)(1), lime during the ‘‘burning’’ of lime- the ingredient is used in food with no stone, from the combustion of carbo- limitation other than current good naceous material, from fermentation manufacturing practice. The affirma- processes, and from gases found in cer- tion of this ingredient as generally rec- tain natural springs and wells. ognized as safe (GRAS) as a direct (b) The ingredient must be of a pu- human food ingredient is based upon rity suitable for its intended use. 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- limitations 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- ognized as safe (GRAS) as a direct (2) The ingredient is used in the fol- human food ingredient is based upon lowing foods at levels not to exceed the following current good manufac- current good manufacturing practice: turing practice conditions of use: dairy product analogs as defined in (1) The ingredient is used as a leav- § 170.3(n)(10) of this chapter; fats and ening agent as defined in § 170.3(o)(17) of oils as defined in § 170.3(n)(12) of this this chapter; a processing aid as de- chapter; and processed fruits and fruit fined in § 170.3(o)(24) of this chapter; juices as defined in § 170.3(n)(35) of this and a propellant, aerating agent, and chapter. Beta-carotene may be used in gas as defined in § 170.3(o)(25) of this infant formula as a source of vitamin A chapter. 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 (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. [48 FR 57270, Dec. 29, 1983, as amended at 73 [52 FR 25211, July 6, 1987] FR 8607, Feb. 14, 2008] § 184.1250 Cellulase enzyme prepara- § 184.1245 Beta-carotene. tion derived from Trichoderma (a) Beta-carotene (CAS Reg. No. 7235– longibrachiatum. 40–7) has the molecular formula C H . 40 56 (a) Cellulase enzyme preparation is It is synthesized by saponification of derived from a nonpathogenic, vitamin A acetate. The resulting alco- nontoxicogenic strain of Trichoderma hol is either reacted to form vitamin A longibrachiatum (formerly T. reesei). The Wittig reagent or oxidized to vitamin A enzyme, cellulase, catalyzes the aldehyde. Vitamin A Wittig reagent and vitamin A aldehyde are reacted to- endohydrolysis of 1,4-beta-glycosidic gether to form beta-carotene. linkages in cellulose. It is obtained (b) The ingredient meets the speci- from the culture filtrate resulting from fications of the Food Chemicals Codex, a pure culture fermentation process. 3d Ed. (1981), p. 73, which is incor- (b) The ingredient meets the general porated by reference. Copies are avail- and additional requirements for en- able from the National Academy Press, zyme preparations in the monograph 2101 Constitution Ave. NW., specifications on enzyme preparations Washingtion, DC 20418, or available for in the ‘‘Food Chemicals Codex,’’ 4th ed. inspection at the National Archives (1996), pp. 129 to 134, which is incor- and Records Administration (NARA). porated by reference in accordance For information on the availability of with 5 U.S.C. 552(a) and 1 CFR part 51. this material at NARA, call 202–741– Copies are available from the National 6030, or go to: http://www.archives.gov/ Academy Press, 2101 Constitution Ave. federallregister/ NW., Box 285, Washington, DC 20055 codeloflfederallregulations/ (Internet http://www.nap.edu), or may ibrllocations.html. be examined at the Center for Food

515

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00525 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1257 21 CFR Ch. I (4–1–15 Edition)

Safety and Applied Nutrition’s Li- NARA, call 202–741–6030, or go to: http:// brary, 5100 Paint Branch Pkwy., Col- www.archives.gov/federallregister/ lege Park, MD 20740, or at the National codeloflfederallregulations/ Archives and Records Administration ibrllocations.html. As determined by (NARA). For information on the avail- analytical methods in the ‘‘Food ability of this material at NARA, call Chemicals Codex,’’ clove oleoresin or 202–741–6030, or go to: http:// other natural extractives (other than www.archives.gov/federallregister/ clove oils) meet the ‘‘Food Chemicals codeloflfederallregulations/ Codex’’ specifications for clove (clove ibrllocations.html. bud) oil and the following modifica- (c) In accordance with § 184.1(b)(1), tions: the ingredient is used in food with no (1) The assay for phenols, as eugenol, limitation other than current good by the ‘‘Food Chemicals Codex’’ test, manufacturing practice. The affirma- 4th ed. (pp. 104–105), or the volatile oils tion of this ingredient as generally rec- content by the ‘‘Food Chemicals ognized as safe (GRAS) as a direct Codex’’ test, 4th ed. (pp. 104–105) should human food ingredient is based upon conform to the representation of the the following current good manufac- vendor; turing practice conditions of use: (2) Optical rotation of the volatile oil (1) The ingredient is used in food as between ¥2° and 0°; an enzyme as defined in § 170.3(o)(9) of (3) of the volatile oil this chapter for the breakdown of cel- between 1.527 and 1.538 at 20 °C; lulose. (4) Specific gravity of the volatile oil (2) The ingredient is used in food at between 1.036 and 1.060; and levels not to exceed current good man- ufacturing practice. (5) Residual solvent free, except those solvents that are GRAS or within tol- [64 FR 28361, May 26, 1999] erance levels as specified in part 173, subpart C, of this chapter. § 184.1257 Clove and its derivatives. (c) Clove and its derivatives are used (a) Cloves are the dried unopened as flavoring agents and adjuvants as flower buds and calyx tubes, harvested defined in § 170.3(0)(12) of this chapter. before the flowers have opened, of the (d) The ingredients are used in food clove tree Eugenia caryophyllata at levels not to exceed good manufac- Thunberg, native to tropical Asia. turing practice in accordance with Their derivatives include essential oils § 184.1(b)(1). (cloves, CAS Reg. No. 8000–34–8; buds; (e) Prior sanctions for these ingredi- leaves, CAS Reg. No. 8015–97–2; stems, ents different from the uses established CAS Reg. No. 8015–98–3; and eugenol, in this section do not exist or have CAS Reg. No. 97–53–0), oleoresins, and been waived. natural extractives obtained from clove buds, leaves, and stems. [44 FR 3964, Jan. 19, 1979, as amended at 47 (b) Clove bud oil, clove leaf oil, clove FR 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, stem oil, and eugenol meet the speci- 1984; 64 FR 1759, Jan. 12, 1999] fications of the ‘‘Food Chemicals Codex,’’ 4th ed. (1996), pp. 104–105, which § 184.1259 Cocoa butter substitute. is incorporated by reference in accord- (a) The common or usual name for ance with 5 U.S.C. 552(a) and 1 CFR the triglyceride 1-palmitoyl-2-oleoyl-3- part 51. Copies are available from the stearin is ‘‘cocoa butter substitute pri- National Academy Press, Box 285, 2101 marily from palm oil.’’ The common or Constitution Ave. NW., Washington, usual name for the triglyceride 1-3- DC 20055 (Internet address http:// distearoyl-2-olein is ‘‘cocoa butter sub- www.nap.edu), or may be examined at stitute primarily from high-oleic saf- the Center for Food Safety and Applied flower or sunflower oil.’’ Nutrition’s Library, Food and Drug Ad- (1) The ingredient 1-palmitoyl-2-ole- ministration, 5100 Paint Branch Pkwy., oyl-3-stearin is manufactured by: College Park, MD 20740, or at the Na- (i) Directed esterification of fully tional Archives and Records Adminis- saturated 1,3-diglycerides (derived from tration (NARA). For information on palm oil) with the anhydride of food- the availability of this material at grade oleic acid in the presence of the

516

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00526 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1259

catalyst trifluoromethane sulfonic acid incorporated by reference), residual (§ 173.395 of this chapter), or fluorine; limit of detection 0.2 part per (ii) By interesterification of partially million F; multiply fluoride result by saturated 1,2,3-triglycerides (derived 2.63 to convert to residual catalyst. from palm oil) with ethyl stearate in Copies of the material incorporated by the presence of a suitable lipase en- reference may be obtained from the zyme preparation that is either gen- AOAC INTERNATIONAL, 481 North erally recognized as safe (GRAS) or has Frederick Ave., suite 500, Gaithersburg, food additive approval for such use. MD 20877, or may be examined at the (2) The ingredient 1-3-distearoyl-2- National Archives and Records Admin- olein is manufactured by istration (NARA). For information on interesterification of partially unsatu- the availability of this material at rated 1,2,3-triglycerides (derived from NARA, call 202–741–6030, or go to: http:// high-oleic safflower or sunflower oil) www.archives.gov/federallregister/ with ethyl stearate or stearic acid in codeloflfederallregulations/ the presence of a suitable lipase en- ibrllocations.html. The ingredient shall zyme preparation that is either GRAS be washed three times in batches with or has food additive approval for such 0.5 percent sodium bicarbonate to re- use. move catalyst residuals in accordance (b) The ingredient meets the fol- with good manufacturing practice. lowing specifications: (7) Residual methanol—5 parts per (1) Over 90 percent triglycerides, not million maximum. more than 7 percent diglycerides, not (8) Residual fatty acid ethyl esters— more than 1 percent monoglycerides, not more than 20 parts per million as and not more than 1 percent free fatty determined by a ‘‘Modification of acids. Japan Institute of Oils and Fats: Anal- (2) Total glycerides—98 percent min- ysis Method of Residual Ethyl Esters of imum. Fatty Acids’’ issued by the Fuji Oil (3) Heavy metals (as lead), not more Co., which is incorporated by reference. than 10 milligrams per kilogram, as de- Copies are available from the Office of termined by the Heavy Metals Test of Food Additive Safety (HFS–200), Center the ‘‘Food Chemicals Codex,’’ 4th ed. for Food Safety and Applied Nutrition, (1996), pp. 760–761, which is incorporated Food and Drug Administration, 5100 by reference in accordance with 5 Paint Branch Pkwy., College Park, MD U.S.C. 552(a) and 1 CFR part 51. Copies 20740, 240–402–1200, or available for in- are available from the National Acad- spection at the National Archives and emy Press, Box 285, 2101 Constitution Records Administration (NARA). For 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 codeloflfederallregulations/ 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. Division of Food and Color Additives, (5) Odor and taste—free from foreign Center for Food Safety and Applied Nu- and rancid odor and taste. trition (HFS–200), Food and Drug Ad- (6) Residual catalyst (‘‘Official Meth- ministration, 5100 Paint Branch Pkwy., ods of Analysis of the Association of College Park, MD 20740, or available for Official Analytical Chemists,’’ 13th Ed. inspection at the National Archives (1980), sections 25.049–25.055, which is and Records Administration (NARA).

517

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00527 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1260 21 CFR Ch. I (4–1–15 Edition)

For information on the availability of ognized as safe (GRAS) as a direct this material at NARA, call 202–741– human food ingredient is based upon 6030, or 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 nutri- ibrllocations.html. ent supplement as defined in (c) In accordance with § 184.1(b)(1), § 170.3(o)(20) of this chapter and as a the ingredient is used in the following synergist as defined in § 170.3(o)(31) of food categories at levels not to exceed this chapter. current good manufacturing practice: (2) The ingredient is used in food at Confections and frostings as defined in levels not to exceed current good man- § 170.3(n)(9) of this chapter; coatings of ufacturing practice. Copper gluconate soft candy as defined in § 170.3(n)(38) of may be used in infant formula in ac- this chapter; and sweet sauces and top- cordance with section 412(g) of the Fed- pings as defined in § 170.3(n)(43) of this eral Food, Drug, and Cosmetic Act (the chapter; except that the ingredient Act) or with regulations promulgated may not be used in a standardized food under section 412(a)(2) of the Act. unless permitted by the standard of (d) Prior sanctions for this ingredient identity. different from the uses established in (d) The ingredient is used in food in this section do not exist or have been accordance with § 184.1(b)(1) at levels waived. not to exceed good manufacturing [49 FR 24119, June 12, 1984] practice. § 184.1261 Copper sulfate. [43 FR 54239, Nov. 11, 1978, as amended at 47 FR 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, (a) Copper sulfate (cupric sulfate, 1984; 49 FR 22799, June 1, 1984; 52 FR 47920, CuSO4·5 H2O, CAS Reg. No. 7758–99–8) Dec. 17, 1987; 52 FR 48905, Dec. 28, 1987; 61 FR usually is used in the pentahydrate 36290, July 10, 1996; 64 FR 1760, Jan. 12, 1999; form. This form occurs as large, deep 78 FR 14666, Mar. 7, 2013] blue or ultramarine, triclinic crystals; as blue granules, or as a light blue pow- § 184.1260 Copper gluconate. der. The ingredient is prepared by the (a) Copper gluconate (cupric gluco- reaction of sulfuric acid with cupric nate (CH2OH(CHOH)4COO)2Cu, CAS oxide or with copper metal. Reg. No. 527–09–3) is a substance that (b) The ingredient must be of a pu- occurs as light blue to bluish-green, rity suitable for its intended use. odorless crystals, or as a fine, light (c) In accordance with § 184.1(b)(1), blue powder. It is prepared by the reac- the ingredient is used in food with no tion of gluconic acid solutions with cu- limitation other than current good pric oxide or basic cupric carbonate. manufacturing practice. The affirma- (b) The ingredient meets the speci- tion of this ingredient as generally rec- fications of the Food Chemicals Codex, ognized as safe (GRAS) as a direct 3d Ed. (1981), p. 90, which is incor- human food ingredient is based upon porated by reference. Copies are avail- the following current good manufac- able from the National Academy Press, turing practice conditions of use: 2101 Constitution Ave. NW., Wash- (1) The ingredient is used as a nutri- ington, DC. 20418, or available for in- ent supplement as defined in spection at the National Archives and § 170.3(o)(20) of this chapter and as a Records Administration (NARA). For processing aid as defined in § 170.3(o)(24) information on the availability of this of this chapter. material at NARA, call 202–741–6030, or (2) The ingredient is used in food at go to: http://www.archives.gov/ levels not to exceed current good man- federallregister/ ufacturing practice. Copper sulfate codeloflfederallregulations/ may be used in infant formula in ac- ibrllocations.html. cordance with section 412(g) of the Fed- (c) In accordance with § 184.1(b)(1), eral Food, Drug, and Cosmetic Act (the the ingredient is used in food with no Act) or with regulations promulgated limitation other than current good under section 412(a)(2) of the Act. manufacturing practice. The affirma- (d) Prior sanctions for this ingredient tion of this ingredient as generally rec- different from the uses established in

518

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00528 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1272

this section do not exist or have been within the following specific limita- waived. tions: [49 FR 24119, June 12, 1984, as amended at 73 Cat- Maximum treatment FR 8607, Feb. 14, 2008; 76 FR 59249, Sept. 26, egory level in food Functional use 2011] of food Table 0.01 percent ...... Source of dietary iodine. § 184.1262 Corn silk and corn silk ex- salt. tract. (a) Corn silk is the fresh styles and (d) Prior sanctions for this ingredient stigmas of Zea mays L. collected when different from the uses established in the corn is in milk. The filaments are this section do not exist or have been extracted with dilute ethanol to waived. produce corn silk extract. The extract [49 FR 24119, June 12, 1984, as amended at 73 may be concentrated at a temperature FR 8607, Feb. 14, 2008] not exceeding 60 °C. (b) The ingredient must be of a pu- § 184.1271 L-Cysteine. rity suitable for its intended use. (a) L-Cysteine is the chemical L-2- (c) In accordance with § 184.1(b)(2), amino-3-mercaptopropanoic acid the ingredients are used in food only (C3H7O2NS). within the following specific limita- (b) The ingredient meets the appro- tions: priate part of the specification set forth in the ‘‘Food Chemicals Codex,’’ Maximum level of 3d Ed. (1981), pp. 92–93, which is incor- Category of food use in Functional use porated by reference. Copies may be food (as served) 1 obtained from the National Academy Press, 2101 Constitution Ave. NW., Baked goods and bak- 30 Flavoring agent, Washington, DC 20418, or may be exam- ing mixes, § 170.3(o)(12) of this § 170.3(n)(1) of this chapter. ined at the National Archives and chapter. Records Administration (NARA). For Nonalcoholic bev- 20 Do. information on the availability of this erages, § 170.3(n)(3) material at NARA, call 202–741–6030, or of this chapter. Frozen dairy desserts, 10 Do. go to: http://www.archives.gov/ § 170.3(n)(20) of this federallregister/ chapter. codeloflfederallregulations/ Soft candy, 20 Do. ibrllocations.html. § 170.3(n)(38) of this chapter. (c) The ingredient is used to supply All other food cat- 4 Do. up to 0.009 part of total L-cysteine per egories. 100 parts of flour in dough as a dough 1 Parts per million. strengthener as defined in § 170.3(o)(6) of this chapter in yeast-leavened baked (d) Prior sanctions for this ingredient goods and baking mixes as defined in different from the uses established in § 170.3(n)(1) of this chapter. this section do not exist or have been (d) This regulation is issued prior to waived. a general evaluation of use of this in- [47 FR 29953, July 9, 1982, as amended at 73 gredient in order to affirm as GRAS FR 8607, Feb. 14, 2008] the specific use named.

§ 184.1265 Cuprous iodide. [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984] (a) Cuprous iodide (copper (I) iodide, CuI, CAS Reg. No. 7681–65–4) is a pure § 184.1272 L-Cysteine white crystalline powder. It is prepared monohydrochloride. 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

519

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00529 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1277 21 CFR Ch. I (4–1–15 Edition)

Codex,’’ 3d Ed. (1981), pp. 92–93, which is human food ingredient is based upon incorporated by reference. Copies may the following current good manufac- be obtained from the National Acad- turing practice conditions of use: emy Press, 2101 Constitution Ave. NW., (1) The ingredient is used as a formu- Washington, DC 20418, or may be exam- lation aid as defined in § 170.3(o)(14) of ined at the National Archives and this chapter; as a processing aid as de- Records Administration (NARA). For fined in § 170.3(o)(24) of this chapter; as information on the availability of this a stabilizer and thickener as defined in material at NARA, call 202–741–6030, or § 170.3(o)(28) of this chapter; and as a go to: http://www.archives.gov/ surface-finishing agent as defined in federallregister/ § 170.3(o)(30) of this chapter. codeloflfederallregulations/ (2) The ingredient is used in food at ibrllocations.html. levels not to exceed current good man- (c) The ingredient is used to supply ufacturing practice. up to 0.009 part of total L-cysteine per (d) Prior sanctions for this ingredient 100 parts of flour in dough as a dough different from the uses established in strengthener as defined in § 170.3(o)(6) this section do not exist or have been of this chapter in yeast-leavened baked waived. goods and baking mixes as defined in § 170.3(n)(1) of this chapter. [48 FR 51909, Nov. 15, 1983] (d) This regulation is issued prior to a general evaluation of use of this in- § 184.1278 Diacetyl.

gredient in order to affirm as GRAS (a) Diacetyl (C4H6O2, CAS Reg. No. the specific use named. 431–03–8) is a clear yellow to yellowish [42 FR 14653, Mar. 15, 1977, as amended at 49 green liquid with a strong pungent FR 5612, Feb. 14, 1984] odor. It is also known as 2,3- butanedione and is chemically syn- § 184.1277 Dextrin. thesized from methyl ethyl ketone. It is miscible in water, glycerin, alcohol, (a) Dextrin ((C6H10O5)n·H2O, CAS Reg. No. 9004–53–9) is an incompletely and ether, and in very dilute water so- hydrolyzed starch. It is prepared by dry lution, it has a typical buttery odor heating corn, waxy maize, waxy milo, and flavor. potato, arrowroot, wheat, rice, tapioca, (b) The ingredient meets the speci- or sago starches, or by dry heating the fications of the Food Chemicals Codex, starches after: (1) Treatment with safe 3d Ed. (1981), p. 368, which is incor- and suitable alkalis, acids, or pH con- porated by reference. Copies are avail- trol agents and (2) drying the acid or able from the National Academy Press, alkali treated starch. 2101 Constitution Ave. NW., Wash- (b) The ingredient meets the speci- ington, DC 20418, or available for in- fication of the Food Chemicals Codex, spection at the National Archives and 3d Ed. (1981), p. 96, 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 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.

520

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00530 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1293

(2) The ingredient is used in food at butterfat or milkfat; and steam-ren- levels not to exceed current good man- dered chicken fat, respectively, with ufacturing practice. enzymes that are generally recognized (d) Prior sanctions for this ingredient as safe (GRAS). Enzyme-modified milk different from the uses established in powder may be prepared with GRAS this section do not exist or have been enzymes from reconstituted milk pow- waived. der, whole milk, condensed or con- centrated whole milk, evaporated [48 FR 51907, Nov. 15, 1983] milk, or milk powder. The lipolysis is § 184.1282 Dill and its derivatives. maintained at a temperature that is optimal for the action of the enzyme (a) Dill (American or European) is until appropriate acid development is the herb and seeds from Anethum attained. The enzymes are then inac- graveolens L., and dill (Indian) is the tivated. The resulting product is con- herb and seeds from Anethum sowa, centrated or dried. D.C. Its derivatives include essential (b) The ingredients must be of a pu- oils, oleoresins, and natural extractives rity suitable for their intended use. obtained from these sources of dill. (c) In accordance with § 184.1(b)(1), (b) Dill oils meet the description and the ingredients are used in food with specifications of the ‘‘Food Chemicals no limitation other than current good Codex,’’ 4th ed. (1996), pp. 122–123, which manufacturing practice. The affirma- is incorporated by reference in accord- tion of these ingredients as generally ance with 5 U.S.C. 552(a) and 1 CFR recognized as safe (GRAS) as direct part 51. Copies are available from the human food ingredients is based upon National Academy Press, Box 285, 2101 the following current good manufac- Constitution Ave. NW., Washington, turing practice conditions of use: DC 20055 (Internet address http:// (1) The ingredients are used as fla- www.nap.edu), or may be examined at voring agents and adjuvants as defined the Center for Food Safety and Applied in § 170.3(o)(12) of this chapter. Nutrition’s Library, Food and Drug Ad- (2) The ingredients are used in food ministration, 5100 Paint Branch Pkwy., at levels not to exceed current good College Park, MD 20740, or at the Na- manufacturing practice. tional Archives and Records Adminis- (d) Prior sanctions for these ingredi- tration (NARA). For information on ents different from the uses established the availability of this material at in this section do not exist or have NARA, call 202–741–6030, or go to: http:// been waived. www.archives.gov/federallregister/ [52 FR 25976, July 10, 1987, as amended at 73 codeloflfederallregulations/ FR 8607, Feb. 14, 2008] ibrllocations.html. (c) Dill and its derivatives are used as § 184.1293 Ethyl alcohol. flavoring agents and adjuvants as de- (a) Ethyl alcohol (ethanol) is the fined in § 170.3(o)(12) of this chapter. chemical C2H5OH. (d) The ingredients are used in food (b) The ingredient meets the speci- at levels not to exceed good manufac- fications of the ‘‘Food Chemicals turing practice. Codex,’’ 4th ed. (1996), p. 136, which is (e) [Reserved] incorporated by reference in accord- (f) Prior sanctions for these ingredi- ance with 5 U.S.C. 552(a) and 1 CFR ents different from the uses established part 51. Copies are available from the in this section do not exist or have National Academy Press, Box 285, 2101 been waived. Constitution Ave. NW., Washington, [42 FR 14653, Mar. 15, 1977, as amended at 42 DC 20055 (Internet address http:// FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, www.nap.edu), or may be examined at 1984; 64 FR 1760, Jan. 12, 1999] the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Ad- § 184.1287 Enzyme-modified fats. ministration, 5100 Paint Branch Pkwy., (a) Enzyme-modified refined beef fat, College Park, MD 20740, or at the Na- enzyme-modified butterfat, and en- tional Archives and Records Adminis- zyme-modified steam-rendered chicken tration (NARA). For information on fat are prepared from refined beef fat; the availability of this material at

521

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00531 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1295 21 CFR Ch. I (4–1–15 Edition)

NARA, call 202–741–6030, or go to: http:// ter; 0.02 percent in frozen dairy des- www.archives.gov/federallregister/ serts as defined in § 170.3(n)(20) of this codeloflfederallregulations/ chapter; 0.03 percent in gelatins, pud- ibrllocations.html. dings, and fillings as defined in (c) The ingredient is used as an anti- § 170.3(n)(22) of this chapter; and 0.01 microbial agent as defined in percent in all other food categories. § 170.3(o)(2) of this chapter on pizza (e) Prior sanctions for ethyl formate crusts prior to final baking at levels different from the uses established in not to exceed 2.0 percent by product this section do not exist or have been weight. waived. (d) This regulation is issued prior to general evaluation of use of this ingre- [45 FR 22915, Apr. 4, 1980, as amended at 49 dient in order to affirm as GRAS the FR 5612, Feb. 14, 1984] specific use named. § 184.1296 Ferric ammonium citrate. [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984; 64 FR 1760, Jan. 12, (a) Ferric ammonium citrate (iron 1999] (III) ammonium citrate) is prepared by the reaction of ferric hydroxide with § 184.1295 Ethyl formate. citric acid, followed by treatment with (a) Ethyl formate (C3H6O2, CAS Reg. ammonium hydroxide, evaporating, No. 109–94–4) is also referred to as ethyl and drying. The resulting product oc- methanoate. It is an ester of formic curs in two forms depending on the acid and is prepared by esterification stoichiometry of the initial reactants. of formic acid with ethyl alcohol or by (1) Ferric ammonium citrate (iron distillation of ethyl acetate and formic (III) ammonium citrate, CAS Reg. No. acid in the presence of concentrated 1332–98–5) is a complex salt of undeter- sulfuric acid. Ethyl formate occurs mined structure composed of 16.5 to naturally in some plant oils, fruits, and 18.5 percent iron, approximately 9 per- juices but does not occur naturally in cent ammonia, and 65 percent citric the animal kingdom. acid and occurs as reddish brown or (b) The ingredient meets the speci- garnet red scales or granules or as a fications of the ‘‘Food Chemicals brownish-yellowish powder. 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- ined at the National Archives and percent iron, approximately 7.5 percent Records Administration (NARA). For ammonia, and 75 percent citric acid information on the availability of this and occurs as thin transparent green material at NARA, call 202–741–6030, or scales, as granules, as a powder, or as go to: http://www.archives.gov/ transparent green crystals. federallregister/ (b) The ingredients meet the speci- codeloflfederallregulations/ fications of the Food Chemicals Codex, ibrllocations.html. 3d Ed. (1981), pp. 116–117 (Ferric ammo- (c) The ingredient is used as a fla- nium citrate, brown) and p. 117 (Ferric voring agent and adjuvant as defined in ammonium citrate, green), which is in- § 170.3(o)(12) of this chapter. corporated by reference. Copies are (d) The ingredient is used in food at available from the National Academy levels not to exceed good manufac- Press, 2101 Constitution Ave. NW., turing practice in accordance with Washington, DC 20418, or available for § 184.1(b)(1). Current good manufac- inspection at the National Archives turing practice results in a maximum and Records Administration (NARA). level, as served, of 0.05 percent in baked For information on the availability of goods as defined in § 170.3(n)(1) of this this material at NARA, call 202–741– chapter; 0.04 percent in chewing gum as 6030, or go to: http://www.archives.gov/ defined in § 170.3(n)(6), hard candy as federallregister/ defined in § 170.3(n)(25), and soft candy codeloflfederallregulations/ as defined in § 170.3(n)(38) of this chap- ibrllocations.html.

522

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00532 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1301

(c) In accordance with § 184.1(b)(1), manufacturing practice. The ingre- the ingredients are used in food as nu- dient may also be used in infant for- trient supplements as defined in mula in accordance with section 412(g) § 170.3(o)(20) of this chapter, with no of the Federal Food, Drug, and Cos- limitation other than current good metic Act (the act) (21 U.S.C. 350a(g)) manufacturing practice. The ingredi- or with regulations promulgated under ents may also be used in infant formula section 412(a)(2) of the act (21 U.S.C. in accordance with section 412(g) of the 350a(a)(2)). Federal Food, Drug, and Cosmetic Act (d) Prior sanctions for this ingredient (the act) (21 U.S.C. 350a(g)) or with reg- different from the uses established in ulations promulgated under section this section do not exist or have been 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). waived. (d) Prior sanctions for these ingredi- [53 FR 16865, May 12, 1988, as amended at 73 ents different from the uses established FR 8607, Feb. 14, 2008] in this section do not exist or have been waived. § 184.1301 Ferric phosphate. [53 FR 16864, May 12, 1988] (a) Ferric phosphate (ferric orthophosphate, iron (III) phosphate, § 184.1297 Ferric chloride. FePO4·xH2O, CAS Reg. No. 10045–86–0) is (a) Ferric chloride (iron (III) chlo- an odorless, yellowish-white to buff- ride, FeC13, CAS Reg. No. 7705–08–0) colored powder and contains from one may be prepared from iron and chlorine to four molecules of water of hydra- or from ferric oxide and hydrogen chlo- tion. It is prepared by reaction of so- ride. The pure material occurs as dium phosphate with ferric chloride or hydroscopic, hexagonal, dark crystals. ferric citrate. Ferric chloride hexahydrate (iron (III) (b) The ingredient meets the speci- chloride hexahydrate, FeC13. 6H20, CAS fications of the Food Chemicals Codex, Reg. No. 10025–77–1) is readily formed 3d Ed. (1981), pp. 118–120, which is incor- when ferric chloride is exposed to mois- porated by reference. Copies are avail- ture. 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) 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 FR 8607, Feb. 14, 2008] ent supplement as defined in § 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- C H FeO , CAS Reg. No. 2338–05–8) is 6 5 7 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]

523

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00533 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1304 21 CFR Ch. I (4–1–15 Edition)

§ 184.1304 Ferric pyrophosphate. (d) Prior sanctions for this ingredient different from the uses established in (a) Ferric pyrophosphate (iron (III) this section do not exist or have been pyrophosphate, Fe (P ) ·xH O, CAS 4 207 3 2 waived. Reg. No. 10058–44–3) is a tan or yel- lowish white colorless powder. It is pre- [53 FR 16865, May 12, 1988, as amended at 73 pared by reacting sodium FR 8607, Feb. 14, 2008] pyrophosphate with ferric citrate. (b) The ingredient meets the speci- § 184.1307a Ferrous ascorbate. fications of the Food Chemicals Codex, (a) Ferrous ascorbate (CAS Reg. No. 3d Ed. (1981), p. 120, which is incor- 24808–52–4) is a reaction product of fer- porated by reference. Copies are avail- rous hydroxide and ascorbic acid. It is able from the National Academy Press, a blue-violet product containing 16 per- 2101 Constitution Ave. NW., Wash- cent iron. ington, DC 20418, or available for in- (b) The ingredient must be of a pu- spection at the National Archives and rity suitable for its intended use. Records Administration (NARA). For (c) In accordance with § 184.1(b)(1), information on the availability of this the ingredient is used in food as a nu- material at NARA, call 202–741–6030, or trient supplement as defined in go to: http://www.archives.gov/ § 170.3(o)(20) of this chapter, with no federallregister/ limitation other than current good codeloflfederallregulations/ manufacturing practice. The ingre- ibrllocations.html. dient may also be used in infant for- (c) In accordance with § 184.1(b)(1), mula in accordance with section 412(g) the ingredient is used in food as a nu- of the Federal Food, Drug, and Cos- trient supplement as defined in metic Act (the act) (21 U.S.C. 350a(g)) § 170.3(o)(20) of this chapter, with no or with regulations promulgated under limitation other than current good section 412(a)(2) of the act (21 U.S.C. manufacturing practice. The ingre- 350a(a)(2)). dient may also be used in infant for- (d) Prior sanctions for this ingredient mula in accordance with section 412(g) different from the uses established in of the Federal Food, Drug, and Cos- this section do not exist or have been metic Act (the act) (21 U.S.C. 350a(g)) waived. or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. [53 FR 16865, May 12, 1988, as amended at 69 350a(a)(2)). FR 24512, May 4, 2004; 73 FR 8607, Feb. 14, 2008] (d) Prior sanctions for this ingredient different from the uses established in § 184.1307b Ferrous carbonate. this section do not exist or have been waived. (a) Ferrous carbonate (iron (II) car- bonate, FeCO3, CAS Reg. No. 563–71–3) [53 FR 16865, May 12, 1988; 53 FR 20939, June is an odorless, white solid prepared by 7, 1988] treating solutions of iron (II) salts with alkali carbonate salts. § 184.1307 Ferric sulfate. (b) The ingredient must be of a pu- (a) Ferric sulfate (iron (III) sulfate, rity suitable for its intended use. Fe2(SO4)3 CAS Reg. No. 10028–22–5) is a (c) In accordance with § 184.1(b)(1), yellow substance that may be prepared the ingredient is used in food as a nu- by oxidizing iron (II) sulfate or by trient supplement as defined in treating ferric oxide or ferric hydrox- § 170.3(o)(20) of this chapter, with no ide with sulfuric acid. limitation other than current good (b) The ingredient must be of a pu- manufacturing practice. The ingre- rity suitable for its intended use. dient may also be used in infant for- (c) In accordance with § 184.1(b)(1), mula in accordance with section 412(g) the ingredient is used in food as a fla- of the Federal Foods, Drug, and Cos- voring agent as defined in § 170.3(o)(12) metic Act (the act) (21 U.S.C. 350a(g)) of this chapter, with no limitation or with regulations promulgated under other than current good manufacturing section 412(a)(2) of the act (21 U.S.C. practice. 350a(a)(2)).

524

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00534 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1308

(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) the waived. ingredient is used in food as a nutrient [53 FR 16865, May 12, 1988, as amended at 73 supplement as defined in § 170.3(o)(20) of FR 8607, Feb. 14, 2008] this chapter, with no limitation other than current good manufacturing prac- § 184.1307c Ferrous citrate. tice. The ingredient may also be used (a) Ferrous citrate (iron (II) citrate, in infant formula in accordance with section 412(g) of the Federal Food, (C6H6FeO7), CAS Reg. No. 23383–11–1) is a slightly colored powder or white Drug, and Cosmetic Act (the act) (21 crystals. It is prepared from the reac- U.S.C. 350a(g)), or with regulations pro- tion of sodium citrate with ferrous sul- mulgated under section 412(a)(2) of the fate or by direct action of citric acid on act (21 U.S.C. 350a(a)(2)). iron filings. (d) Prior sanctions for this ingredient (b) The ingredient must be of a pu- different from the uses established in rity suitable for its intended use. 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 [53 FR 16866, May 12, 1988] supplement as defined in § 170.3(o)(20) of this chapter, with no limitation other § 184.1308 Ferrous gluconate. than current good manufacturing prac- (a) Ferrous gluconate (iron (II) gluco- tice. The ingredient may also be used nate dihydrate, C12H22FeO14·2H2O, CAS in infant formula in accordance with Reg. No. 6047-12-7) is a fine yellowish- section 412(g) of the Federal Food, gray or pale greenish-yellow powder or Drug, and Cosmetic Act (the act) (21 granules. It is prepared by reacting hot U.S.C. 350a(g)) or with regulations pro- solutions of barium or calcium gluco- mulgated under section 412(a)(2) of the nate with ferrous sulfate or by heating act (21 U.S.C. 350a(a)(2)). freshly prepared ferrous carbonate with (d) Prior sanctions for this ingredient gluconic acid in . different from the uses established in (b) The ingredient meets the speci- this section do not exist or have been fications of the Food Chemcials Codex, waived. 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, 2101 Constitution Avenue NW., Wash- § 184.1307d Ferrous fumarate. 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)).

525

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00535 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1311 21 CFR Ch. I (4–1–15 Edition)

(d) Prior sanctions for this ingredient § 184.1315 Ferrous sulfate. different from the uses established in (a) Ferrous sulfate heptahydrate this section do not exist or have been (iron (II) sulfate heptahydrate, waived. FeSO4·7H2O, CAS Reg. No. 7782–63–0) is [53 FR 16866, May 12, 1988; 53 FR 20939, June prepared by the action of sulfuric acid 7, 1988] on iron. It occurs as pale, bluish-green crystals or granules. Progressive heat- § 184.1311 Ferrous lactate. ing of ferrous sulfate heptahydrate pro- (a) Ferrous lactate (iron (II) lactate, duces ferrous sulfate (dried). Ferrous sulfate (dried) consists primarily of fer- C6H10FeO6, CAS Reg. No. 5905–52–2) in the trihydrate form is a greenish-white rous sulfate monohydrate (CAS Reg. powder or crystalline mass. It is pre- No. 17375–41–6) with varying amounts of pared by reacting calcium lactate or ferrous sulfate tetrahydrate (CAS Reg. sodium lactate with ferrous sulfate, di- No. 20908–72–9) and occurs as a grayish- white to buff-colored powder. rect reaction of lactic acid with iron (b) The ingredients meet the speci- filings, reaction of ferrous chloride fications of the Food Chemicals Codex, with sodium lactate, or reaction of fer- 3d Ed. (1981), p. 123 (Ferrous sulfate rous sulfate with ammonium lactate. heptahydrate) and p. 124 (ferrous sul- (b) The ingredient meets the speci- fate, dried), which is incorporated by fications of the Food Chemicals Codex, reference. Copies are available from 4th ed. (1996), pp. 154 to 155, which is in- the National Academy Press, 2101 Con- corporated by reference in accordance stitution Ave., NW., Washington, DC with 5 U.S.C. 552(a) and 1 CFR part 51. 20418, or available for inspection at the Copies are available from the National National Archives and Records Admin- Academy Press, 2101 Constitution Ave. istration (NARA). For information on NW., Washington, DC 20418, or may be the availability of this material at examined at the Center for Food Safety NARA, call 202–741–6030, or go to: http:// and Applied Nutrition’s library, 5100 www.archives.gov/federallregister/ Paint Branch Pkwy., College Park, MD codeloflfederallregulations/ 20740, or 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 ingredients are used in food as nu- material at NARA, call 202–741–6030, or trient supplements as defined in go to: http://www.archives.gov/ § 170.3(o)(20) of this chapter and as a federallregister/ processing aid as defined in § 170.3(o)(24) codeloflfederallregulations/ of this chapter, with no limitation ibrllocations.html. other than current good manufacturing (c) In accordance with § 184.1(b)(1), practice. The ingredients may also be the ingredient is used in food as a nu- used in infant formula in accordance trient supplement as defined in with section 412(g) of the Federal Food, § 170.3(o)(20) of this chapter and as a Drug, and Cosmetic Act (the act) (21 color fixative for ripe olives, with no U.S.C. 350a(g)) or with regulations pro- other limitation other than current mulgated under section 412(a)(2) of the good manufacturing practice. The in- act (21 U.S.C. 350a(a)(2)). gredient may also be used in infant for- (d) Prior sanctions for these ingredi- mula in accordance with section 412(g) ents different from the uses established of the Federal Food, Drug, and Cos- in this section do not exist or have metic Act (the act) (21 U.S.C. 350a(g)) been waived. or with regulations promulgated under [53 FR 16866, May 12, 1988] section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). § 184.1316 Ficin. (d) Prior sanctions for this ingredient (a) Ficin (CAS Reg. No. 9001–33–6) is different from the uses established in an enzyme preparation obtained from this section do not exist or have been the latex of species of the genus Ficus, waived. which include a variety of tropical fig [53 FR 16866, May 12, 1988, as amended at 61 trees. It is a white to off-white powder. FR 40319, Aug. 2, 1996] Its characterizing enzyme activity is

526

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00536 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1318

that of a peptide hydrolase (EC NARA, call 202–741–6030, or go to: http:// 3.4.22.3). www.archives.gov/federallregister/ (b) The ingredient meets the general codeloflfederallregulations/ requirements and additional require- ibrllocations.html. ments for enzyme preparations in the (c) Garlic and its derivatives are used Food Chemicals Codex, 3d ed. (1981), p. as flavoring agents and adjuvants as 110, which is incorporated by reference defined in § 170.3(o)(12) of this chapter. in accordance with 5 U.S.C. 552(a) and 1 (d) The ingredients are used in food CFR part 51. Copies are available from at levels not to exceed good manufac- the National Academy Press, 2101 Con- turing practice. stitution Ave., NW., Washington, DC (e) [Reserved] 20418, or may be examined at the Office (f) Prior sanctions for this ingredient of Food Additive Safety (HFS–200), different from the uses established in Center for Food Safety and Applied Nu- this section do not exist or have been trition, Food and Drug Administration, waived. 5100 Paint Branch Pkwy., College Park, [42 FR 14653, Mar. 15, 1977, as amended at 42 MD 20740, 240–402–1200, and at the Na- FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, tional Archives and Records Adminis- 1984] tration (NARA). For information on the availability of this material at § 184.1318 Glucono delta-lactone. NARA, call 202–741–6030, or go to: http:// (a) Glucono delta-lactone (C6H10O6, www.archives.gov/federallregister/ CAS Reg. No. 90–80–2), also called D- codeloflfederallregulations/ gluconic acid delta-lactone or D- ibrllocations.html. glucono-1,5-lactone, is the cyclic 1,5- (c) In accordance with § 184.1(b)(1), intramolecular ester of D-gluconic the ingredient is used in food with no acid. It is prepared by direct crys- limitation other than current good tallization from the aqueous solution manufacturing practice. The affirma- of gluconic acid. Gluconic acid may be tion of this ingredient as GRAS as a di- produced by the oxidation of D-glucose rect food ingredient is based upon the with bromine water, by the oxidation following current good manufacturing of D-glucose by microorganisms that practice conditions of use: are nonpathogenic and nontoxicogenic (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 avail- [60 FR 32910, June 26, 1995, as amended at 78 able from the National Academy Press, FR 14666, Mar. 7, 2013] 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- § 184.1317 Garlic and its derivatives. spection 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:

527

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00537 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1321 21 CFR Ch. I (4–1–15 Edition)

(1) The ingredient is used as a curing § 184.1322 Wheat gluten. and pickling agent as defined in (a) Wheat gluten (CAS Reg. No. 8002– § 170.3(o)(5) of this chapter, leavening 80–0) is the principal protein compo- agent as defined in § 170.3(o)(17) of this nent of wheat and consists mainly of chapter; pH control agent as defined in gliadin and glutenin. Wheat gluten is § 170.3(o)(23) of this chapter; and obtained by hydrating wheat flour and sequestrant as defined in § 170.3(o)(26) of mechanically working the sticky mass this chapter. to separate the wheat gluten from the (2) The ingredient is used at levels starch and other flour components. not to exceed current good manufac- Vital gluten is dried gluten that has re- turing practice. tained its elastic properties. (d) Prior sanctions for this ingredient (b) The ingredient must be of a pu- different from the uses established in rity suitable for its intended use. 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 [51 FR 33896, Sept. 24, 1986] limitation other than current good manufacturing practice. The affirma- § 184.1321 Corn gluten. tion of this ingredient as generally rec- ognized as safe (GRAS) as a direct (a) Corn gluten (CAS Reg. No. 66071– human food ingredient is based upon 96–3), also known as corn gluten meal, the following current good manufac- is the principal protein component of turing practice conditions of use: corn endosperm. It consists mainly of (1) The ingredient is used as a dough zein and glutelin. Corn gluten is a by- strengthener as defined in § 170.3(o)(6) product of the wet milling of corn for of this chapter; a formulation aid as starch. The gluten fraction is washed defined in § 170.3(o)(14) of this chapter; to remove residual water soluble pro- a nutrient supplement as defined in teins. Corn gluten is also produced as a § 170.3(o)(20) of this chapter; a proc- byproduct during the conversion of the essing aid as defined in § 170.3(o)(24) of starch in whole or various fractions of this chapter; a stabilizer and thickener dry milled corn to corn syrups. as defined in § 170.3(o)(28) of this chap- (b) The ingredient must be of a pu- ter; a surface-finishing agent as defined rity suitable for its intended use. in § 170.3(o)(30) of this chapter; and a (c) In accordance with § 184.1(b)(1), texturizing agent as defined in the ingredient is used in food with no § 170.3(o)(32) of this chapter. limitation other than current good (2) The ingredient is used in food at manufacturing practice. The affirma- levels not to exceed current good man- tion of this ingredient as generally rec- ufacturing practice. ognized as safe (GRAS) as a direct (d) Prior sanctions for this ingredient human food ingredient is based upon different from the uses established in the following current good manufac- this section do not exist or have been turing practice conditions of use: waived. (1) The ingredient is used as a nutri- [50 FR 8998, Mar. 6, 1985, as amended at 73 FR ent supplement as defined in 8607, Feb. 14, 2008] § 170.3(o)(20) of this chapter and a texturizer as defined in § 170.3(o)(32) of § 184.1323 Glyceryl monooleate. this chapter. (a) Glyceryl monooleate is prepared (2) The ingredient is used in food at by esterification of commerical oleic levels not to exceed current good man- acid that is derived either from edible ufacturing practice. sources or from tall oil fatty acids (d) Prior sanctions for this ingredient meeting the requirements of § 172.862 of different from the uses established in this chapter. It contains glyceryl this section do not exist or have been monooleate (C21H40O4, CAS Reg. No. waived. 25496–72–4) and glyceryl esters of fatty 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.

528

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00538 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1329

(c) In accordance with § 184.1(b)(1), this section do not not exist or have the ingredient is used in food with no been waived. 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- ognized as safe (GRAS) as a direct § 184.1328 Glyceryl behenate. 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 fla- rated C22 fatty acid). The mixture con- voring agent and adjuvant as defined in tains predominately glyceryl § 170.3(o)(12) of this chapter and as a dibehenate. solvent and vehicle as defined in (b) The ingredient meets the fol- § 170.3(o)(27) of this chapter. lowing specifications: (2) The ingredient is used in the fol- (1) 10 to 20 percent monoglyceride, 47 lowing foods at levels not to exceed to 59 percent diglyceride, 26 to 38 per- current good manufacturing practice: cent triglyceride, and not more than baked goods and baking mixes as de- 2.5 percent free fatty acids. fined in § 170.3(n)(1) of this chapter; (2) Behenic acid. Between 80 and 90 nonalcoholic beverages and beverage percent of the total fatty acid content. bases as defined in § 170.3(n)(3) of this (3) Acid value. Not more than 4. chapter; chewing gum as defined in (4) Saponification value. Between 145 § 170.3(n)(6) of this chapter; and meat and 165. products as defined in § 170.3(n)(29) of (5) Iodine number. Not more than 3. this chapter. (6) Heavy metals (as Pb). Not more (d) Prior sanctions for this ingredient than 10 parts per million. different from the use established in (c) In accordance with § 184.1(b)(1) of this section do not exist or have been this chapter, the ingredient is used in waived. food with no limitation other than cur- rent good manufacturing practice. The [54 FR 7403 Feb. 21, 1989, as amended at 73 FR affirmation of this ingredient is gen- 8607, Feb. 14, 2008] erally recognized as safe (GRAS) as a direct human food ingredient is based § 184.1324 Glyceryl monostearate. upon the following current good manu- (a) Glyceryl monostearate, also facturing practice conditions of use: known as monostearin, is a mixture of (1) The ingredient is used as a formu- variable proportions of glyceryl mono- lation aid, as defined in § 170.3(o)(14) of stearate (C21H42O4, CAS Reg. No. 31566– this chapter. 31–1), glyceryl monopalmitate (2) The ingredient is used in excipient (C19H38O4, CAS Reg. No. 26657–96–5) and formulations for use in tablets at levels glyceryl esters of fatty acids present in not to exceed good manufacturing commercial stearic acid. Glyceryl practice. monostearate is prepared by [52 FR 42430, Nov. 5, 1987] glycerolysis of certain fats or oils that are derived from edible sources or by § 184.1329 Glyceryl palmitostearate. esterification, with glycerin, of stearic (a) Glyceryl palmitostearate is a acid that is derived from edible mixture of mono-, di-, and triglyceryl sources. esters of palmitic and stearic acids (b) The ingredient must be of a pu- made from glycerin, palmitic acid, and rity suitable for its intended use. stearic acid. (c) In accordance with § 184.1(b)(1), (b) The ingredient meets the fol- the ingredient is used in food with no lowing specifications: limitation other than current good (1) The substance is a mixture of manufacturing practice. mono-, di-, and triglycerides of pal- (d) Prior sanctions for this ingredient mitic acid and stearic acid. different from the uses established in (2) Heavy metals (as lead): Not more than 10 parts per million.

529

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00539 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1330 21 CFR Ch. I (4–1–15 Edition)

(c) In accordance with § 184.1(b)(1), branches of trees of various species of the ingredient is used in food with no the genus Acacia, family Leguminosae. limitation other than current good (b) The ingredient meets the speci- manufacturing practice. The affirma- fications of the ‘‘Food Chemicals tion of this ingredient as generally rec- Codex,’’ 3d Ed. (1981), p. 7, which is in- ognized as safe (GRAS) as a direct corporated by reference. Copies may be human food ingredient is based upon obtained from the National Academy the following current good manufac- Press, 2101 Constitution Ave. NW., turing practice conditions of use: Washington, DC 20418, or may be exam- (1) The ingredient is used as a formu- lation aid, as defined in § 170.3(o)(14) of ined at the National Archives and this chapter. Records Administration (NARA). For (2) The ingredient is used in excipient information on the availability of this formulations for use in tablets at levels material at NARA, call 202–741–6030, or not to exceed good manufacturing go to: http://www.archives.gov/ practice. federallregister/ codeloflfederallregulations/ [60 FR 63621, Dec. 12, 1995] ibrllocations.html. § 184.1330 Acacia (gum arabic). (c) The ingredient is used in food under the following conditions: (a) Acacia (gum arabic) is the dried gummy exudate from stems and

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 thick- ener, § 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 chap- ter; humectant, § 170.3(o)(16) of this chapter; sur- face-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; sta- bilizer and thickener, § 170.3(o)(28) of this chapter; surface-finishing agent, § 170.3(o)(30) of this chap- ter. Dairy product analogs, § 170.3(n)(10) of this chapter ...... 1.3 Formulation aid, § 170.3(o)(14) of this chapter; sta- bilizer 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; sta- bilizer 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 chap- ter.; 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 chap- ter. Nuts and nut products, § 170.3(n)(32) of this chapter ...... 8.3 Formulation aid, § 170.3(o)(14) of this chapter; sur- face-finishing agent, § 170.3(o)(30) of this chapter. Quiescently frozen confection products ...... 6.0 Formulation aid, § 170.3(o)(14) of this chapter; sta- bilizer 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 chap- ter. 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 chap- ter; 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 chap- ter; surface-finishing agent, § 170.3(o)(30) of this chapter.

530

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00540 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1339

MAXIMUM USAGE LEVELS PERMITTED—Continued

Food (as served) Percent Function

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 thick- ener, § 170.3(o)(28) of this chapter; surface-fin- ishing agent, § 170.3(o)(30) of this chapter; texturizer, § 170.3(o)(32) of this chapter.

(d) [Reserved] (3) Loss on drying. Not more than 14 (e) Prior sanctions for this ingredient percent dried at 105 °C for 5 hours. different from the uses established in (4) Identification test. Add 0.2 ml of di- this section do not exist or have been luted lead acetate as outlined in ‘‘Offi- waived. cial Methods of Analysis of the Asso- [42 FR 14653, Mar. 15, 1977, as amended at 42 ciation of Official Analytical Chem- FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, ists,’’ 13th Ed. (1980), section 31.178(b), 1983; 53 FR 5766, Feb. 26, 1988] p. 529, under ‘‘Dilute Basic Lead Ace- tate Standard Solution,’’ which is in- § 184.1333 Gum ghatti. corporated by reference (Copies are (a) Gum ghatti (Indian gum) is an available from the AOAC INTER- exudate from wounds in the bark of NATIONAL, 481 North Frederick Ave., Anogeissus latifolia, a large tree found suite 500, Gaithersburg, MD 20877, or in the dry deciduous forests of India may be examined at the National Ar- and Ceylon. chives and Records Administration (b) The ingredient complies with the (NARA). For information on the avail- following specifications: ability of this material at NARA, call (1) Viscosity of a 1-percent solution. 202–741–6030, or go to: http:// Not less than the minimum or within www.archives.gov/federallregister/ the range claimed by the vendor. code of federal regulations/ (2) Limits of impurities—(i) Arsenic (as l l l AL). Not more than 3 parts per million ibrllocations.html.), to 5 ml of a cold 1- (0.0003 percent); in-100 aqueous solution of the gum. An (ii) Ash (acid-insoluble). Not more immediate, voluminous, opaque pre- than 1.75 percent; cipitate indicates acacia. A small pre- (iii) Ash (total). Not more than 6.0 cipitate or clear solution which pro- percent; duces an opaque flocculent precipitate (iv) Heavy metals (as Pb). Not more upon the addition of 1 ml of 3 N than 40 parts per million (0.004 per- ammonimum hydroxide indicates gum cent); and ghatti. (v) Lead. Not more than 10 parts per (c) The ingredient is used in food million (0.001 percent). 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 § 184.1339 Guar gum. different from the uses established in (a) Guar gum is the natural sub- this section do not exist or have been stance obtained from the maceration of waived. the seed of the guar plant, Cyamopsis [42 FR 14653, Mar. 15, 1977, as amended at 49 tetragonoloba (Linne) Taub., or FR 5612, Feb. 14, 1984] Cyamopsis psoraloides (Lam.) D.C.

531

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00541 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1343 21 CFR Ch. I (4–1–15 Edition)

(b) The ingredient meets the speci- information on the availability of this fications of the ‘‘Food Chemicals material at NARA, call 202–741–6030, or Codex,’’ 3d Ed. (1981), p. 141, which is in- go to: http://www.archives.gov/ corporated by reference. Copies may be federallregister/ obtained from the National Academy codeloflfederallregulations/ Press, 2101 Constitution Ave. NW., ibrllocations.html. Washington, DC 20418, or may be exam- (c) The ingredient is used in food ined at the National Archives and under the following conditions: Records Administration (NARA). For

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 chap- ter; 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; sta- bilizer 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; formula- tion 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; sta- bilizer 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. 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 chap- ter; formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chap- ter.

(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), pp. 174–175, 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. [42 FR 14653, Mar. 15, 1977, as amended at 42 NW., Washington, DC 20418, or may be FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, examined at the National Archives and 1984] Records Administration (NARA). For information on the availability of this § 184.1343 Locust (carob) bean gum. material at NARA, call 202–741–6030, or (a) Locust (carob) bean gum is pri- go to: http://www.archives.gov/ marily the macerated endosperm of the federallregister/ seed of the locust (carob) bean tree, codeloflfederallregulations/ Ceratonia siliqua (Linne), a leguminous ibrllocations.html. evergreen tree, with lesser quantities (c) The ingredient is used at levels of seed coat and germ. not to exceed the following maximum levels:

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.

532

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00542 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1351

MAXIMUM USAGE LEVELS PERMITTED—Continued

Food (as served) Percent Function

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] Codex,’’ 3d Ed. (1981), p. 157, 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 regulation do not exist or have Press, 2101 Constitution Ave. NW., been 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 § 184.1349 Karaya gum (sterculia gum). go to: http://www.archives.gov/ (a) Karaya gum (sterculia gum) is the federallregister/ dried gummy exudate from the trunk codeloflfederallregulations/ of trees of various species of the genus ibrllocations.html. Sterculia. (c) The ingredient is used in food (b) The ingredient meets the speci- under the following conditions: fications of the ‘‘Food Chemicals

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] (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. 337, which is in- this section do not exist or have been corporated by reference. Copies may be 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 § 184.1351 Gum tragacanth. material at NARA, call 202–741–6030, or (a) Gum tragacanth is the exudate go to: http://www.archives.gov/ from one of several species of Astrag- federallregister/ alus gummifier Labillardiere, a shrub codeloflfederallregulations/ that grows wild in mountainous re- ibrllocations.html. gions of the Middle East. (c) The ingredient is used in food under the following conditions:

533

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00543 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1355 21 CFR Ch. I (4–1–15 Edition)

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] (d) Prior sanctions for this ingredient (e) 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. [48 FR 57270, Dec. 29, 1983, as amended at 73 [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 8607, Feb. 14, 2008] FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, 1984] § 184.1366 Hydrogen peroxide.

§ 184.1355 Helium. (a) Hydrogen peroxide (H2O2, CAS (a) Helium (empirical formula He, Reg. No. 7722–84–1) is also referred to as CAS Reg. No. 7440–59–7) is a colorless, hydrogen dioxide. It is made by the odorless, flavorless, nonflammable, electrolytic oxidation of sulfuric acid inert gas. It is lighter than air and is or a sulfate to persulfuric acid or a produced by the liquefaction and puri- persulfuric acid salt with subsequent fication of natural gas. hydrolysis and distillation of the hy- (b) The ingredient must be of a pu- drogen peroxide formed; by decomposi- rity suitable for its intended use. tion of barium peroxide with sulfuric (c) In accordance with § 184.1(b)(1), or phosphoric acid; by hydrogen reduc- the ingredient is used in food with no tion of 2-ethylanthraquinone, followed limitations other than current good by oxidation with air, to regenerate manufacturing practice. The affirma- the quinone and produce hydrogen per- tion of this ingredient as generally rec- oxide; or by electrical discharge ognized as safe (GRAS) as a direct through a mixture of hydrogen, oxy- human food ingredient is based upon gen, and water vapor. the following current good manufac- (b) The ingredient meets the speci- turing practice conditions of use: fications of the Food Chemicals Codex, (1) The ingredient is used as a proc- 3d ed. (1981), pp. 146–147, 1 which is in- essing aid as defined in § 170.3(o)(24) of corporated by reference. this chapter. (c) In accordance with § 184.1(b)(2), (2) The ingredient is used in food at the ingredient is used to treat food levels not to exceed current good man- only within the following specific limi- ufacturing practice. tations:

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

534

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00544 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1370

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 refin- ing. 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.

(d) Residual hydrogen peroxide is re- spection at the National Archives and moved by appropriate physical and Records Administration (NARA). For chemical means during the processing information on the availability of this of food where it has been used accord- material at NARA, call 202–741–6030, or ing to paragraph (c) of this section. go to: http://www.archives.gov/ (e) 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 with no [46 FR 44439, Sept. 4, 1981, as amended at 51 limitations other than current good FR 27172, July 30, 1986] manufacturing practice. The affirma- tion of this ingredient as generally rec- § 184.1370 Inositol. ognized as safe (GRAS) as a direct (a) Inositol, or myo-inositol (C6H12O6, human food ingredient is based upon CAS Reg. No. 87–89–8), is cis-1,2,3,5- the following current good manufac- trans-4,6-cyclohexanehexol. It occurs turing practice conditions of use: naturally and is prepared from an (1) The ingredient is used as a nutri- aqueous (0.2 percent sulfur dioxide) ex- ent supplement as defined in tract of corn kernels by precipitation § 170.3(o)(20) of this chapter. and hydrolysis of crude phytate. (2) The ingredient is used in special (b) The ingredient meets the speci- dietary foods as defined in part 105 of fications of the Food Chemicals Codex, this chapter at levels not to exceed 3d Ed. (1981), p. 150, which is incor- current good manufacturing practice. porated by reference. Copies are avail- It may also be used in infant formula able from the National Academy Press, in accordance with section 412(g) of the 2101 Constitution Ave. NW., Wash- Act, or with regulations promulgated ington, DC 20418, or available for in- under section 412(a)(2) of the Act.

535

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00545 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1372 21 CFR Ch. I (4–1–15 Edition)

(d) Prior sanctions for this ingredient ceed current good manufacturing prac- different from the uses established by tice. this section do not exist or have been [48 FR 5720, Feb. 8, 1983, as amended at 61 FR waived. 43450, Aug. 23, 1996] [47 FR 38278, Aug. 31, 1982] § 184.1375 Iron, elemental. § 184.1372 Insoluble glucose isomerase (a) Iron, elemental (CAS Reg. No. enzyme preparations. 7439–89–6) is metallic iron obtained by any of the following processes: reduced (a) Insoluble glucose isomerase en- iron, electrolytic iron, and carbonyl zyme preparations are used in the pro- iron. duction of high fructose corn syrup de- (1) Reduced iron is prepared by react- scribed in § 184.1866. They are derived ing ground ferric oxide with hydrogen from recognized species of precisely or carbon monoxide at an elevated classified nonpathogenic and temperature. The process results in a nontoxicogenic microorganisms, in- grayish-black powder, all of which cluding Streptomyces rubiginosus, should pass through a 100-mesh sieve. Actinoplanes missouriensis, Streptomyces It is lusterless or has not more than a olivaceus, Streptomyces olivochromogenes, slight luster. When viewed under a mi- and Bacillus coagulans, that have been croscope, it appears as an amorphous grown in a pure culture fermentation powder free from particles having a that produces no antibiotics. They are crystalline structure. It is stable in dry fixed (rendered insoluble) for batch air. production with GRAS ingredients or (2) Electrolytic iron is prepared by may be fixed for further immobiliza- electrodeposition. It is an amorphous, tion with either GRAS ingredients or lusterless, grayish-black powder. It is materials approved under § 173.357 of stable in dry air. this chapter. (3) Carbonyl iron is prepared by the (b) The ingredient meets the general decomposition of iron pentacarbonyl. and additional requirements for en- It occurs as a dark gray powder. When zyme preparations in the Food Chemi- viewed under a microscope, it appears cals Codex, 3d Ed. (1981), p. 107, which is as spheres built up with concentric incorporated by reference. Copies are shells. It is stable in dry air. available from the National Academy (b) Iron, elemental (carbonyl, elec- Press, 2101 Constitution Ave. NW., trolytic, or reduced) meets the speci- Washington, DC 20418, or available for fications of the Food Chemicals Codex, 3d Ed. (1981) (iron, carbonyl, p. 151; inspection at the National Archives iron, electrolytic, pp. 151–152; iron, re- and Records Administration (NARA). duced; pp. 152–153), which is incor- For information on the availability of porated by reference. Copies are avail- this material at NARA, call 202–741– able from the National Academy Press, 6030, or 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 as a nu- turing practice conditions of use: trient supplement as defined in (1) The ingredient is used as an en- § 170.3(o)(20) of this chapter, with no zyme, as defined in § 170.3(o)(9) of this limitation other than current good chapter, to convert glucose to fructose. manufacturing practice. The ingre- (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,

536

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00546 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1388

Drug, and Cosmetic Act (the act) (21 tose. It is prepared from yeast that has U.S.C. 350a(g)) or with regulations pro- been grown by a pure culture fermenta- mulgated under section 412(a)(2) of the tion process. act (21 U.S.C. 350a(2)). (b) The ingredient meets the general (d) Prior sanctions for this ingredient requirements and additional require- different from the uses established in ments for enzyme preparations in the this section do not exist or have been Food Chemicals Codex, 3d ed. (1981), pp. waived. 107–110, which are incorporated by ref- erence in accordance with 5 U.S.C. [53 FR 16867, May 12, 1988] 552(a) and 1 CFR part 51. Copies are § 184.1386 Isopropyl citrate. available from the National Academy Press, 2101 Constitution Ave. NW., (a) Isopropyl citrate is a mixture of Washington, DC 20418, or may be exam- the mono-, di-, and triisopropyl esters ined at the Center for Food Safety and of citric acid. It is prepared by Applied Nutrition’s Library, 5100 Paint esterifying citric acid with Branch Pkwy., College Park, MD 20740, isopropanol. or at the National Archives and (b) The ingredient must be of a pu- Records Administration (NARA). For rity suitable for its intended use. 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- limitations other than current good turing practice conditions of use: manufacturing practice. The affirma- (1) The ingredient is used as an anti- tion of this ingredient as generally rec- oxidant as defined in § 170.3(o)(3) of this ognized as safe as a direct human food chapter; a sequestrant as defined in ingredient is based upon the following § 170.3(o)(26) of this chapter; and a sol- current good manufacturing practice vent and vehicle as defined in conditions of use: § 170.3(o)(27) of this chapter. (1) The ingredient is used as an en- (2) The ingredient is used in mar- zyme, as defined in § 170.3(o)(9) of this garine in accordance with § 166.110 of chapter, to convert lactose to glucose this chapter; in nonalcoholic beverages and galactose. as defined in § 170.3(n)(3) of this chap- (2) The ingredient is used in food at ter; and in fats and oils as defined in levels not to exceed current good man- § 170.3(n)(12) of this chapter at levels ufacturing practice. Current good man- not to exceed current good manufac- ufacturing practice is limited to use of turing practice. this ingredient to reduce the lactose (d) Prior sanctions for this ingredient content in milk and milk-derived food different from the uses established in products where food standards do not this section, or different from those set preclude such use. forth in part 181 of this chapter, do not [61 FR 7704, Feb. 29, 1996] exist or have been waived. [59 FR 63896, Dec. 12, 1994, as amended at 73 § 184.1388 Lactase enzyme preparation FR 8607, Feb. 14, 2008] from Kluyveromyces lactis. (a) This enzyme preparation is de- § 184.1387 Lactase enzyme preparation rived from the nonpathogenic, from Candida pseudotropicalis. nontoxicogenic yeast Kluyveromyces (a) This enzyme preparation is de- lactis (previously named Saccharomyces rived from the nonpathogenic, lactis). It contains the enzyme B- nontoxicogenic yeast C. galactoside galactohydrase (CAS Reg. pseudotropicalis. It contains the enzyme No. CBS 683), which converts lactose to lactase (b-D-galactoside glucose and galactose. It is prepared 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

537

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00547 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1400 21 CFR Ch. I (4–1–15 Edition)

materials that are generally recognized able from the National Academy Press, as safe or are food additives that have 2101 Constitution Ave. NW., Wash- been approved for this use by the Food ington, DC 20418, or available for in- and Drug Administration. spection at the National Archives and (b) The ingredient meets the general Records Administration (NARA). For and additional requirements for en- information on the availability of this zyme preparations in the Food Chemi- material at NARA, call 202–741–6030, or cals Codex, 3d Ed. (1981), p. 107–110, go to: http://www.archives.gov/ which is incorporated by reference. federallregister/ Copies are available from the National codeloflfederallregulations/ Academy Press, 2101 Constitution Ave. ibrllocations.html. NW., Washington, DC 20418, or avail- (c) In accordance with § 184.1(b)(1), able for inspection at the National Ar- the ingredient is used in food with no chives and Records Administration limitation other than current good (NARA). For information on the avail- manufacturing practice. ability of this material at NARA, call (d) Prior sanctions for this ingredient 202–741–6030, or go to: http:// different from the uses established in www.archives.gov/federallregister/ this section do not exist or have been codeloflfederallregulations/ waived. ibrllocations.html. (c) In accordance with § 184.1(b)(1), [48 FR 51150, Nov. 7, 1983] the ingredient is used in food with no limitation other than current good § 184.1408 Licorice and licorice deriva- manufacturing practice. The affirma- tives. tion of this ingredient as generally rec- (a)(1) Licorice (glycyrrhiza) root is ognized as safe as a direct human food the dried and ground rhizome and root ingredient is based upon the following portions of Glycyrrhiza glabra or other current good manufacturing practice species of Glycyrrhiza. Licorice extract conditions of use: is that portion of the licorice root that (1) The ingredient is used as an en- is, after maceration, extracted by boil- zyme as defined in § 170.3(o)(9) of this ing water. The extract can be further chapter to convert lactose to glucose purified by filtration and by treatment and galactose. with acids and ethyl alcohol. Licorice (2) The ingredient is used in food at extract is sold as a liquid, paste levels not to exceed current good man- (‘‘block’’), or spray-dried powder. ufacturing practice. Current good man- (2) Ammoniated glycyrrhizin is pre- ufacturing practice is to use this ingre- pared from the water extract of lico- dient in milk to produce lactase-treat- rice root by acid precipitation followed ed milk, which contains less lactose by neutralization with dilute ammonia. than regular milk, or lactose-reduced Monoammonium glycyrrhizinate milk, which contains at least 70 per- (C42H61O16NH45H2O, CAS Reg. No. 1407– cent less lactose than regular milk. 03–0) is prepared from ammoniated [49 FR 47387, Dec. 4, 1984] glycyrrhizin by solvent extraction and separation techniques. § 184.1400 Lecithin. (b) The ingredients shall meet the (a) Commercial lecithin is a natu- following specifications when analyzed: rally occurring mixture of the (1) Assay. The glycyrrhizin content of phosphatides of choline, ethanolamine, each flavoring ingredient shall be de- and inositol, with smaller amounts of termined by the method in the Official othe lipids. It is isolated as a gum fol- Methods of Analysis of the Association lowing hydration of solvent-extracted of Official Analytical Chemists, 13th soy, safflower, or corn oils. Lecithin is Ed., §§ 19.136–19.140, which is incor- bleached, if desired, by hydrogen per- porated by reference, or by methods oxide and benzoyl peroxide and dried 19.CO1 through 19.CO4 in the Journal of by heating. the Association of Official Analytical (b) The ingredient meets the speci- Chemists, 65:471–472 (1982), which are fications of the Food Chemicals Codex, also incorporated by reference. Copies 3d Ed. (1981), pp. 166–167, which is incor- of all of these methods are available porated by reference. Copies are avail- from the AOAC INTERNATIONAL, 481

538

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00548 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1409

North Frederick Ave., suite 500, Gai- go to: http://www.archives.gov/ thersburg, MD 20877, or available for federallregister/ inspection at the National Archives codeloflfederallregulations/ and Records Administration (NARA). ibrllocations.html. For information on the availability of (3) Acid unsoluble ash. Not more than this material at NARA, call 202–741– 2.5 percent for licorice on an anhydrous 6030, or go to: http://www.archives.gov/ basis as determined by the method in federallregister/ the Food Chemicals Codex, 3d Ed. codeloflfederallregulations/ (1981), p. 466, which is incorporated by ibrllocations.html. reference. (2) Ash. Not more than 9.5 percent for (4) Heavy metals (as Pb). Not more licorice, 2.5 percent for ammoniated than 40 parts per million as determined glycyrrhizin, and 0.5 percent for by method II in the Food Chemicals monoammonium glycyrrhizinate on an anhydrous basis as determined by the Codex, 3d Ed. (1981), p. 512, which is in- method in the Food Chemicals Codex, corporated by reference. 3d Ed. (1981), p. 466, which is incor- (5) Arsenic (As). Not more than 3 parts porated by reference. Copies are avail- per million as determined by the meth- able from the National Academy Press, od in the Food Chemicals Codex. 3d Ed. 2101 Constitution Ave. NW., Wash- (1981), p. 464, which is incorporated by ington, DC 20418, or available for in- reference. spection at the National Archives and (c) In accordance with § 184.1(b)(2), Records Administration (NARA). For these ingredients are used in food only information on the availability of this within the following specific limita- material at NARA, call 202–741–6030, or tions:

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; fla- voring 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; fla- voring agent, § 170.3(o)(12) of this chapter; sur- face-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; fla- voring 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 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 classifying of naturally occurring lime- different from the uses established in stone. this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the Food Chemicals Codex, 3d Ed. (1981), p. 173, which is incor- [50 FR 21044, May 22, 1985, as amended at 54 FR 24899, June 12, 1989] porated by reference. Copies are avail- able from the National Academy Press, § 184.1409 Ground limestone. 2101 Constitution Ave. NW., Wash- ington, DC 20418, or available for in- (a) Ground limestone consists essen- spection at the National Archives and tially (not less than 94 percent) of cal- Records Administration (NARA). For cium carbonate (CaCO ) and is prepared 3 information on the availability of this by the crushing, grinding, and material at NARA, call 202–741–6030, or

539

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00549 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1415 21 CFR Ch. I (4–1–15 Edition)

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. ibrllocations.html. (c) In accordance with § 184.1(b)(1), [60 FR 32911, June 26, 1995, as amended at 78 the ingredient is used in food with no FR 14666, Mar. 7, 2013] limitation other than current good manufacturing practice. § 184.1420 Lipase enzyme preparation derived from Rhizopus niveus. (d) Prior sanctions for this ingredient different from the uses established in (a) Lipase enzyme preparation con- this section do not exist or have been tains lipase enzyme (CAS Reg. No. waived. 9001–62–1), which is obtained from the [48 FR 52442, Nov. 18, 1983] culture filtrate resulting from a pure culture fermentation of a nonpatho- § 184.1415 Animal lipase. genic and nontoxigenic strain of (a) Animal lipase (CAS Reg. No. 9001– Rhizopus niveus. The enzyme prepara- 62–1) is an enzyme preparation obtained tion also contains diatomaceous earth from edible forestomach tissue of as a carrier. The characterizing activ- calves, kids, or lambs, or from animal ity of the enzyme, which catalyzes the pancreatic tissue. The enzyme prepara- interesterification of fats and oils at tion may be produced as a tissue prepa- the 1- and 3-positions of triglycerides, ration or as an aqueous extract. Its is triacylglycerol lipase (EC 3.1.1.3). characterizing enzyme activity is that (b) The ingredient meets the general of a triacylglycerol hydrolase (EC requirements and additional require- 3.1.1.3). ments for enzyme preparations in the (b) The ingredient meets the general monograph on Enzyme Preparations in requirements and additional require- the ‘‘Food Chemicals Codex,’’ 4th ed. ments for enzyme preparations in the (1996), pp. 133 and 134, which is incor- Food Chemicals Codex, 3d ed. (1981), p. porated by reference in accordance 110, which is incorporated by reference with 5 U.S.C. 552(a) and 1 CFR part 51. in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from Copies are available from the National the National Academy Press, 2101 Con- Academy Press, 2101 Constitution Ave. stitution Ave., NW., Washington, DC NW., Washington, DC 20418, or may be 20418, or may be examined at the Office examined at the Center for Food Safety of Food Additive Safety (HFS–200), and Applied Nutrition’s Library, 5100 Center for Food Safety and Applied Nu- Paint Branch Pkwy., College Park, MD trition, Food and Drug Administration, 20740, or at the National Archives and 5100 Paint Branch Pkwy., College Park, Records Administration (NARA). For MD 20740, 240–402–1200, and at the Na- information on the availability of this tional Archives and Records Adminis- material at NARA, call 202–741–6030, or tration (NARA). For information on go to: http://www.archives.gov/ the availability of this material at federallregister/ NARA, call 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- limitation other than current good manufacturing practice. The affirma- tion of this ingredient as generally rec- tion of this ingredient as GRAS as a di- ognized as safe as a direct human food rect food ingredient is based upon the ingredient is based upon the following following current good manufacturing current good manufacturing practice practice conditions of use: conditions of use: (1) The ingredient is used as an en- (1) The ingredient is used as an en- zyme as defined in § 170.3(o)(9) of this zyme as defined in § 170.3(o)(9) of this chapter to hydrolyze fatty acid chapter for the interesterification of glycerides. fats and oils.

540

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00550 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1426

(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. [50 FR 13558, Apr. 5, 1985; 50 FR 16080, Apr. 24, [63 FR 24419, May 4, 1998] 1985]

§ 184.1425 Magnesium carbonate. § 184.1426 Magnesium chloride.

(a) Magnesium carbonate (molecular (a) Magnesium chloride (MgC12·6H2O, formula approximately CAS Reg. No. 7786–30–3) is a colorless, (MgCO3)4·Mg(OH)2·5H2O, CAS Reg. No. deliquescent, crystalline material that 39409–82–0) is also known as magnesium occurs naturally as the mineral carbonate hydroxide. It is a white pow- bischofite. It is prepared by dissolving der formed either by adding an alkaline magnesium oxide, hydroxide, or car- carbonate (such as sodium carbonate) bonate in aqueous hydrochloric acid so- to a solution of magnesium sulfate or lution and crystallizing out magnesium by carbonation of a slurry of magne- chloride hexahydrate. sium hydroxide followed by boiling of (b) The ingredient meets the speci- the resulting magnesium carbonate. fications of the Food Chemicals Codex, (b) The ingredient meets the speci- 3d Ed. (1981), p. 177, which is incor- fications of the Food Chemicals Codex, porated by reference. Copies are avail- 3d Ed. (1981), p. 177, which is incor- able from the National Academy Press, porated by reference. Copies are avail- 2101 Constitution Ave. NW., Wash- able from the National Academy Press, ington, DC 20418, or available for in- 2101 Constitution Ave. NW., Wash- spection at the National Archives and ington, DC 20418, or available for in- Records Administration (NARA). For spection at the National Archives and information on the availability of this Records Administration (NARA). For material at NARA, call 202–741–6030, or information on the availability of this go to: http://www.archives.gov/ material at NARA, call 202–741–6030, or federallregister/ 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)(1), limitation other than current good the ingredient is used in food with no manufacturing practice. The affirma- limitation other than current good tion of this ingredient as generally rec- manufacturing practice. The affirma- ognized as safe (GRAS) as a direct tion of this ingredient as generally rec- human food ingredient is based upon ognized as safe (GRAS) as a direct the following current good manufac- human food ingredient is based upon turing practice conditions of use: the following current good manufac- (1) The ingredient is used as a fla- turing practice conditions of use: (1) The ingredient is used as an voring agent and adjuvant as defined in anticaking and free-flow agent as de- § 170.3(o)(12) of this chapter and a nutri- fined in § 170.3(o)(1) of this chapter; a ent supplement as defined in flour treating agent as defined in § 170.3(o)(20) of this chapter. § 170.3(o)(13) of this chapter; a lubricant (2) The ingredient is used in foods at and release agent as defined in levels not to exceed current good man- § 170.3(o)(18) of this chapter; a nutrient ufacturing practice. The ingredient supplement as defined in § 170.3(o)(20) of also may be used in infant formula in this chapter; a pH control agent as de- accordance with section 412(g) of the fined in § 170.3(o)(23) of this chapter; a Federal Food, Drug, and Cosmetic Act processing aid as defined in § 170.3(o)(24) (the act) or with regulations promul- of this chapter; and a synergist as de- gated under section 412(a)(2) of the act. fined in § 170.3(o)(31) 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. waived. (d) Prior sanctions for this ingredient [50 FR 13559, Apr. 5, 1985; 50 FR 16080, Apr. 24, different from the uses established in 1985]

541

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00551 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1428 21 CFR Ch. I (4–1–15 Edition)

§ 184.1428 Magnesium hydroxide. erate conditions (400° to 900 °C for a few hours) produces light magnesium (a) Magnesium hydroxide (Mg(OH)2, CAS Reg. No. 1309–42–8) occurs natu- oxide. Heating the salts under more ° rally as the colorless, crystalline min- rigorous conditions (1200 C for 12 eral brucite. It is prepared as a white hours) produces heavy magnesium precipitate by the addition of sodium oxide. Light magnesium oxide is con- hydroxide to a water soluble magne- verted to heavy magnesium oxide by sium salt or by hydration of reactive sustained heating at high tempera- grades of magnesium oxide. tures. (b) The ingredient meets the speci- (b) The ingredient meets the speci- fications of the Food Chemicals Codex, fications of the Food Chemicals Codex, 3d Ed. (1981), p. 178, which is incor- 3d Ed. (1981), p. 178, which is incor- porated by reference. Copies are avail- porated by reference. Copies are avail- able 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 in- spection 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. (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- limitation other than current good tion of this ingredient as generally rec- manufacturing practice. The affirma- ognized as safe (GRAS) as a direct tion of this ingredient as generally rec- human food ingredient is based upon ognized as safe (GRAS) as a direct the following current good manufac- human food ingredient is based upon turing practice conditions of use: the following current good manufac- (1) The ingredient is used as a nutri- turing practice conditions of use: ent supplement as defined in (1) The ingredient is used as an § 170.3(o)(20) of this chapter; a pH con- anticaking and free-flow agent as de- trol agent as defined in § 170.3(o)(23) of fined in § 170.3(o)(1) of this chapter; a this chapter; and a processing aid as firming agent as defined in § 170.3(o)(10) defined in § 170.3(o)(24) of this chapter. of this chapter; a lubricant and release (2) The ingredient is used in foods at agent as defined in § 170.3(o)(18) of this levels not to exceed current good man- chapter; a nutrient supplement as de- ufacturing practice. fined in § 170.3(o)(20) of this chapter; (d) Prior sanctions for this ingredient and a pH control agent as defined in different from the uses established in § 170.3(o)(23) of this chapter. this section do not exist or have been (2) The ingredient is used in foods at waived. levels not be exceed current good man- [50 FR 13559, Apr. 5, 1985, as amended at 64 ufacturing practice. The ingredient FR 405, Jan. 5, 1999] also may be used in infant formula in accordance with section 412(g) of the § 184.1431 Magnesium oxide. Federal Food, Drug, and Cosmetic Act (a) Magnesium oxide (MgO, CAS Reg. (the act) or with regulations promul- No. 1309–48–4) occurs naturally as the gated under section 412(a)(2) of the act. colorless, crystalline mineral periclase. (d) Prior sanctions for this ingredient It is produced either as a bulky white different from the uses established in powder (light) or a relatively dense this section do not exist or have been white powder (heavy) by heating mag- waived. nesium hydroxide or carbonate. Heat- ing these magnesium salts under mod- [50 FR 13559, Apr. 5, 1985]

542

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00552 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1440

§ 184.1434 Magnesium phosphate. (d) Prior sanctions for this ingredient (a) Magnesium phosphate includes different from the uses established in both magnesium phosphate, dibasic, this section do not exist or have been and magnesium phosphate, tribasic. waived. Magnesium phosphate, dibasic [50 FR 13560, Apr. 5, 1985, as amended at 69 (MgHPO4·3H2O, CAS Reg. No. 7782–0975– FR 24512, May 4, 2004] 094) occurs naturally as the white, crystalline mineral newberyite. It is § 184.1440 Magnesium stearate. prepared commercially as a precipitate (a) Magnesium stearate formed by treating a solution of mag- (Mg(C H COO) , CAS Reg. No. 557–04– nesium sulfate with disodium phos- 17 34 2 0) is the magnesium salt of stearic phate under controlled conditions. acid. It is produced as a white precipi- Magnesium phosphate, tribasic tate by the addition of an aqueous so- (Mg (PO )2·xH O, CAS Reg. No. 7757–87– 3 4 2 lution of magnesium chloride to an 1) may contain 4, 5, or 8 molecules of water of hydration. It is produced as a aqueous solution of sodium stearate de- precipitate from a solution of mag- rived from stearic acid that is obtained nesite with phosphoric acid. from edible sources and that conforms (b) Magnesium phosphate, dibasic, to the requirements of § 172.860(b)(2) of meets the specifications of the Food this chapter. Chemicals Codex, 3d Ed. (1981), p. 179, (b) The ingredient meets the speci- which is incorporated by reference. fications of the Food Chemicals Codex, Magnesium phosphate, tribasic, meets 3d Ed. (1981), p. 182, which is incor- the specifications of the Food Chemi- porated by reference. Copies are avail- cals Codex, 3d Ed. (1981), p. 180, which is able from the National Academy Press, incorporated by reference. Copies are 2101 Constitution Ave. NW., Wash- available from the National Academy ington, DC 20418, or available for in- Press, 2101 Constitution Ave. NW., spection at the National Archives and Washington, DC 20418, or available for Records Administration (NARA). For inspection at the National Archives information on the availability of this and Records Administration (NARA). material at NARA, call 202–741–6030, or For information on the availability of go to: http://www.archives.gov/ this material at NARA, call 202–741– federallregister/ 6030, or 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)(1), limitation other than current good the ingredient is used in food with no manufacturing practice. The affirma- limitation other than current good tion of this ingredient as generally rec- manufacturing practice. The affirma- ognized as safe (GRAS) as a direct tion of this ingredient as generally rec- human food ingredient is based upon ognized as safe (GRAS) as a direct the following current good manufac- human food ingredient is based upon turing practice conditions of use: the following current good manufac- (1) The ingredient is used as a lubri- turing practice conditions of use: cant and release agent as defined in (1) The ingredient is used as a nutri- § 170.3(o)(18) of this chapter; a nutrient ent supplement as defined in supplement as defined in § 170.3(o)(20) of § 170.3(o)(20) of this chapter and a pH this chapter; and a processing aid as control agent as defined in § 170.3(o)(23) defined in § 170.3(o)(24) of this chapter. of this chapter. (2) The ingredient is used in foods at (2) The ingredient is used in foods at levels not to exceed current good man- levels not to exceed current good man- ufacturing practice. ufacturing practice. The ingredient (d) Prior sanctions for this ingredient also may be used in infant formula in different from the uses established in 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- gated under section 412(a)(2) of the Act. [50 FR 13560, Apr. 5, 1985]

543

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00553 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1443 21 CFR Ch. I (4–1–15 Edition)

§ 184.1443 Magnesium sulfate. (b) The ingredient meets the general requirements and additional require- (a) Magnesium sulfate (MgSO4·7H2O, ments for enzyme preparations in the CAS Reg. No. 10034–99–8) occurs natu- Food Chemicals Codex, 3d ed. (1981), p. rally as the mineral epsomite. It is pre- 110, which is incorporated by reference pared by neutralization of magnesium in accordance with 5 U.S.C. 552(a) and 1 oxide, hydroxide, or carbonate with CFR part 51. Copies are available from sulfuric acid and evaporating the solu- the National Academy Press, 2101 Con- tion to . stitution Ave., NW., Washington, DC (b) The ingredient meets the speci- 20418, or may be examined at the Office fications of the Food Chemicals Codex, of Premarket Approval (HFS–200), Food 3d Ed. (1981), p. 183, which is incor- and Drug Administration, 5100 Paint porated by reference. Copies are avail- Branch Pkwy., College Park, MD 20740, able from the National Academy Press, and 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 GRAS as a di- limitation other than current good rect food ingredient is based upon the manufacturing practice. The affirma- following current good manufacturing tion of this ingredient as generally rec- practice conditions of use: ognized as safe (GRAS) as a direct (1) The ingredient is used as an en- human food ingredient is based upon zyme as defined in § 170.3(o)(9) of this the following current good manufac- chapter to hydrolyze starch or starch- turing practice conditions of use: derived polysaccharides. (1) The ingredient is used as a flavor (2) The ingredient is used in food at enhancer as defined in § 170.3(o)(11) of levels not to exceed current good man- this chapter; a nutrient supplement as ufacturing practice. defined in § 170.3(o)(20) of this chapter; [60 FR 32911, June 26, 1995] and a processing aid as defined in § 170.3(o)(24) of this chapter. § 184.1444 Maltodextrin.

(2) The ingredient is used in foods at (a) Maltodextrin ((C6H10O5)n, CAS levels not to exceed current good man- Reg. No. 9050–36–6) is a nonsweet nutri- ufacturing practice. tive saccharide polymer that consists (d) Prior sanctions for this ingredient of D-glucose units linked primarily by different from the uses established in a-1-4 bonds and that has a dextrose this section do not exist or have been equivalent (D.E.) of less than 20. It is waived. prepared as a white powder or con- centrated solution by partial hydrol- [50 FR 13560, Apr. 5, 1985] ysis of corn starch, potato starch, or rice starch with safe and suitable acids § 184.1443a Malt. and enzymes. (a) Malt is an enzyme preparation ob- (b)(1) Maltodextrin derived from corn tained from barley which has been soft- starch must be of a purity suitable for ened by a series of steeping operations its intended use. and germinated under controlled condi- (2) Maltodextrin derived from potato tions. It is a brown, sweet, and viscous starch meets the specifications of the liquid or a white to tan powder. Its Food Chemicals Codex, 3d ed., 3d supp. 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

544

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00554 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1446

available from the National Academy ened after cleaning by steeping oper- Press, 2101 Constitution Ave., NW., ations and then allowed to germinate Washington, DC 20418, or at the Divi- under controlled conditions. The ger- sion of Petition Control (HFS–217), minated grain then undergoes proc- Center for Food Safety and Applied Nu- essing, such as drying, grinding, ex- trition, Food and Drug Administration, tracting, filtering, and evaporating, to 5100 Paint Branch Pkwy., College Park, produce malt syrup (malt extract) with MD 20740, or may be examined at the 75 to 80 percent solids or dried malt National Archives and Records Admin- syrup with higher solids content. istration (NARA). For information on (b) The ingredient must be of a pu- the availability of this material at rity suitable for its intended use. NARA, call 202–741–6030, or go to: http:// (c) In accordance with § 184.1(b)(1), www.archives.gov/federallregister/ the ingredient is used in food with no codeloflfederallregulations/ limitation other than current good ibrllocations.html.. manufacturing practice. The affirma- (3) Maltodextrin derived from rice tion of this ingredient as generally rec- starch meets the specifications of the ognized as safe (GRAS) as a direct Food Chemicals Codex, 4th ed. (1996), human food ingredient is based upon pp. 239 and 240, which is incorporated the following current good manufac- by reference in accordance with 5 turing practice conditions of use: U.S.C. 552(a) and 1 CFR part 51. Copies (1) The ingredient is used as a fla- are available from the National Acad- voring agent and adjuvant as defined in emy Press, 2101 Constitution Ave. NW., § 170.3(o)(12) of this chapter. Washington, DC 20418, or may be exam- (2) The ingredient is used in food at ined at the Center for Food Safety and levels not to exceed current good man- Applied Nutrition’s Library, 5100 Paint ufacturing practice. Branch Pkwy., College Park, MD 20740, (d) Prior sanctions for this ingredient or 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 [48 FR 51613, Nov. 10, 1983, as amended at 73 go to: http://www.archives.gov/ FR 8607, Feb. 14, 2008] federallregister/ codeloflfederallregulations/ § 184.1446 Manganese chloride. ibrllocations.html. (a) Manganese chloride (MnCl2, CAS (c) In accordance with § 184.1(b)(1), Reg. No. 7773–01–5) is a pink, trans- the ingredient is used in food with no lucent, crystalline product. It is also limitation other than current good known as manganese dichloride. It is manufacturing practice. prepared by dissolving manganous (d) Prior sanctions for this ingredient oxide, pyrolusite ore (MnO2), or re- different from the uses established in duced manganese ore in hydrochloric this section do not exist or have been acid. The resulting solution is neutral- waived. ized to precipitate heavy metals, fil- [48 FR 51911, Nov. 15, 1983; as amended at 60 tered, concentrated, and crystallized. FR 48893, Sept. 21, 1995; 63 FR 14611, Mar. 26, (b) The ingredient meets the speci- 1998] fications of the Food Chemicals Codex, 3d Ed. (1981), p. 186, which is incor- § 184.1445 Malt syrup (malt extract). porated by reference. Copies are avail- (a) Malt is the product of barley able from the National Academy Press, (Hordeum vulgare L.) germinated under 2101 Constitution Ave. NW., Wash- controlled conditions. Malt syrup and ington, DC 20418, or available for in- malt extract are interchangeable terms spection at the National Archives and for a viscous concentrate of water ex- Records Administration (NARA). For tract of germinated barley grain, with information on the availability of this or without added safe preservative. material at NARA, call 202–741–6030, or Malt syrup is usually a brown, sweet, go to: http://www.archives.gov/ and viscous liquid containing varying federallregister/ amounts of amylolytic enzymes and codeloflfederallregulations/ plant constituents. Barley is first soft- ibrllocations.html.

545

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00555 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1449 21 CFR Ch. I (4–1–15 Edition)

(c) In accordance with § 184.1(b)(1), ucts as defined in § 170.3(n)(13) of this the ingredient is used in food with no chapter; meat products as defined in limitation other than current good § 170.3(n)(29) of this chapter; milk prod- manufacturing practice. The affirma- ucts as defined in § 170.3(n)(31) of this tion of this ingredient as generally rec- chapter; and poultry products as de- ognized as safe (GRAS) as a direct fined in § 170.3(n)(34) of this chapter. human food ingredient is based upon The ingredient may be used in infant the following current good manufac- formulas in accordance with section turing practice conditions of use: 412(g) of the Federal Food, Drug, and (1) The ingredient is used as a nutri- Cosmetic Act (the act) or with regula- ent supplement as defined in tions promulgated under section § 170.3(o)(20) of this chapter. 412(a)(2) of the act. (2) The ingredient may be used in in- (d) Prior sanctions for this ingredient fant formulas in accordance with sec- different from the uses established in tion 412(g) of the Federal Food, Drug, this section do not exist or have been and Cosmetic Act (the act) or with reg- waived. ulations promulgated under section [50 FR 19166, May 7, 1985, as amended at 73 412(a)(2) of the act. FR 8607, Feb. 14, 2008; 76 FR 59250, Sept. 26, (d) Prior sanctions for this ingredient 2011] different from the uses established in this section do not exist or have been § 184.1452 Manganese gluconate. waived. (a) Manganese gluconate [50 FR 19165, May 7, 1985, as amended at 76 (C12H22MnO14·2H2O, CAS Reg. No. 648– FR 59250, Sept. 26, 2011] 0953–0998) is a slightly pink colored powder. It is obtained by reacting man- § 184.1449 Manganese citrate. ganese carbonate with gluconic acid in (a) Manganese citrate (Mn3(C6H5O7)2, aqueous medium and then crystallizing CAS Reg. No. 10024–66–5) is a pale or- the product. ange or pinkish white powder. It is ob- (b) The ingredient meets the speci- tained by precipitating manganese car- fications of the Food Chemicals Codex, bonate from manganese sulfate and so- 3d Ed. (1981), p. 186, which is incor- dium carbonate solutions. The filtered porated by reference. Copies are avail- and washed precipitate is digested first able from the National Academy Press, with sufficient citric acid solution to 2101 Constitution Ave. NW., Wash- form manganous citrate and then with ington, DC 20418, or available for in- sodium citrate to complete the reac- spection at the National Archives and tion. Records Administration (NARA). For (b) The ingredient must be of a pu- information on the availability of this rity suitable for its intended use. 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 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. 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 a nutri- current good manufacturing practice: ent supplement as defined in baked goods as defined in § 170.3(n)(1) of § 170.3(o)(20) of this chapter. this chapter; nonalcoholic beverages as (2) The ingredient is used in the fol- defined in § 170.3(n)(3) of this chapter; lowing foods at levels not to exceed dairy product analogs as defined in current good manufacturing practice: § 170.3(n)(10) of this chapter; fish prod- baked goods as defined in § 170.3(n)(1) of

546

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00556 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1472

this chapter; nonalcoholic beverages as the following current good manufac- defined in § 170.3(n)(3) of this chapter; turing practice conditions of use: dairy product analogs as defined in (1) The ingredient is used as a nutri- § 170.3(n)(10) of this chapter; fish prod- ent supplement as defined in ucts as defined in § 170.3(n)(13) of this § 170.3(o)(20) of this chapter. chapter; meat products as defined in (2) The ingredient is used in the fol- § 170.3(n)(29) of this chapter; milk prod- lowing foods at levels not to exceed ucts as defined in § 170.3(n)(31) of this current good manufacturing practice: chapter; and poultry products as de- baked goods as defined in § 170.3(n)(1) of fined in § 170.3(n)(34) of this chapter. this chapter; nonalcoholic beverages as The ingredient may be used in infant defined in § 170.3(n)(3) of this chapter; formulas in accordance with section dairy product analogs as defined in 412(g) of the Federal Food, Drug, and § 170.3(n)(10) of this chapter; fish prod- Cosmetic Act (the act) or with regula- ucts as defined in § 170.3(n(13) of this tions promulgated under section 412(a)(2) of the act. chapter; meat products as defined in § 170.3(n)(29) of this chapter; milk prod- (d) Prior sanctions for this ingredient different from the uses established in ucts as defined in § 170.3(n)(31) of this this section do not exist or have been chapter; and poultry products as de- waived. fined in § 170.3(n)(34) of this chapter. The ingredient may be used in infant [50 FR 19166, May 7, 1985] formulas in accordance with section § 184.1461 Manganese sulfate. 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regula- (a) Manganese sulfate (MnSO4·H2O, tions promulgated under section CAS Reg. No. 7785–0987–097) is a pale 412(a)(2) of the act. pink, granular, odorless powder. It is (d) Prior sanctions for this ingredient obtained by reacting manganese com- different from the uses established in pounds with sulfuric acid. It is also ob- this section do not exist or have been tained as a byproduct in the manufac- waived. ture of hydroquinone. Other manufac- turing processes include the action of [50 FR 19166, May 7, 1985] sulfur dioxide on a slurry of manganese dioxide in sulfuric acid, and the roast- § 184.1472 Menhaden oil. ing of pyrolusite (MnO2) ore with solid (a) Menhaden oil. (1) Menhaden oil is ferrous sulfate and coal, followed by prepared from fish of the genus leaching and crystallization. Brevoortia, commonly known as menha- (b) The ingredient meets the speci- den, by cooking and pressing. The re- fications of the Food Chemicals Codex, sulting crude oil is then refined using 3d Ed. (1981), p. 188, which is incor- the following steps: Storage (winteriza- porated by reference. Copies are avail- tion), degumming (optional), neutral- able from the National Academy Press, ization, bleaching, and deodorization. 2101 Constitution Ave. NW., Wash- Winterization may separate the oil and ington, DC 20418, or available for in- produce a solid fraction. spection at the National Archives and Records Administration (NARA). For (2) Menhaden oil meets the following information on the availability of this specifications: material at NARA, call 202–741–6030, or (i) Color and state. Yellow liquid to go to: http://www.archives.gov/ white solid. federallregister/ (ii) Odor. Odorless to slightly fishy. codeloflfederallregulations/ (iii) Saponification value. Between 180 ibrllocations.html. and 200 as determined by the American (c) In accordance with § 184.1(b)(1), Oil Chemists’ Society Official Method the ingredient is used in food with no Cd 3–25—‘‘Saponification Value’’ (re- limitation other than current good approved 1989), which is incorporated manufacturing practice. The affirma- by reference in accordance with 5 tion of this ingredient as generally rec- U.S.C. 552(a) and 1 CFR part 51. Copies ognized as safe (GRAS) as a direct of this publication are available from human food ingredient is based upon the Office of Food Additive Safety,

547

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00557 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1472 21 CFR Ch. I (4–1–15 Edition)

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. ministration, 5100 Paint Branch Pkwy., (viii) Lead. Not more than 0.1 part College Park, MD 20740, or available for per million as determined by the Amer- inspection at the Center for Food Safe- ican Oil Chemists’ Society Official ty and Applied Nutrition’s Library, Method Ca 18c–91—‘‘Determination of Food and Drug Administration, 5100 Lead by Direct Graphite Furnace Paint Branch Pkwy., College Park, MD Atomic Absorption Spectrometry’’ (re- 20740, or at the National Archives and vised 1992), which is incorporated by Records Administration (NARA). For reference in accordance with 5 U.S.C. information on the availability of this 552(a) and 1 CFR part 51. The avail- material at NARA, call 202–741–6030, or ability of this incorporation by ref- go to: http://www.archives.gov/ erence is given in paragraph (a)(2)(iii) federallregister/ of this section. codeloflfederallregulations/ (ix) Mercury. Not more than 0.5 part ibrllocations.html. per million as determined by the meth- (iv) Iodine number. Not less than 120 od entitled ‘‘Biomedical Test Materials as determined by the American Oil Program: Analytical Methods for the Chemists’ Society Recommended Prac- Quality Assurance of Fish Oil,’’ pub- tice Cd 1d–92—‘‘Iodine Value of Fats lished in the ‘‘NOAA Technical Memo- and Oils, Cyclohexane—Acetic Acid randum NMFS-SEFC-211,’’ F. M. Van Method,’’ which is incorporated by ref- Dolah and S. B. Galloway, editors, Na- erence in accordance with 5 U.S.C. tional Marine Fisheries Service, U. S. 552(a) and 1 CFR part 51. The avail- Department of Commerce, pages 71–88, ability of this incorporation by ref- November, 1988, which is incorporated erence is given in paragraph (a)(2)(iii) by reference in accordance with 5 of this section. U.S.C. 552(a) and 1 CFR part 51. The (v) Unsaponifiable matter. Not more availability of this incorporation by than 1.5 percent as determined by the reference is given in paragraph American Oil Chemists’ Society Offi- (a)(2)(iii) of this section. cial Method Ca 6b–53—‘‘Unsaponifiable (3) In accordance with § 184.1(b)(2), Matter’’ (reapproved 1989), which is in- the ingredient may be used in food only corporated by reference in accordance within the following specific limita- with 5 U.S.C. 552(a) and 1 CFR part 51. tions to ensure that total intake of The availability of this incorporation eicosapentaenoic acid or by reference is given in paragraph docosahexaenoic acid does not exceed (a)(2)(iii) of this section. 3.0 grams/person/day: (vi) Free fatty acids. Not more than 0.1 Maximum percent as determined by the American level of use in Oil Chemists’ Society Official Method Category of food food (as Ca 5a–40—‘‘Free Fatty Acids’’ (re- served) approved 1989), which is incorporated Baked goods, baking mixes, § 170.3(n)(1) of 5.0 percent by reference in accordance with 5 this chapter. Cereals, § 170.3(n)(4) of this chapter ...... 4.0 percent U.S.C. 552(a) and 1 CFR part 51. The Cheese products, § 170.3(n)(5) of this chap- 5.0 percent availability of this incorporation by ter. reference is given in paragraph Chewing gum, § 170.3(n)(6) of this chapter .. 3.0 percent (a)(2)(iii) of this section. Condiments, § 170.3(n)(8) of this chapter ..... 5.0 percent Confections, frostings, § 170.3(n)(9) of this 5.0 percent (vii) Peroxide value. Not more than 5 chapter. milliequivalents per kilogram of oil as Dairy product analogs, § 170.3(n)(10) of this 5.0 percent determined by the American Oil Chem- chapter. Egg products, § 170.3(n)(11) of this chapter 5.0 percent ists’ Society Official Method Cd 8–53— Fats, oils, § 170.3(n)(12) of this chapter, but 12.0 percent ‘‘Peroxide Value, Acetic Acid—Chloro- not in infant formula. form Method’’ (updated 1992) or Rec- Fish products, § 170.3(n)(13) of this chapter 5.0 percent Frozen dairy desserts, § 170.3(n)(20) of this 5.0 percent ommended Practice Cd 8b–90—‘‘Per- chapter. oxide Value, Acetic Acid—Isooctane Gelatins, puddings, § 170.3(n)(22) of this 1.0 percent Method’’ (updated 1992), which are in- chapter. corporated by reference in accordance Gravies, sauces, § 170.3(n)(24) of this chap- 5.0 percent ter. with 5 U.S.C. 552(a) and 1 CFR part 51. Hard candy, § 170.3(n)(25) of this chapter .... 10.0 percent The availability of this incorporation Jams, jellies, § 170.3(n)(28) of this chapter .. 7.0 percent

548

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00558 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1490

Maximum (ix) Mercury. Not more than 0.5 part level of use in Category of food food (as per million. served) (x) Arsenic (as As). Not more than 0.1

Meat products, § 170.3(n)(29) of this chapter 5.0 percent part per million. Milk products, § 170.3(n)(31) of this chapter 5.0 percent (xi) Lead. Not more than 0.1 part per Nonalcoholic beverages, § 170.3(n)(3) of this 0.5 percent million. chapter. Nut products, § 170.3(n)(32) of this chapter .. 5.0 percent (3) Partially hydrogenated and hy- Pastas, § 170.3(n)(23) of this chapter ...... 2.0 percent drogenated menhaden oils are used as Plant protein products, § 170.3(n)(33) of this 5.0 percent edible fats or oils, as defined in chapter. Poultry products, § 170.3(n)(34) of this chap- 3.0 percent § 170.3(n)(12) of this chapter, in food at ter. levels not to exceed current good man- Processed fruit juices, § 170.3(n)(35) of this 1.0 percent chapter. ufacturing practice. Processed vegetable juices, § 170.3(n)(36) 1.0 percent (4) If the fat or oil is fully hydro- of this chapter. genated, the name to be used on the Snack foods, § 170.3(n)(37) of this chapter .. 5.0 percent Soft candy, § 170.3(n)(38) of this chapter ..... 4.0 percent label of a product containing it shall Soup mixes, § 170.3(n)(40) of this chapter ... 3.0 percent include the term ‘‘hydrogenated,’’ or if Sugar substitutes, § 170.3(n)(42) of this 10.0 percent it is partially hydrogenated, the name chapter. Sweet sauces, toppings, syrups, 5.0 percent shall include the term ‘‘partially hy- § 170.3(n)(43) of this chapter. drogenated,’’ in accordance with White granulated sugar, § 170.3(n)(41) of 4.0 percent this chapter. § 101.4(b)(14) of this chapter. [62 FR 30756, June 5, 1997, as amended at 70 (4) To ensure safe use of the sub- FR 14531, Mar. 23, 2005] stance, menhaden oil shall not be used in combination with any other added § 184.1490 Methylparaben. oil that is a significant source of eicosapentaenoic acid or (a) Methylparaben is the chemical docosahexaenoic acid. methyl p-hydroxybenzoate. It is pro- (b) Hydrogenated and partially hydro- duced by the methanol esterification of genated menhaden oils. (1) Partially hy- p-hydroxybenzoic acid in the presence drogenated and hydrogenated menha- of sulfuric acid, with subsequent dis- den oils are prepared by feeding hydro- tillation. gen gas under pressure to a converter (b) The ingredient meets the speci- containing crude menhaden oil and a fications of the ‘‘Food Chemicals nickel catalyst. The reaction is begun Codex,’’ 3d Ed. (1981), p. 199, which is in- at 150 to 160 °C and after 1 hour the corporated by reference. Copies may be temperature is raised to 180 °C until obtained from the National Academy the desired degree of hydrogenation is Press, 2101 Constitution Ave. NW., reached. Hydrogenated menhaden oil is Washington, DC 20418, or may be exam- fully hydrogenated. ined at the National Archives and (2) Partially hydrogenated and hy- Records Administration (NARA). For drogenated menhaden oils meet the fol- information on the availability of this lowing specifications: material at NARA, call 202–741–6030, or (i) Color. Opaque white solid. go to: http://www.archives.gov/ (ii) Odor. Odorless. federal register/ (iii) Saponification value. Between 180 l and 200. codeloflfederallregulations/ (iv) Iodine number. Not more than 119 ibrllocations.html. for partially hydrogenated menhaden (c) The ingredient is used as an anti- oil and not more than 10 for fully hy- microbial agent as defined in drogenated menhaden oil. § 170.3(o)(2) of this chapter. (v) Unsaponifiable matter. Not more (d) The ingredient is used in food at than 1.5 percent.— levels not to exceed good manufac- (vi) Free fatty acids. Not more than 0.1 turing practices. Current good manu- percent. facturing practice results in a max- (vii) Peroxide value. Not more than 5 imum level of 0.1 percent in food. milliequivalents per kilogram of oil. (e) Prior sanctions for this ingredient (viii) Nickel. Not more than 0.5 part different from the uses established in per million.

549

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00559 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1498 21 CFR Ch. I (4–1–15 Edition)

this regulation do not exist or have § 184.1505 Mono- and diglycerides. been waived. (a) Mono- and diglycerides consist of [42 FR 14653, Mar. 15, 1977, as amended at 49 a mixture of glyceryl mono- and FR 5612, Feb. 14, 1984] diesters, and minor amounts of triesters, that are prepared from fats § 184.1498 Microparticulated protein or oils or fat-forming acids that are de- product. rived from edible sources. The most (a) Microparticulated protein product prevalent fatty acids include lauric, is prepared from egg whites or milk linoleic, myristic, oleic, palmitic, and protein or a combination of egg whites stearic. Mono- and diglycerides are and milk protein. These protein manufactured by the reaction of glyc- sources may be used alone or in com- erin with fatty acids or the reaction of bination with other safe and suitable glycerin with triglycerides in the pres- ingredients to form the ence of an alkaline catalyst. The prod- microparticulated product. The mix- ucts are further purified to obtain a ture of ingredients is high-shear heat mixture of glycerides, free fatty acids, processed to achieve a smooth and and free glycerin that contains at least creamy texture similar to that of fat. 90 percent-by-weight glycerides. Safe and suitable ingredients used in (b) The ingredient meets the speci- the preparation of the fications of the Food Chemicals Codex, microparticulated protein product 3d Ed. (1981), p. 201, which is incor- must be used in compliance with the porated by reference in accordance limitations of the appropriate regula- with 5 U.S.C. 552(a). Copies are avail- tions in parts 172, 182, and 184 of this able from the National Academy Press, chapter. 2101 Constitution Ave. NW., Wash- (b) The ingredient is used in food in ington, DC 20418, or available for in- accordance with § 184.1(b)(2) at levels spection at the National Archives and not to exceed current good manufac- Records Administration (NARA). For turing practice. The affirmation of the information on the availability of this use of this ingredient as generally rec- material at NARA, call 202–741–6030, or ognized as safe (GRAS) as a direct go to: http://www.archives.gov/ human food ingredient is based upon federallregister/ the following conditions of use: codeloflfederallregulations/ (1) The ingredient is used in food as a ibrllocations.html. (c) In accordance with § 184.1(b)(1), thickener as defined in § 170.3(o)(28) of the ingredient is used in food with no this chapter or as a texturizer as de- limitation other than current good fined in § 170.3(o)(32) of this chapter. manufacturing practice. The affirma- (2) The ingredient is used in frozen tion of this ingredient as generally rec- dessert-type products except that the ognized as safe (GRAS) as a direct ingredient may not be used to replace human food ingredient is based upon the milk fat required in standardized the following current good manufac- frozen desserts. turing practice conditions of use: (3) The name of the ingredient used (1) The ingredient is used in food as a in the ingredient statement on both dough strengthener as defined in bulk and packaged food must include § 170.3(o)(6) of this chapter; an emulsi- the source of the protein (e.g., fier and emulsifier salt as defined in ‘‘microparticulated egg white pro- § 170.3(o)(8) of this chapter; a flavoring tein’’), followed by a parenthetical list- agent and adjuvant as defined in ing of each of the ingredients in the § 170.3(o)(12) of this chapter; a formula- microparticulated protein product, in tion aid as defined in § 170.3(o)(14) of descending order of predominance. this chapter; a lubricant and release Microparticulated protein product agent as defined in § 170.3(o)(18) of this must be used in accordance with this chapter; a solvent and vehicle as de- requirement or its addition to food will fined in § 170.3(o)(27) of this chapter; a be considered by FDA to constitute the stabilizer and thickener as defined in use of an unapproved food additive (see § 170.3(o)(28) of this chapter; a surface- § 184.1(b)(2)). active agent as defined in § 170.3(o)(29) [55 FR 6391, Feb. 23, 1990] of this chapter; a surface-finishing

550

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00560 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1535

agent as defined in § 170.3(o)(30) of this pyridinecarboxylic acid (nicotinic chapter; and a texturizer as defined in acid). It is a non-hygroscopic, stable, § 170.3(o)(32) of this chapter. white, crystalline solid that sublimes (2) The ingredient is used in food at without decomposition at about 230 °C. levels not to exceed current good man- It is soluble in water and alcohol. It is ufacturing practice. insoluble in ether. (d) Prior sanctions for this ingredient (b) The ingredient meets the speci- different from the uses established in fications of the ‘‘Food Chemicals this section do not exist or have been Codex,’’ 4th ed. (1996), p. 264, which is waived. incorporated by reference in accord- ance with 5 U.S.C. 552(a) and 1 CFR [54 FR 7403, Feb. 21, 1989, as amended at 57 FR 10616, Mar..27, 1992] part 51. Copies are available from the National Academy Press, Box 285, 2101 § 184.1521 Monosodium phosphate de- Constitution Ave. NW., Washington, rivatives of mono- and diglycerides. DC 20055 (Internet address http:// (a) Monosodium phophate derivatives www.nap.edu), or may be examined at of mono- and diglycerides are com- the Center for Food Safety and Applied posed of glyceride derivatives formed Nutrition’s Library, Food and Drug Ad- by reacting mono- and diglycerides ministration, 5100 Paint Branch Pkwy., that are derived from edible sources College Park, MD 20740, or at the Na- with phosphorus pentoxide tional Archives and Records Adminis- (tetraphosphorus decoxide) followed by tration (NARA). For information on neutralization with sodium carbonate. the availability of this material at (b) The ingredient must be of a pu- NARA, call 202–741–6030, or go to: http:// rity suitable for its intended use. 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 generally rec- the following current good manufac- ognized as safe (GRAS) as direct turing practice conditions of use: human food ingredient is based upon (1) The ingredient is used in food as the following current good manufac- an emulsifier and emulsifier salt as de- turing practice conditions of use: fined in § 170.3(o)(8) of this chapter, a (1) The ingredient is used as a nutri- lubricant and release agent as defined ent supplement as defined in in § 170.3(o)(18) of this chapter, and as a § 170.3(o)(20) of this chapter. surface-active agent as defined in (2) The ingredient is used in foods at § 170.3(o)(29) 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 dairy product analogs as defined in Federal Food, Drug, and Cosmetic Act § 170.3(n)(10) of this chapter and soft (the Act) or with regulations promul- candy as defined in § 170.3(n)(38) of this gated under section 412(a)(2) of the Act. chapter. (d) 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. [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. [54 FR 7404, Feb. 21, 1989, as amended at 73 2, 1983, as amended at 64 FR 1760, Jan. 12, FR 8607, Feb. 14, 2008] 1999]

§ 184.1530 Niacin. § 184.1535 Niacinamide.

(a) Niacin (C6H5NO2, CAS Reg. No. 59– (a) Niacinamide (C6H6N2O, CAS Reg. 67–6) is the chemical 3- No. 98–92–0) is the chemical 3-

551

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00561 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1537 21 CFR Ch. I (4–1–15 Edition)

pyridinecarboxylic acid amide (nicotin- limitation other than current good amide). It is a white crystalline powder manufacturing practice. The affirma- that is soluble in water, alcohol, ether, tion of this ingredient as generally rec- and glycerol. It melts between 128° and ognized as safe (GRAS) as a direct 131 °C. human food ingredient is based upon (b) The ingredient meets the speci- the following current good manufac- fications of the Food Chemicals Codex, turing practice conditions of use: 3d Ed. (1981), p. 205, which is incor- (1) The ingredient is used as a cata- porated by reference. Copies are avail- lyst as defined in § 170.3(o)(24) of this able from the National Academy Press, chapter. 2101 Constitution Ave. NW., Wash- (2) The ingredient is used in the hy- ington, DC 20418, or available for in- drogenation of fats and oils as defined spection at the National Archives and in § 170.3(n)(12) of this chapter at levels Records Administration (NARA). For not to exceed current good manufac- information on the availability of this turing practice. Current good manufac- material at NARA, call 202–741–6030, or turing practice includes the removal of go to: http://www.archives.gov/ nickel from fats and oils following hy- federallregister/ drogenation. 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 do not exist or have been the ingredient is used in food with no waived. limitation other than current good manufacturing practice. The affirma- [48 FR 51618, Nov. 10, 1983, as amended at 73 tion of this ingredient as generally rec- FR 8607, Feb. 14, 2008] ognized as safe (GRAS) as a direct human food ingredient is based upon § 184.1538 Nisin preparation. the following current good manufac- (a) Nisin preparation is derived from turing practice conditions of use: pure culture fermentations of certain (1) The ingredient is used as a nutri- strains of Streptococcus lactis ent supplement as defined in Lancefield Group N. Nisin preparation § 170.3(o)(20) of this chapter. contains nisin (CAS Reg. No. 1414–45–5), (2) The ingredient is used in foods at a group of related peptides with anti- levels not to exceed current good man- biotic activity. ufacturing practice. The ingredient (b) The ingredient is a concentrate or may also be used in infant formula in dry material that meets the specifica- accordance with section 412(g) of the tions that follow when it is tested as Federal Food, Drug, and Cosmetic Act described in ‘‘Specifications for Iden- (the act) or with regulations promul- tity and Purity of Some Antibiotics,’’ gated under section 412(a)(2) of the Act. World Health Organization, FAO Nutri- (d) Prior sanctions for this ingredient tion Meeting Report Series, No. 45A, different from the uses established in 1969, which is incorporated by ref- this section do not exist or have been erence. Copies are available from the waived. Division of Dockets Management [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. (HFA–305), Food and Drug Administra- 2, 1983] tion, 5630 Fishers Lane, rm. 1061, Rock- ville, MD 20852, or available for inspec- § 184.1537 Nickel. tion at the National Archives and (a) Elemental nickel (CAS Reg. No. Records Administration (NARA). For 7440–02–0) is obtained from nickel ore information on the availability of this by transforming it to nickel sulfide material at NARA, call 202–741–6030, or (Ni3S2). The sulfide is roasted in air to go to: http://www.archives.gov/ give nickel oxide (NiO). The oxide is federallregister/ then reduced with carbon to give ele- codeloflfederallregulations/ mental nickel. ibrllocations.html. (b) The ingredient must be of a pu- (1) Nisin content, not less than 900 rity suitable for its intended use. international units per milligram. (c) In accordance with § 184.1(b)(1), (2) Arsenic, not more than 1 part per the ingredient is used in food with no million.

552

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00562 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1545

(3) Lead, not more than 2 parts per odorless, flavorless gas that is pro- million. duced commercially by the fraction- (4) Zinc, not more than 25 parts per ation of liquid air. million. (b) The ingredient must be of a pu- (5) Copper, zinc plus copper not more rity suitable for its intended use. than 50 parts per million. (c) In accordance with § 184.1(b)(1), (6) Total plate count, not more than the ingredient is used in food with no 10 per gram. limitations other than current good (7) Escherichia coli, absent in 10 manufacturing practice. The affirma- grams. tion of this ingredient as generally rec- (8) Salmonella, absent in 10 grams. ognized as safe (GRAS) as a direct (9) Coagulase positive staphylococci, human food ingredient is based upon absent in 10 grams. the following current good manufac- (c) The ingredient is used as an anti- turing practice conditions of use: microbial agent as defined in (1) The ingredient is used as a propel- § 170.3(o)(2) of this chapter to inhibit lant, aerating agent, and gas as defined the outgrowth of Clostridium botulinum in § 170.3(o)(25) of this chapter. spores and toxin formation in pasteur- (2) The ingredient is used in food at ized cheese spreads and pasteurized levels not to exceed current good man- process cheese spreads listed in ufacturing practice. § 133.175; pasteurized cheese spread with (d) Prior sanctions for this ingredient fruits, vegetables, or meats as defined different from the uses established in in § 133.176; pasteurized process cheese this section do not exist or have been spread as defined in § 133.179; pasteur- waived. ized process cheese spread with fruits, [48 FR 57270, Dec. 29, 1983, as amended at 73 vegetables, or meats as defined in FR 8607, Feb. 14, 2008] § 133.180 of this chapter. (d) The ingredient is used at levels § 184.1545 Nitrous oxide. not to exceed good manufacturing (a) Nitrous oxide (empirical formula practice in accordance with § 184.1(b)(1) N2O, CAS Reg. No. 10024–97–2) is also of this chapter. The current good man- known as dinitrogen monoxide or ufacturing practice level is the quan- laughing gas. It is a colorless gas, tity of the ingredient that delivers a about 50 percent heavier than air, with maximum of 250 parts per million of a slightly sweet smell. It does not burn nisin in the finished product as deter- but will support combustion. Nitrous mined by the British Standards Insti- oxide is manufactured by the thermal tution Methods, ‘‘Methods for the Esti- decomposition of ammonium nitrate. mation and Differentiation of Nisin in Higher oxides of nitrogen are removed Processed Cheese,’’ BS 4020 (1974), by passing the dry gas through a series which is incorporated by reference. of scrubbing towers. Copies are available from the Division (b) The ingredient must be of a pu- of Dockets Management (HFA–305), rity suitable for its intended use. Food and Drug Administration, rm. 1– (c) In accordance with § 184.1(b)(1), 23, 12420 Parklawn Dr., Rockville, MD the ingredient is used in food with no 20857, or available for inspection at the limitations other than current good National Archives and Records Admin- manufacturing practice. The affirma- istration (NARA). For information on tion of this ingredient as generally rec- the availability of this material at ognized as safe (GRAS) as a direct NARA, call 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 propel- [53 FR 11250, Apr. 6, 1988, as amended at 59 lant, aerating agent, and gas as defined FR 14364, Mar. 28, 1994; 68 FR 24879, May 9, in § 170.3(o)(25) of this chapter. 2003] (2) The ingredient is used in dairy product analogs as defined in § 184.1540 Nitrogen. § 170.3(n)(10) of this chapter at levels (a) Nitrogen (empirical formula N2, not to exceed current good manufac- CAS Reg. No. 7727–37–9) is a colorless, turing practice.

553

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00563 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1553 21 CFR Ch. I (4–1–15 Edition)

(d) Prior sanctions for this ingredient which result from the full hydro- different from the uses established in genation of fatty acids occurring in this section do not exist or have been natural rapeseed oil. The rapeseed oil waived. is obtained from the napus and campestris varieties of Brassica of the [48 FR 57270, Dec. 29, 1983, as amended at 73 FR 8607, Feb. 14, 2008] family Cruciferae. It is prepared by fully hydrogenating refined and § 184.1553 Peptones. bleached rapeseed oil at 310–375 °F, using a catalyst such as nickel, until (a) Peptones are a variable mixture the iodine number is 4 or less. of polypeptides, oligopeptides, and (2) The ingredient meets the fol- amino acids that are produced by par- lowing specifications: Acid value not tial hydrolysis of casein, animal tissue, more than 6, arsenic not more than 3 soy protein isolate, gelatin, defatted parts per million, free glycerin not fatty tissue, egg albumin, or lactal- more than 7 percent, heavy metals (as bumin (whey protein). Peptones are Pb) not more than 10 parts per million, produced from these proteins using iodine number not more than 4, residue proteolytic enzymes that either are on ignition not more than 0.5 percent. considered to be generally recognized (3) The ingredient is used as a sta- as safe (GRAS) or are regulated as food bilizer and thickener as defined in additives. Peptones are also produced § 170.3(o)(28) of this chapter in peanut by denaturing any of the proteins list- butter. The use level of the ingredient ed in this paragraph with safe and suit- is limited by good manufacturing prac- able acids or heat. tice (GMP) to the minimum amount re- (b) The ingredients must be of a pu- quired to produce the intended effect. rity suitable for their intended use. Current good manufacturing practices (c) In accordance with § 184.1(b)(1), result in a maximum level of 2 percent these ingredients are used in food with in peanut butter. no limitation other than current good (b) Superglycerinated fully hydro- manufacturing practice. The affirma- genated rapeseed oil. (1) tion of these ingredients as GRAS as Superglycerinated fully hydrogenated direct human food ingredients is based rapeseed oil is a mixture of mono- and upon the following current good manu- diglycerides with triglycerides as a facturing practice conditions of use: minor component. The fatty acid com- (1) These ingredients are used as nu- position is a mixture of saturated fatty trient supplements as defined in acids present in the same proportions § 170.3(o)(20) of this chapter; as proc- as those resulting from the full hydro- essing aids as defined in § 170.3(o)(24) of genation of fatty acids in natural this chapter; and as surface-active rapeseed oil. It is made by adding ex- agents as defined in § 170.3(o)(29) of this cess glycerol to the fully hydrogenated chapter. rapeseed oil and heating, in the pres- (2) These ingredients are used in food ence of a sodium hydroxide catalyst, to at levels not to exceed current good 330 °F under partial vacuum and steam manufacturing practice. sparging agitation. (d) Prior sanctions for these ingredi- (2) The ingredient meets the speci- ents different from the uses established fications of the ‘‘Food Chemicals in this section do not exist or have Codex,’’ 3d Ed. (1981), p. 201, relating to been waived. mono- and diglycerides, which is incor- [49 FR 25430, June 21, 1984, as amended at 50 porated by reference. Copies may be FR 49536, Dec. 3, 1985; 73 FR 8607, Feb. 14, obtained from the National Academy 2008] Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be exam- § 184.1555 Rapeseed oil. ined at the National Archives and (a) Fully hydrogenated rapeseed oil. (1) Records Administration (NARA). For Fully hydrogenated rapeseed oil is a information on the availability of this mixture of triglycerides in which the material at NARA, call 202–741–6030, or fatty acid composition is a mixture of go to: http://www.archives.gov/ saturated fatty acids. The fatty acids federallregister/ are present in the same porportions codeloflfederallregulations/

554

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00564 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1563

ibrllocations.html. An additional speci- § 184.1560 Ox bile extract. fication requires the iodine number to (a) Ox bile extract (CAS Reg. No. be 4 or less. 8008–63–7), also known as purified (3) The ingredient is used as an emul- oxgall or sodium choleate, is a yel- sifier as defined in § 170.3(o)(8) of this lowish green, soft solid, with a partly chapter in shortenings for cake mixes. sweet, partly bitter, disagreeable taste. The use level of the ingredient is lim- It is the purified portion of the bile of ited by good manufacturing practice an ox obtained by evaporating the alco- (GMP) to the minimum amount re- hol extract of concentrated bile. quired to produce the intended effect. (b) Food-grade ox bile extract shall Current good manufacturing practices meet the specifications of the U.S. result in a maximum level, as served, Pharmacopeia (USP), XIV, 1950, p. 410. 1 of 4 percent of the shortening or 0.5 (c) The ingredient is used as a surfac- percent of the total weight of the cake tant as defined in § 170.3 (o)(29) of this mix. chapter. (c) Low erucic acid rapeseed oil. (1) (d) The ingredient is used in food in Low erucic acid rapeseed oil, also accordance with § 184.1(b)(1) at levels known as canola oil, is the fully re- not to exceed good manufacturing fined, bleached, and deodorized edible practice. Current good manufacturing oil obtained from certain varieties of practice results in a maximum level, as Brassica Napus or B. Campestris of the served, of 0.002 percent for cheese as de- family Cruciferae. The plant varieties fined in § 170.3(n)(5) of this chapter. are those producing oil-bearing seeds (e) Prior sanctions for this ingredient with a low erucic acid content. Chemi- different from the uses established in cally, low erucic acid rapeseed oil is a this section do not exist or have been mixture of triglycerides, composed of waived. both saturated and unsaturated fatty acids, with an erucic acid content of no [43 FR 36064, Aug. 15, 1978. Redesignated and more than 2 percent of the component amended at 50 FR 49537, Dec. 3, 1985] fatty acids. (2) Low erucic acid rapeseed oil as de- § 184.1563 Ozone.

fined in paragraph (c)(1) of this section (a) Ozone (O3, CAS Reg. No. 10028–15– may be partially hydrogenated to re- 6) is an unstable blue gas with a pun- duce the proportion of unsaturated gent, characteristic odor, which occurs fatty acids. When the partially hydro- freely in nature, It is produced com- genated low erucic acid rapeseed oil is mercially by passing electrical dis- used, it shall be referred to as partially charges or ionizing radiation through hydrogenated low erucic acid rapeseed air or oxygen. oil. (b) The ingredient must be of a pu- (3) In addition to limiting the con- rity suitable for its intended use in ac- tent of erucic acid to a level not ex- cordance with § 170.30(h)(1) of this chap- ceeding 2 percent of the component ter. fatty acids, low erucic acid rapeseed oil (c) In accordance with § 184.1(b)(2), and partially hydrogenated low erucic the ingredient is used to treat food acid rapeseed oil must be of a purity only within the following specific limi- suitable for their intended use. tations: (4) Low erucic acid rapeseed oil and partially hydrogenated low erucic acid rapeseed oil are used as edible fats and oils in food, except in infant formula, at levels not to exceed current good manufacturing practice. [42 FR 48336, Sept. 23, 1977, as amended at 49 FR 5613, Feb. 14, 1984; 50 FR 3755, Jan. 28, 1 Copies may be obtained from: U.S. 1985; 53 FR 52682, Dec. 29, 1988; 73 FR 8608, Pharmacopeial Convention, Inc., 12601 Feb. 14, 2008] Twinbrook Parkway, Rockville, MD 20852.

555

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00565 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1583 21 CFR Ch. I (4–1–15 Edition)

(2) The ingredient is used in food at Category of food Maximum treat- Functional use ment level in food levels not to exceed current good man- Bottled water that Not to exceed cur- Antimicrobial ufacturing practice. prior to ozonation rent good man- agent, § 170.3 meets the micro- ufacturing prac- (o)(2) of this [60 FR 32911, June 26, 1995, as amended at 78 biological, phys- tice. Current chapter. FR 14666, Mar. 7, 2013] ical, chemical, good manufac- and radiological turing practice § 184.1585 Papain. quality standards results in a of § 165.110 maximum resid- (a) Papain (CAS Reg. No. 9001–73–4) is (b)(2) through ual level at the a proteolytic enzyme derived from (b)(5) of this time of bottling chapter. of 0.4 milligram Carica papaya L. Crude latex con- of ozone per taining the enzyme is collected from liter of bottled slashed unripe papaya. The food-grade water. product is obtained by repeated filtra- tion of the crude latex or an aqueous [47 FR 50210, Nov. 5, 1982, as amended at 60 solution of latex or by precipitation FR 57130, Nov. 13, 1995] from an aqueous solution of latex. The § 184.1583 Pancreatin. resulting enzyme preparation may be used in a liquid or dry form. (a) Pancreatin (CAS Reg. No. 8049–47– (b) The ingredient meets the speci- 6) is an enzyme preparation obtained fications of the Food Chemicals Codex, from porcine or bovine pancreatic tis- 3d Ed. (1981), pp. 107–110, which is incor- sue. It is a white to tan powder. Its porated by reference. Copies are avail- characterizing enzyme activity that of a peptide hydrolase (EC 3.4.21.36). able from the National Academy Press, 2101 Constitution Ave. NW., Wash- (b) The ingredient meets the general requirements and additional require- ington, DC 20418, or available for in- ments in the Food Chemicals Codex, 3d spection at the National Archives and ed. (1981), p. 110, which is incorporated Records Administration (NARA). For by reference in accordance with 5 information on the availability of this U.S.C. 552(a) and 1 CFR part 51. Copies material at NARA, call 202–741–6030, or are available from the National Acad- go to: http://www.archives.gov/ emy Press, 2101 Constitution Ave. NW., federallregister/ Washington, DC 20418, or may be exam- codeloflfederallregulations/ ined at the Office of Food Additive ibrllocations.html. Safety (HFS–200), Center for Food Safe- (c) In accordance with § 184.1(b)(1), ty and Applied Nutrition, Food and the ingredient is used in food with no Drug Administration, 5100 Paint limitation other than currect good Branch Pkwy., College Park, MD 20740, manufacturing practice. The affirma- 240–402–1200, and at the National Ar- tion of this ingredient as generally rec- chives and Records Administration ognized as safe (GRAS) as a direct (NARA). For information on the avail- human food ingredient is based upon ability of this material at NARA, call the following current good manufac- 202–741–6030, or go to: http:// turing conditions of use: www.archives.gov/federallregister/ (1) The ingredient is used as an en- codeloflfederallregulations/ zyme as defined in § 170.3(o)(9) of this ibrllocations.html. chapter; processing aid as defined in (c) In accordance with § 184.1(b)(1), § 170.3(o)(24) of this chapter; and the ingredient is used in food with no texturizer as defined in § 170.3(o)(32) of limitation other than current good this chapter. manufacturing practice. The affirma- (2) The ingredient is used in food at tion of this ingredient as GRAS as a di- levels not to exceed current good man- rect food ingredient is based upon the ufacturing practice. following current good manufacturing (d) Prior sanctions for this ingredient practice conditions of use: different from the uses established in (1) The ingredient is used as an en- this section do not exist or have been zyme as defined in § 170.3(o)(9) of this waived. chapter to hydrolyze proteins or polypeptides. [48 FR 48806, Oct. 21, 1983]

556

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00566 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1595

§ 184.1588 Pectins. (d) Prior sanctions for these ingredi- (a) The pectins (CAS Reg. No. 9000– ents different from the uses established 69–5) are a group of complex, high mo- in this section do not exist or have lecular weight polysaccharides found been waived. in plants and composed chiefly of par- [48 FR 51149, Nov. 7, 1983] tially methylated polygalacturonic acid units. Portions of the carboxly § 184.1595 Pepsin. group occur as methyl esters, and the remaining carboxyl groups exist in the (a) Pepsin (CAS Reg. No. 9001–75–6) is form of the free acid or as its ammo- an enzyme preparation obtained from nium, potassium, or sodium (CAS Reg. the glandular layer of hog stomach. It No. 9000–59–8) salts, and in some types is a white to light tan powder, amber as the acid amide. Thus, the pectins paste, or clear amber to brown liquid. regulated in this section are the high- Its characterizing enzyme activity is ester pectins, low-ester pectins, that of a peptide hydrolase (EC amidated pectins, pectinic acids, and 3.4.23.1). pectinates. Pectin is produced commer- (b) The ingredient meets the general cially by extracting citrus peel, apple requirements and additional require- pomace, or beet pulp with hot dilute ments for enzyme preparations in the acid (pH 1.0 to 3.5, 70° to 90 °C). The ex- Food Chemicals Codex, 3d ed. (1981), p. tract is filtered, and pectin is then pre- 110, which is incorporated by reference cipitated from the clear extract with in accordance with 5 U.S.C. 552(a) and 1 ethanol or isopropanol, or as the cop- CFR part 51. Copies are available from per or aluminum salt. The acid extract the National Academy Press, 2101 Con- is sometimes spray- or roller-dried, or it is concentrated to be sold as liquid stitution Ave. NW., Washington, DC pectin. 20418, or may be examined at the Office (b) The ingredients meet the speci- of Food Additive Safety (HFS–200), fications of the Food Chemical Codex, Center for Food Safety and Applied Nu- 3d Ed. (1981), p. 215, which is incor- trition, Food and Drug Administration, porated by reference. Copies are avail- 5100 Paint Branch Pkwy., College Park, able from the National Academy Press, MD 20740, 240–402–1200, and at the Na- 2101 Constitution Ave. NW., Wash- tional Archives and Records Adminis- ington, DC 20418, or available for in- tration (NARA). For information on spection at the National Archives and the availability of this material at Records Administration (NARA). For NARA, call 202–741–6030, or go to: http:// information on the availability of this www.archives.gov/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 ingredients are used in food with tion of this ingredient as GRAS as a di- no limitation other than current good rect food ingredient is based upon the manufacturing practice. The affirma- tion of these ingredients as generally following current good manufacturing recognized as safe (GRAS) as direct practice conditions of use: human food ingredients is based upon (1) The ingredient is used as an en- the following current good manufac- zyme as defined in § 170.3(o)(9) of this turing practice conditions of use: chapter to hydrolyze proteins or (1) The ingredients are used as emul- polypeptides. sifiers as defined in § 170.3(o)(8) of this (2) The ingredient is used in food at chapter and as stabilizers and thick- levels not to exceed current good man- eners as defined in § 170.3(o)(28) of this ufacturing practice. chapter. (2) The ingredients are used in food [60 FR 32911, June 26, 1995, as amended at 78 at levels not to exceed current good FR 14667, Mar. 7, 2013] manufacturing practice.

557

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00567 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1610 21 CFR Ch. I (4–1–15 Edition)

§ 184.1610 Potassium alginate. (b) The ingredient meets the speci- fications of the Food Chemicals Codex, (a) Potassium alginate (CAS Reg. No. 3d Ed. (1981), p. 239, which is incor- 9005–36–1) is the potassium salt of al- porated by reference. Copies are avail- ginic acid, a natural polyuronide con- able from the National Academy Press, stituent of certain brown algae. Potas- 2101 Constitution Ave. NW., Wash- sium alginate is prepared by the neu- ington, DC 20418, or available for in- tralization of purified alginic acid with spection at the National Archives and appropriate pH control agents. 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. 239, 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)(2), (1) The ingredient is used as a formu- the ingredient is used in food only lation aid as defined in § 170.3(o)(14) of within the following specific limita- this chapter; nutrient supplemlent as tions: defined in § 170.3(o)(20) of this chapter; Maximum pH control agent as defined in level of § 170.3(o)(23) of this chapter; and proc- use in Category of food food (as Functional use essing aid as defined in § 170.3(o)(24) of served) this chapter. (percent) (2) The ingredient is used in food at Confections and 0.1 Stabilizer, thickener, levels not to exceed current good man- frostings, § 170.3(o)(28) of this ufacturing practice. § 170.3(n)(9) of this chapter chapter. (d) Prior sanctions for this ingredient Gelatins and puddings, 0.7 Do. different from the uses established in § 170.3(n)(22) of this this section do not exist or have been chapter. Processed fruits and 0.25 Do. waived. fruit juices, [48 FR 52442, Nov. 18, 1983] § 170.3(n)(35) of this chapter. All other food cat- 0.01 Do. § 184.1619 Potassium carbonate. egories. (a) Potassium carbonate (K2CO3, CAS (d) Prior sanctions for potassium al- Reg. No. 584–08–7) is produced by the ginate different from the uses estab- following methods of manufacture: lished in this section do not exist or (1) By electrolysis of potassium chlo- have been waived. ride followed by exposing the resultant potassium to carbon dioxide; [47 FR 29951, July 9, 1982] (2) By treating a solution of potas- sium hydroxide with excess carbon di- § 184.1613 Potassium bicarbonate. oxide to produce potassium carbonate; (a) Potassium bicarbonate (KHCO3, (3) By treating a solution of potas- CAS Reg. No. 298–14–6) is made by the sium hydroxide with carbon dioxide to following processes: produce potassium bicarbonate, which (1) By treating a solution of potas- is then heated to yield potassium car- sium hydroxide with carbon dioxide; bonate. (2) By treating a solution of potas- (b) The ingredient meets the speci- sium carbonate with carbon dioxide. fications of the Food Chemicals Codex,

558

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00568 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1625

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 Records Administration (NARA). For manufacturing practice. The affirma- information on the availability of this tion of this ingredient as generally rec- material at NARA, call 202–741–6030, or ognized as safe (GRAS) as a direct go to: http://www.archives.gov/ human food ingredient is based upon federallregister/ the following current good manufac- codeloflfederallregulations/ turing practice conditions of use: ibrllocations.html. (1) The ingredient is used as a flavor (c) In accordance with § 184.1(b)(1), enhancer as defined in § 170.3(o)(11) of the ingredient is used in food with no this chapter; as a flavoring agent as de- limitation other than current good fined in § 170.3(o)(12) of this chapter; as manufacturing practice. the affirma- a nutrient supplement as defined in tion of this ingredient as generally rec- § 170.3(o)(20) of this chapter; as a pH ognized as safe (GRAS) as a direct control agent as defined in § 170.3(o)(23) human food ingredient is based upon of this chapter; and as a stabilizer or the following current good manufac- thickener as defined in § 170.3(o)(28) of turing practice conditions of use: this chapter. (1) The ingredient is used in food as a (2) The ingredient is used in food at flavoring agent and adjuvant as defined levels not to exceed current good man- in § 170.3(o)(12) of this chapter; nutrient ufacturing practice. Potassium chlo- supplement as defined in § 170.3(o)(20) of ride may be used in infant formula in this chapter; pH control agent as de- accordance with section 412(g) of the fined in § 170.3(o)(23) of this chapter; Federal Food, Drug, and Cosmetic Act and processing aid as defined in (the Act) or with regulations promul- § 170.3(o)(24) of this chapter. gated under section 412(a)(2) of the Act. (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 51614, Nov. 10, 1983] this section do not exist or have been waived. § 184.1625 Potassium citrate.

[48 FR 52442, Nov. 18, 1983] (a) Potassium citrate (C6H5K3O7·H2O, CAS Reg. No. 006100–0905–096) is the po- § 184.1622 Potassium chloride. tassium salt of citric acid. It is pre- (a) Potassium chloride (KCl, CAS pared by neutralizing citric acid with Reg. No. 7447–40–7) is a white, odorless potassium hydroxide or potassium car- solid prepared from source minerals by bonate. It occurs as transparent crys- fractional crystallization or flotation. tals or a white granular powder, is It is soluble in water and glycerol and odorless and deliquescent, and contains has a saline taste at low concentration one mole of water per mole of potas- levels. sium citrate. (b) The ingredient meets the speci- (b) The ingredient meets the speci- fications of the Food Chemicals Codex, fications of the Food Chemicals Codex, 3d Ed. (1981), p. 241, which is incor- 3d ed. (1981), p. 242, which is incor- porated by reference. Copies are avail- porated by reference in accordance able from the National Academy Press, with 5 U.S.C. 552(a) and 1 CFR part 51. 2101 Constitution Ave. NW., Wash- Copies are available from the National ington, DC 20418, or available for in- Academy Press, 2101 Constitution Ave. spection at the National Archives and NW., Washington, DC 20418, and the Records Administration (NARA). For Center for Food Safety and Applied Nu- information on the availability of this trition (HFS–200), 5100 Paint Branch material at NARA, call 202–741–6030, or Pkwy., College Park, MD 20740, or may go to: http://www.archives.gov/ be examined at the National Archives

559

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00569 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1631 21 CFR Ch. I (4–1–15 Edition)

and Records Administration (NARA). of this chapter; and a stabilizer and For information on the availability of thickener as defined in § 170.3(o)(28) of this material at NARA, call 202–741– this chapter. 6030, or 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. 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. (d) Prior sanctions for this ingredient [48 FR 52444, Nov. 18, 1983] different from the uses established in § 184.1634 Potassium iodide. this section, or different from those set forth in part 181 of this chapter, do not (a) Potassium iodide (KI, CAS Reg. exist or have been waived. No. 7681–11–0) is the potassium salt of hydriodic acid. It occurs naturally in [59 FR 63896, Dec. 12, 1994] sea water and in salt deposits, but can § 184.1631 Potassium hydroxide. be prepared by reacting hydriodic acid (HI) with potassium bicarbonate (a) Potassium hydroxide (KOH, CAS (KHCO3). Reg. No. 1310–58–3) is also known as (b) The ingredient meets the speci- caustic potash, potash lye, and potassa. fications of the ‘‘Food Chemicals The empirical formula is KOH. It is a Codex,’’ 3d Ed. (1981), pp. 246–247, which white, highly deliquescent caustic is incorporated by reference. Copies solid, which is marketed in several may be obtained from the National forms, including pellets, flakes, sticks, Academy Press, 2101 Constitution Ave. lumps, and powders. Potassium hydrox- NW., Washington, DC 20418, or may be ide is obtained commercially from the examined at the National Archives and electrolysis of potassium chloride solu- Records Administration (NARA). For tion in the presence of a porous dia- information on the availability of this phragm. 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), which is incorporated by codeloflfederallregulations/ reference. Copies are available from ibrllocations.html. the National Academy Press, 2101 Con- (c) The ingredient is used as a nutri- stitution Ave. NW., Washington, DC ent supplement as defined in 20418, or available from inspection at the National Archives and Records Ad- § 170.3(o)(20) of this chapter. ministration (NARA). For information (d) The ingredient is used in table on the availability of this material at salt in accordance with § 184.1(b)(2) of NARA, call 202–741–6030, or go to: http:// this chapter as a source of dietary io- www.archives.gov/federallregister/ dine at a maximum level of 0.01 per- codeloflfederallregulations/ cent. ibrllocations.html. (e) 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- [43 FR 11699, Mar. 21, 1978, as amended at 49 tion of this ingredient as generally rec- FR 5613, Feb. 14, 1984; 61 FR 14247, Apr. 1, ognized as safe (GRAS) as a direct 1996] human food ingredient is based upon the following current good manufac- § 184.1635 Potassium iodate. turing practice conditions of use: (a) Potassium iodate (KIO3, CAS Reg. (1) The ingredient is used as a formu- No. 7758–05–6) does not occur naturally lation aid as defined in § 170.3(o)(14) of but can be prepared by reacting iodine this chapter; a pH control agent as de- with potassium hydroxide. fined in § 170.3(o)(23) of the chapter; a (b) The ingredient meets the speci- processing aid as defined in § 170.3(o)(24) fications of the ‘‘Food Chemicals

560

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00570 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1655

Codex,’’ 3d Ed. (1981), pp. 245–246, which (d) 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 [52 FR 10886, Apr. 6, 1987, as amended at 73 examined at the National Archives and FR 8608, Feb. 14, 2008] Records Administration (NARA). For information on the availability of this § 184.1643 Potassium sulfate. material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ (a) Potassium sulfate (K2SO4, CAS federallregister/ Reg. No. 7778–80–5) occurs naturally and codeloflfederallregulations/ consists of colorless or white crystals ibrllocations.html. or crystalline powder having a bitter, (c) The ingredient is used as a dough saline taste. It is prepared by the neu- strengthener as defined in § 170.3(o)(6) tralization of sulfuric acid with potas- of this chapter. sium hydroxide or potassium car- (d) The ingredient is used in the man- bonate. ufacture of bread in accordance with (b) The ingredient meets the speci- § 184.1(b)(2) of this chapter in an fications of the ‘‘Food Chemicals amount not to exceed 0.0075 percent Codex,’’ 3d Ed. (1981), p. 252, which is in- based on the weight of the flour. corporated by reference. Copies may be (e) Prior sanctions for this ingredient obtained from the National Academy different from the uses established in Press, 2101 Constitution Ave. NW., this section do not exist or have been Washington, DC 20418, or may be exam- waived. ined at the National Archives and Records Administration (NARA). For [43 FR 11699, Mar. 21, 1978, as amended at 49 information on the availability of this FR 5613, Feb. 14, 1984] material at NARA, call 202–741–6030, or § 184.1639 Potassium lactate. go to: http://www.archives.gov/ federallregister/ (a) Potassium lactate (C3H5O3K, CAS codeloflfederallregulations/ Reg. No. 996–31–6) is the potassium salt ibrllocations.html. of lactic acid. It is a hydroscopic, (c) The ingredient is used as a fla- white, odorless solid and is prepared voring agent and adjuvant as defined in commercially by the neutralization of § 170.3(o)(12) of this chapter. lactic acid with potassium hydroxide. (d) The ingredient is used in food at (b) The ingredient must be of a pu- levels not to exceed good manufac- rity suitable for its intended use. turing practice in accordance with (c) In accordance with § 184.1(b)(1), § 184.1(b)(1). Current good manufac- the ingredient is used in food with no turing practice results in a maximum limitation other than current good level, as served, of 0.015 percent for manufacturing practice. This regula- nonalcoholic beverages as defined in tion does not authorize its use in in- § 170.3(n)(3) of this chapter. 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- facturing practice conditions of use: [45 FR 6086, Jan. 25, 1980, as amended at 49 (1) The ingredient is used as a flavor FR 5613, Feb. 14, 1984] enhancer as defined in § 170.3(o)(11) of this chapter; a flavoring agent or adju- § 184.1655 Propane. vant as defined in § 170.3(o)(12) of this (a) Propane (empirical formula C3H8, chapter; a humectant as defined in CAS Reg. No. 74–98–6) is also known as § 170.3(o)(16) of this chapter; and a pH dimethylmethane or propyl hydrid. It control agent as defined in § 170.3(o)(23) is a colorless, odorless, flammable gas of this chapter. at normal temperatures and pressures. (2) The ingredient is used in food at It is easily liquefied under pressure at levels not to exceed current good man- room temperature and is stored and ufacturing practice. shipped in the liquid state. Propane is

561

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00571 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1660 21 CFR Ch. I (4–1–15 Edition)

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 sorption to surface-active agents, or re- the fat or oil content, including the es- frigeration. sential (volatile) oil content, of the (b) The ingredient must be of a pu- food. rity suitable for its intended use. (e) 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, or different from that limitations other than current good stated in part 181 of this chapter, do manufacturing practice. The affirma- not exist or have been waived. tion of this ingredient as generally rec- ognized as safe (GRAS) as a direct [42 FR 14653, Mar. 15, 1977, as amended at 44 human food ingredient is based upon FR 52826, Sept. 11, 1979; 49 FR 5613, Feb. 14, the following current good manufac- 1984] turing practice conditions of use: (1) The ingredient is used as a propel- § 184.1666 Propylene glycol. lant, aerating agent, and gas as defined (a) Propylene glycol (C3H8O2, CAS in § 170.3(o)(25) of this chapter. Reg. No. 57–55–6) is known as 1,2- (2) The ingredient is used in food at propanediol. It does not occur in na- levels not to exceed current good man- ture. Propylene glycol is manufactured ufacturing practice. by treating propylene with chlorinated (d) Prior sanctions for this ingredient water to form the chlorohydrin which different from the uses established in is converted to the glycol by treatment this section do not exist or have been with sodium carbonate solution. It is waived. also prepared by heating glyercol with [48 FR 57271, Dec. 29, 1983, as amended at 73 sodium hydroxide. FR 8608, Feb. 14, 2008] (b) The ingredient meets the speci- fications of the Food Chemicals Codex, § 184.1660 Propyl gallate. 3d Ed. (1981), p. 255, which is incor- (a) Propyl gallate is the n- porated by reference. Copies may be propylester of 3,4,5-trihydroxybenzoic obtained from the National Academy acid (C10H12O5). Natural occurrence of Press, 2101 Constitution Ave. NW., propyl gallate has not been reported. It Washington, DC 20418. It is also avail- is commercially prepared by able for inspection at the National Ar- esterification of gallic acid with propyl chives and Records Administration alcohol followed by distillation to re- (NARA). For information on the avail- move excess alcohol. ability of this material at NARA, call (b) The ingredient meets the speci- 202–741–6030, or go to: http:// fications of the ‘‘Food Chemicals www.archives.gov/federallregister/ Codex,’’ 3d Ed. (1981), pp. 257–258, which codeloflfederallregulations/ is incorporated by reference. Copies ibrllocations.html. may be obtained from the National (c) The ingredient is used as an Academy Press, 2101 Constitution Ave. anticaking agent as defined in NW., Washington, DC 20418, or may be § 170.3(o)(1) of this chapter; antioxidant examined at the National Archives and as defined in § 170.3(o)(3) of this chap- Records Administration (NARA). For ter; dough strengthener as defined in information on the availability of this § 170.3(o)(6) of this chapter; emulsifier material at NARA, call 202–741–6030, or as defined in § 170.3(o)(8) of this chap- go to: http://www.archives.gov/ ter; flavor agent as defined in federallregister/ § 170.3(o)(12) of this chapter; formula- codeloflfederallregulations/ tion aid as defined in § 170.3(o)(14) of ibrllocations.html. this chapter; humectant as defined in (c) The ingredient is used as an anti- § 170.3(o)(16) of this chapter; processing oxidant as defined in § 170.3(o)(3) of this aid as defined in § 170.3(o)(24) 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 practice in accordance with § 170.3(o)(28) of this chapter; surface-ac- § 184.1(b)(1). Good manufacturing prac- tive agent as defined in § 170.3(o)(29) of

562

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00572 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1676

this chapter; and texturizer as defined this regulation do not exist or have in § 170.3(o)(32) of this chapter. been waived. (d) The ingredient is used in foods at [42 FR 14653, Mar. 15, 1977, as amended at 49 levels not to exceed current good man- FR 5613, Feb. 14, 1984] ufacturing practice in accordance with § 184.1(b)(1). Current good manufac- § 184.1676 Pyridoxine hydrochloride. turing practice results in maximum (a) Pyridoxine hydrochloride levels, as served, of 5 percent for alco- (C8H11NO3·HCl, CAS Reg. No. 58–56–0) is holic beverages, as defined in the chemical 3-hydroxy–4,5- § 170.3(n)(2) of this chapter; 24 percent dihydroxymethy–2-methylpyridine hy- for confections and frostings as defined drochloride that is prepared by chem- in § 170.3(n)(9) of this chapter; 2.5 per- ical synthesis. cent for frozen dairy products as de- (b) The ingredient meets the speci- fined in § 170.3(n)(20) of this chapter; 97 fications of the Food Chemicals Codex, percent for seasonings and flavorings 3d Ed. (1981), p. 260, which is incor- as defined in § 170.3(n)(26) of this chap- porated by reference. Copies are avail- ter; 5 percent for nuts and nut products able from the National Academy Press, as defined in § 170.3(n)(32) of this chap- 2101 Constitution Ave. NW., Wash- ter; and 2.0 percent for all other food ington, DC 20418, or available for in- categories. spection at the National Archives and (e) 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/ [47 FR 27812, June 25, 1982] codeloflfederallregulations/ § 184.1670 Propylparaben. ibrllocations.html. (c) In accordance with § 184.1(b)(1), (a) Propylparaben is the chemical the ingredient is used in food with no propyl p-hydroxybenzoate. It is pro- limitation other than current good duced by the n-propanol esterification manufacturing practice. The affirma- of p-hydroxybenzoic acid in the pres- tion of this ingredient as generally rec- ence of sulfuric acid, with subsequent ognized as safe (GRAS) as a direct distillation. human food ingredient is based upon (b) The ingredient meets the speci- the following current good manufac- fications of the ‘‘Food Chemicals turing practice conditions of use: Codex,’’ 3d Ed. (1981), p. 258, which is in- (1) The ingredient is used as a nutri- corporated by reference. Copies may be ent supplement as defined in obtained from the National Academy § 170.3(o)(20) 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 as defined in § 170.3(n)(1) of information on the availability of this this chapter; nonalcoholic beverages material at NARA, call 202–741–6030, or and beverage bases as defined in go to: http://www.archives.gov/ § 170.3(n)(3) of this chapter; breakfast federallregister/ cereals as defined in § 170.3(n)(4) of this codeloflfederallregulations/ chapter; dairy product analogs as de- ibrllocations.html. fined in § 170.3(n)(10) of this chapter; (c) The ingredient is used as an anti- meat products as defined in microbial agent as defined in § 170.3(n)(29) of this chapter; milk prod- § 170.3(o)(2) of this chapter. ucts as defined in § 170.3(n)(31) of this (d) The ingredient is used in food at chapter; plant protein products as de- levels not to exceed good manufac- fined in § 170.3(n)(33) of this chapter; turing practices. Current good manu- and snack foods as defined in facturing practice results in a max- § 170.3(n)(37) of this chapter. Pyridoxine imum level of 0.1 percent in food. hydrochloride may be used in infant (e) Prior sanctions for this ingredient formula in accordance with section different from the uses established in 412(g) of the Federal Food, Drug, and

563

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00573 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1685 21 CFR Ch. I (4–1–15 Edition)

Cosmetic Act (the Act) or with regula- (4) Chymosin preparation is a clear tions promulgated under section solution containing the active enzyme 412(a)(2) of the Act. 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- [48 FR 51615, Nov. 10, 1983] onym A. awamori Nakazawa) con- taining the prochymosin gene. § 184.1685 Rennet (animal-derived) Chymosin is recovered from the fer- and chymosin preparation (fer- mentation broth after acid treatment. mentation-derived). All materials used in the processing (a)(1) Rennet and bovine rennet are and formulating of chymosin prepara- commercial extracts containing the ac- tion must be either generally recog- tive enzyme rennin (CAS Reg. No. 9001– nized as safe (GRAS) or be food addi- 98–3), also known as chymosin (Inter- tives that have been approved by the national Union of Biochemistry En- Food and Drug Administration for this zyme Commission (E.C.) 3.4.23.4). use. Rennet is the aqueous extract prepared from cleaned, frozen, salted, or dried (b) Rennet and chymosin preparation fourth stomachs (abomasa) of calves, meet the general and additional re- kids, or lambs. Bovine rennet is the quirements for enzyme preparations of product from adults of the animals list- the ‘‘Food Chemicals Codex,’’ 3d Ed. ed above. Both products are called (1981), pp. 107–110, which is incorporated rennet and are clear amber to dark by reference in accordance with 5 brown liquid preparations or white to U.S.C. 552(a). Copies are available from tan powders. the National Academy Press, 2101 Con- (2) Chymosin preparation is a clear stitution Avenue NW., Washington, DC solution containing the active enzyme 20418, or are available for inspection at chymosin (E.C. 3.4.23.4). It is derived, the National Archives and Records Ad- via fermentation, from a nonpatho- ministration (NARA). For information genic and nontoxigenic strain of Esch- on the availability of this material at erichia coli K–12 containing the NARA, call 202–741–6030, or go to: http:// prochymosin gene. The prochymosin is www.archives.gov/federallregister/ isolated as an insoluble aggregate that codeloflfederallregulations/ is acid-treated to destroy residual cel- ibrllocations.html. lular material and, after solubilization, (c) In accordance with § 184.1(b)(1), is acid-treated to form chymosin. It the ingredient is used in food with no must be processed with materials that limitation other than current good are generally recognized as safe, or are manufacturing practice. The affirma- food additives that have been approved tion of this ingredient as generally rec- by the Food and Drug Administration ognized as safe as a direct human food for this use. ingredient is based upon the following (3) Chymosin preparation is a clear current good manufacturing practice solution containing the active enzyme conditions of use: chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a nonpatho- (1) The ingredient is used as an en- genic and nontoxigenic strain of zyme as defined in § 170.3(o)(9) of this Kluyveromyces marxianus variety lactis, chapter; a processing aid as defined in containing the prochymosin gene. The § 170.3(o)(24) of this chapter; and a sta- prochymosin is secreted by cells into bilizer and thickener as defined in fermentation broth and converted to § 170.3(o)(28) of this chapter. chymosin by acid treatment. All mate- (2) The ingredient is used in the fol- rials used in the processing and formu- lowing foods at levels not to exceed lating of chymosin must be either gen- current good manufacturing practice: erally recognized as safe (GRAS), or be In cheeses as defined in § 170.3(n)(5) of food additives that have been approved this chapter; frozen dairy desserts and by the Food and Drug Administration mixes as defined in § 170.3(n)(20) of this for this use. chapter; gelatins, puddings, and fillings

564

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00574 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1697

as defined in § 170.3(n)(22) of this chap- this section do not exist or have been ter; and milk products as defined in waived. § 170.3(n)(31) of this chapter. [48 FR 51148, Nov. 7, 1983] (d) Prior sanctions for this ingredient different from the uses established in § 184.1697 Riboflavin–5′-phosphate (so- this section do not exist or have been dium). waived. (a) Riboflavin-5′-phosphate (sodium) [55 FR 10935, Mar. 23, 1990, as amended at 57 (C17H20N4O9PNa·2H2O, CAS Reg. No 130– FR 6479, Feb. 25, 1992; 58 FR 27202, May 7, 40–5) occurs as the dihydrate in yellow 1993] to orange-yellow crystals. It is pre- pared by phosphorylation of riboflavin § 184.1695 Riboflavin. with chlorophosphoric acid, (a) Riboflavin (C17H20N4O6, CAS Reg. pyrophosphoric acid, metaphosphoric No. 83–88–5) occurs as yellow to orange- acid, or pyrocatechol cyclic phosphate. yellow needles that are crystallized (b) The ingredient meets the speci- from 2N acetic acid, alcohol, water, or fications of the Food Chemicals Codex, pyridine. It may be prepared by chem- 3d Ed. (1981), p. 263, which is incor- ical synthesis, biosynthetically by the porated by reference. Copies are avail- organism Eremothecium ashbyii, or iso- able from the National Academy Press, lated from natural sources. 2101 Constitution Ave. NW., Wash- (b) The ingredient meets the speci- ington DC 20418, or available for inspec- fications of the Food Chemicals Codex, tion at the National Archives and 3d Ed. (1981), p. 262, 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 a nutri- tion of this ingredient as generally rec- ent supplement as defined in ognized as safe (GRAS) as a direct § 170.3(o)(20) of this chapter. human food ingredient is based upon (2) The ingredient is used in milk the following current good manufac- products, as defined in § 170.3(n)(31) of turing practice conditions of use: this chapter, at levels not to exceed (1) The ingredient is used as a nutri- current good manufacturing practice. ent supplement as defined in The ingredient may also be used in in- § 170.3(o)(20) of this chapter. fant formulas in accordance with sec- (2) The ingredient is used in foods at tion 412(g) of the Federal Food, Drug, levels not to exceed current good man- and Cosmetic Act (the Act) or with reg- ufacturing practice. The ingredient ulations promulgated under section may also be used in infant formula in 412(a)(2) of the Act. accordance with section 412(g) of the (d) Prior sanctions for this ingredient Federal Food, Drug, and Cosmetic Act different from the uses established in (the Act) or with regulations promul- this section do not exist or have been gated under section 412(a)(2) of the Act. waived. (d) Prior sanctions for this ingredient different from the uses established in [48 FR 51148, Nov. 7, 1983]

565

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00575 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1698 21 CFR Ch. I (4–1–15 Edition)

§ 184.1698 Rue. Ruta—Ruta montana L., Ruta graveolens (a) Rue is the perennial herb of sev- L., Ruta bracteosa L., and Ruta L. eral species of Ruta (Ruta montana L., calepensis (b) Oil of rue meets the specifications Ruta graveolens L., Ruta bracteosa L., of the ‘‘Food Chemicals Codex,’’ 4th ed. and Ruta calepensis L.). The leaves, buds, and stems from the top of the (1996), pp. 342–343, which is incorporated plant are gathered, dried, and then by reference in accordance with 5 crushed in preparation for use, or left U.S.C. 552(a) and 1 CFR part 51. Copies whole. are available from the National Acad- (b) The ingredient is used in all cat- emy Press, Box 285, 2101 Constitution egories of food in accordance with Ave. NW., Washington, DC 20055 (Inter- § 184.1(b)(2) of this chapter at con- net address http://www.nap.edu), or may centrations not to exceed 2 parts per be examined at the Center for Food million. Safety and Applied Nutrition’s Li- (c) Prior sanctions for this ingredient brary, Food and Drug Administration, different from the uses established in 5100 Paint Branch Pkwy., College Park, this section do not exist or have been MD 20740, or at the National Archives waived. and Records Administration (NARA). For information on the availability of [43 FR 3705, Jan. 27, 1978] this material at NARA, call 202–741– 6030, or go to: http://www.archives.gov/ § 184.1699 Oil of rue. federallregister/ (a) Oil of rue is the natural substance codeloflfederallregulations/ obtained by steam distillation of the ibrllocations.html. fresh blossoming plants of rue, the pe- (c) The ingredient is used in food rennial herb of several species of under the following conditions:

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 (1) Saponification value of 185 to 195, different from the uses established in (2) Iodine value of 28 to 43, this section do not exist or have been (3) Unsaponifiable matter not to ex- waived. ceed 1.5 percent, [42 FR 14653, Mar. 15, 1977, as amended at 49 (4) Free fatty acids not more than 0.1 FR 5613, Feb. 14, 1984; 64 FR 1760, Jan. 12, percent as oleic acid, 1999] (5) Peroxide value not more than 10 milliequivalents/equivalent (meq/eq), § 184.1702 Sheanut oil. (6) Lead not more than 0.1 part per (a) Sheanut oil is produced from million (ppm), sheanuts derived from the Shea tree (7) Copper not more than 0.1 ppm. Butyrospermum parkii and is composed (c) In accordance with § 184.1(b)(3), principally of triglycerides containing the ingredient is used in the following an oleic acid moiety at the 2-position food categories at levels not to exceed and saturated fatty acids, usually ste- current good manufacturing practice, aric or palmitic acids, at the 1- and 3- except that the ingredient may not be positions. used in a standardized food unless per- (b) The ingredient meets the fol- mitted by the standard of identity: lowing specifications when tested using Confections and frostings as defined in any appropriate validated method- § 170.3(n)(9) of this chapter, coatings of ology: soft candy as defined in § 170.3(n)(38) of

566

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00576 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1724

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 § 170.3(n)(25) of this chapter; 0.12 per- § 184.1721 Sodium acetate. cent for jams and jellies as defined in § 170.3(n)(28) of this chapter and meat (a) Sodium acetate (C H O Na, CAS 2 3 2 products as defined in § 170.3(n)(29) of Reg. No. 127–09–3 or C H O Na·3H O, 2 3 2 2 this chapter; 0.2 percent for soft candy CAS Reg. No. 6131–90–4) is the sodium salt of acetic acid and occurs naturally as defined in § 170.3(n)(38) of this chap- in plant and animal tissues. Sodium ac- ter; 0.05 percent for soups and soup etate may occur in either the anhy- mixes as defined in § 170.3(n)(40) of this drous or trihydrated form. It is pro- chapter and sweet sauces as defined in duced synthetically by the neutraliza- § 170.3(n)(43) of this chapter. tion of acetic acid with sodium car- (e) Prior sanctions for this ingredient bonate or by treating calcium acetate different from the uses established in with sodium sulfate and sodium bicar- this section do not exist or have been bonate. waived. (b) The ingredient meets the speci- [47 FR 27815, June 25, 1982] fications of the Food Chemicals Codex, 3d Ed. (1981), pp. 272, 273 which is incor- § 184.1724 Sodium alginate. porated by reference. Copies are avail- able from the National Academy Press, (a) Sodium alginate (CAS Reg. No. 2101 Constitution Ave. NW., Wash- 9005–38–3) is the sodium salt of alginic ington, DC 20418, or available for in- acid, a natural polyuronide constituent spection at the National Archives and of certain brown algae. Sodium algi- Records Administration (NARA). For nate is prepared by the neutralization information on the availability of this of purified alginic acid with appro- material at NARA, call 202–741–6030, or priate pH control agents. go to: http://www.archives.gov/ (b) The ingredient meets the speci- federallregister/ fications of the Food Chemicals Codex, codeloflfederallregulations/ 3d Ed. (1981), p. 274, which is incor- ibrllocations.html. porated by reference. Copies are avail- (c) The ingredient is used as a fla- able from the National Academy Press, voring agent and adjuvant as defined in 2101 Constitution Ave. NW., Wash- § 170.3(o)(12) of this chapter; and as a pH ington, DC 20418, or available for in- control agent as defined in § 170.3(o)(23) spection at the National Archives and of this chapter. Records Administration (NARA). For (d) The ingredient is used in food at information on the availability of this levels not to exceed current good man- material at NARA, call 202–741–6030, or ufacturing practice in accordance with go to: http://www.archives.gov/ 184.1(b)(1). Current good manufacturing federallregister/ practice results in a maximum level, as codeloflfederallregulations/ served, of 0.007 percent for breakfast ibrllocations.html. cereals as defined in § 170.3(n)(4) of this (c) In accordance with § 184.1(b)(2), chapter; 0.5 percent for fats and oils as the ingredient is used in food only defined in § 170.3(n)(12) of this chapter; within the following specific limita- 0.6 percent for grain products and pas- 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.

567

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00577 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1733 21 CFR Ch. I (4–1–15 Edition)

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

Gelatins and puddings, § 170.3(n)(22) of this chapter ..... 4.0 Firming agent, § 170.3(o)(10) of this chapter; flavor adju- vant, § 170.3(o)(12) of this chapter; stabilizer, thick- ener, § 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- (e) Prior sanctions for this ingredient nate different from the uses established different from the uses established in in this section do not exist or have this section, or different from that set been waived. forth in part 181 of this chapter, do not [47 FR 29951, July 9, 1982, as amended at 48 exist or have been waived. FR 52448, Nov. 18, 1983] [42 FR 14653, Mar. 15, 1977, as amended at 49 § 184.1733 Sodium benzoate. FR 5613, Feb. 14, 1984] (a) Sodium benzoate is the chemical § 184.1736 Sodium bicarbonate. benzoate of soda (C7H5NaO2), produced by the neutralization of benzoic acid (a) Sodium bicarbonate (NaHCO3, with sodium bicarbonate, sodium car- CAS Reg. No. 144–55–8) is prepared by bonate, or sodium hydroxide. The salt treating a sodium carbonate or a so- is not found to occur naturally. dium carbonate and sodium bicarbon- (b) The ingredient meets the speci- ate solution with carbon dioxide. As fications of the ‘‘Food Chemicals carbon dioxide is absorbed, a suspen- Codex,’’ 3d Ed. (1981), p. 278, which is in- sion of sodium bicarbonate forms. The corporated by reference. Copies may be slurry is filtered, forming a cake which obtained from the National Academy is washed and dried. Press, 2101 Constitution Ave. NW., (b) The ingredient meets the speci- Washington, DC 20418, or may be exam- fications of the Food Chemicals Codex, ined at the National Archives and 3d Ed. (1981), p. 278, 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. (c) The ingredient is used as an anti- information on the availability of this microbial agent as defined in material at NARA, call 202–741–6030, or § 170.3(o)(2) of this chapter, and as a fla- go to: http://www.archives.gov/ voring agent and adjuvant as defined in federallregister/ § 170.3(o)(12) of this chapter. codeloflfederallregulations/ (d) The ingredient is used in food at ibrllocations.html. levels not to exceed good manufac- (c) In accordance with § 184.1(b)(1), turing practice. Current usage results the ingredient is used in food with no in a maximum level of 0.1 percent in limitation other than current good food. (The Food and Drug Administra- manufacturing practice. tion has not determined whether (d) Prior sanctions for this ingredient significally different conditions of use different from the uses established in would be GRAS.)

568

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00578 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1754

this section do not exist or have been § 184.1751 Sodium citrate. waived. (a) Sodium citrate (C6H5Na3O7·2H2O, [48 FR 52442, Nov. 18, 1983] CAS Reg. No. 68–0904–092) is the sodium salt of citric acid. It is prepared by § 184.1742 Sodium carbonate. neutralizing citric acid with sodium hydroxide or sodium carbonate. The (a) Sodium carbonate (Na2CO3, CAS Reg. No. 497–19–8) is produced (1) from product occurs as colorless crystals or purified trona ore that has been a white crystalline powder. It may be calcined to soda ash; (2) from trona ore prepared in an anhydrous state or may calcined to impure soda ash and then contain two moles of water per mole of purified; or (3) synthesized from lime- sodium citrate. stone by the Solvay process. (b) The ingredient meets the speci- (b) The ingredient meets the speci- fications of the Food Chemicals Codex, fications of the Food Chemicals Codex, 3d ed. (1981), pp. 283–284, which is incor- 3d Ed. (1981), p. 280, which is incor- porated 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 Ave. NW., Wash- Academy Press, 2101 Constitution Ave. ington, DC 20418, or available for in- NW., Washington, DC 20418, and the spection at the National Archives and Center for Food Safety and Applied Nu- Records Administration (NARA). For trition (HFS–200), 5100 Paint Branch information on the availability of this Pkwy., College Park, MD 20740, or may material at NARA, call 202–741–6030, or be examined at the National Archives go to: http://www.archives.gov/ and Records Administration (NARA). federallregister/ For information on the availability of codeloflfederallregulations/ this material at NARA, call 202–741– 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 (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. human food ingredient is based upon (d) Prior sanctions for this ingredient the following current good manufac- different from the uses established in turing practice conditions of use: this section, or different from those set (1) The ingredient is used in food as forth in part 181 of this chapter, do not an antioxidant as defined in § 170.3(o)(3) exist or have been waived. of this chapter; curing and pickling agent as defined in § 170.3(o)(5) of this [59 FR 63896, Dec. 12, 1994] chapter; flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chap- § 184.1754 Sodium diacetate. ter; pH control agent as defined in (a) Sodium diacetate (C4H7O4Na·xH2O, § 170.3(o)(23) of this chapter; and proc- CAS Reg. No. 126–96–5) is a molecular essing aid as defined in § 170.3(o)(24) of compound of acetic acid, sodium ace- this chapter. tate, and water of hydration. The tech- (2) The ingredient is used in food at nical grade is prepared synthetically levels not to exceed current good man- by reacting sodium carbonate with ace- ufacturing practice. tic acid. Special grades are produced by (d) Prior sanctions for this ingredient reacting anhydrous sodium acetate and different from the uses established in acetic acid. this section do not exist or have been (b) The ingredient meets the speci- waived. fications of the Food Chemicals Codex, 3d Ed. (1981), p. 284, which is incor- [48 FR 52442, Nov. 18, 1983, as amended at 50 porated by reference. Copies are avail- FR 49536, Dec. 3, 1985] able from the National Academy Press,

569

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00579 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1763 21 CFR Ch. I (4–1–15 Edition)

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 codeloflfederallregulations/ limitation other than current good ibrllocations.html. manufacturing practice. The affirma- (c) The ingredient is used as an anti- tion of this ingredient as generally rec- microbial agent as defined in ognized as safe (GRAS) as a direct § 170.3(o)(2) of this chapter; flavoring human food ingredient is based upon agent and adjuvant as defined in the following current good manufac- § 170.3(o)(12) of this chapter; and pH turing practice conditions of use: control agent as defined in § 170.3(o)(23) (1) The ingredient is used as a pH of this chapter. control agent as defined in § 170.3(o)(23) (d) The ingredient is used in food at of this chapter and as a processing aid levels not to exceed current good man- as defined in § 170.3(o)(24) of this chap- ufacturing practice in accordance with ter. § 184.1(b)(1). Current good manufac- (2) The ingredient is used in foods at turing practice results in a maximum levels not to exceed current good man- level, as served, 0.4 percent for baked ufacturing practice. goods as defined in § 170.3(n)(1) of this (d) Prior sanctions for this ingredient chapter; 0.1 percent for fats and oils as different from the uses established in defined in § 170.3(n)(12) of this chapter, this section do not exist or have been meat products as defined in waived. § 170.3(n)(29) of this chapter and soft candy as defined in § 170.3(n)(38) of this [48 FR 52444, Nov. 18, 1983] chapter; 0.25 percent for gravies and sauces as defined in § 170.3(n)(24) of this § 184.1764 Sodium hypophosphite. chapter; and 0.05 percent for snack (a) Sodium hypophosphite (NaH2PO2, foods as defined in § 170.3(n)(37) of this CAS Reg. No. 7681–53–0) is a white, chapter and soups and soup mixes as odorless, deliquescent granular powder defined in § 170.3(n)(40) of this chapter. with a saline taste. It is also prepared (e) Prior sanctions for this ingredient as colorless, pearly crystalline plates. different from the uses established in It is soluble in water, alcohol, and this section do not exist or have been glycerol. It is prepared by neutraliza- waived. tion of hypophosphorous acid or by di- [47 FR 27815, June 25, 1982] rect aqueous alkaline hydrolysis of white phosphorus. § 184.1763 Sodium hydroxide. (b) The ingredient must be of a pu- (a) Sodium hydroxide (NaOH, CAS rity suitable for its intended use. Reg. No. 1310–73–2) is also known as so- (c) In accordance with § 184.1(b)(1), dium hydrate, soda lye, caustic soda, the ingredient is used in food with no white caustic, and lye. The empirical limitations other than current good formula is NaOH. Sodium hydroxide is manufacturing practice. The affirma- prepared commercially by the elec- tion of this ingredient as generally rec- trolysis of sodium chloride solution ognized as safe (GRAS) as a direct and also by reacting calcium hydroxide human food ingredient is based upon with sodium carbonate. the following current good manufac- (b) The ingredient meets the speci- turing practice conditions of use: fications of the Food Chemicals Codex, (1) The ingredient is used as an emul- 3d Ed. (1981), which is incorporated by sifier or stabilizer, as defined in reference. Copies are available from §§ 170.3(o)(8) and 170.3(o)(28) of this the National Academy Press, 2101 Con- chapter. stitution Ave. NW., Washington, DC (2) The ingredient is used in cod-liver 20418, or available for inspection at the oil emulsions at levels not to exceed National Archives and Records Admin- current good manufacturing practice.

570

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00580 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1784

(d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1), different from the use 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- tion of this ingredient as generally rec- [47 FR 38277, Aug. 31, 1982, as amended at 73 FR 8608, Feb. 14, 2008] ognized as safe (GRAS) as a direct human food ingredient is based upon § 184.1768 Sodium lactate. the following current good manufac- turing practice conditions of use: (a) Sodium lactate (C3H5O3Na, CAS (1) The ingredient is used as a proc- Reg. No. 72–17–3) is the sodium salt of essing aid as defined in § 170.3(o)(24) of lactic acid. It is prepared commercially this chapter. by the neutralization of lactic acid (2) The ingredient is used to treat the with sodium hydroxide. following foods at levels not to exceed (b) The ingredient must be of a pu- current good manufacturing practice: rity suitable for its intended use. for use in washing and lye peeling of (c) In accordance with § 184.1(b)(1), fruits, vegetables, and nuts when used the ingredient is used in food with no in accordance with § 173.315 of this limitation other than current good chapter; for use as a denuding agent in manufacturing practice. This regula- tripe; for use as a hog scald agent in re- tion does not authorize its use in in- moving hair; and for use as a corrosion fant foods and infant formulas. The af- preventative in canned and bottled firmation of this ingredient as gen- water when used in accordance with erally recognized as safe (GRAS) as a § 165.110 of this chapter. direct human food ingredient is based (d) Prior sanctions for this ingredient upon the following current good manu- different from the uses established in facturing practice conditions of use: this section do not exist or have been (1) The ingredient is used as an emul- waived. sifier as defined in § 170.3(o)(8) of this chapter; a flavor enhancer as defined in [50 FR 38781, Sept. 25, 1985; 50 FR 42011, Oct. § 170.3(o)(11) of this chapter; a flavoring 17, 1985, as amended at 72 FR 10357, Mar. 8, 2007; 73 FR 8608, Feb. 14, 2008] agent or adjuvant as defined in § 170.3(o)(12) of this chapter; a humec- § 184.1784 Sodium propionate. tant as defined in § 170.3(o)(16) of this (a) Sodium propionate (C H NaO , chapter; and a pH control agent as de- 3 5 2 CAS Reg. No. 137–40–6) is the sodium fined in § 170.3(o)(23) of this chapter. salt of propionic acid. It occurs as (2) The ingredient is used in food at colorless, transparent crystals or a levels not to exceed current good man- granular crystalline powder. It is odor- ufacturing practice. less, or has a faint acetic-butyric acid (d) Prior sanctions for this ingredient odor, and is deliquescent. It is prepared different from the uses established in by neutralizing propionic acid with so- this section do not exist or have been dium hydroxide. waived. (b) The ingredients meets the speci- [52 FR 10886, Apr. 6, 1987, as amended at 73 fications of the Food Chemicals Codex, FR 8608, Feb. 14, 2008] 3d Ed. (1981), p. 296, which is incor- porated by reference. Copies are avail- § 184.1769a Sodium metasilicate. able from the National Academy Press, (a) Sodium metasilicate (CAS Reg. 2101 Constitution Ave. NW., Wash- No. 6834–92–0) is a strongly alkaline ington DC 20418, or available for inspec- white powder. It does not occur natu- tion at the National Archives and rally but rather is synthesized by melt- Records Administration (NARA). For ing sand with sodium carbonate at 1400 information on the availability of this °C. The commercially available forms material at NARA, call 202–741–6030, or of sodium metasilicate are the anhy- go to: http://www.archives.gov/ drous form (Na2SiO3), the pentahydrate federallregister/ (Na2SiO3·5H2O), and the nonahydrate codeloflfederallregulations/ (Na2SiO3·9H2O). ibrllocations.html. (b) The ingredient must be of a pu- (c) In accordance with § 184.1(b)(1), rity suitable for its intended use. the ingredient is used in food with no

571

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00581 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1792 21 CFR Ch. I (4–1–15 Edition)

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 as an anti- the following current good manufac- microbial agent as defined in turing practice conditions of use: § 170.3(o)(2) of this chapter and a fla- (1) The ingredient is used as a pH voring agent as defined in § 170.3(o)(12) control agent as defined in § 170.3(o)(23) of this chapter. of this chapter. (2) The ingredient is used in the fol- (2) The ingredient is used in cream at lowing foods at levels not to exceed levels not to exceed current good man- current good manufacturing practice: ufacturing practice. Current good man- baked goods as defined in § 170.3(n)(1) of ufacturing practice utilizes a level of this chapter; nonalcoholic beverages as the ingredient sufficient to control lac- defined in § 170.3(n)(3) of this chapter; tic acid prior to pasteurization and cheeses as defined in § 170.3(n)(5) of this churning of cream into butter. chapter; confections and frostings as (d) Prior sanctions for this ingredient defined in § 170.3(n)(9) of this chapter; different from the uses established in gelatins, puddings, and fillings as de- this section do not exist or have been fined in § 170.3(n)(22) of this chapter; waived. jams and jellies as defined in § 170.3(n)(28) of this chapter; meat prod- [48 FR 52443, Nov. 18, 1983] ucts as defined in § 170.3(n)(29) of this § 184.1801 Sodium tartrate. chapter; and soft candy as defined in § 170.3(n)(38) of this chapter. (a) Sodium tartrate (C4H4Na2O6·2H2O, (d) Prior sanctions for this ingredient CAS Reg. No. 868–18–8) is the disodium ¥ ¥ different from the uses established in salt of L (+) tartaric acid. It occurs this section do not exist or have been as transparent, colorless, and odorless waived. crystals. It is obtained as a byproduct of wine manufacture. [49 FR 13142, Apr. 3, 1984] (b) The ingredient meets the speci- fications of the Food Chemicals Codex, § 184.1792 Sodium sesquicarbonate. 3d Ed. (1981), p. 303, which is incor- (a) Sodium sesquicarbonate porated by reference. Copies are avail- (Na2CO3·NaHCO3·2H2O, CAS Reg. No. able from the National Academy Press, 533–96–0) is prepared by: (1) Partial 2101 Constitution Ave. NW., Wash- carbonation of soda ash solution fol- ington, DC 20418, or available for in- lowed by crystallization, centrifuga- spection at the National Archives and tion, and drying; (2) double refining of Records Administration (NARA). For trona ore, a naturally occurring im- information on the availability of this pure sodium sesquicarbonate. 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. 299, 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 an emul- ibrllocations.html. sifier as defined in § 170.3(o)(8) of this

572

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00582 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1807

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] and jellies as defined in § 170.3(n)(28) of this chapter. § 184.1807 Sodium thiosulfate. (d) Prior sanctions for this ingredient (a) Sodium thiosulfate (Na2S2O3·5H2O, different from the uses established in CAS Reg. No. 010102–0917–097) is also this section do not exist or have been known as sodium hyposulfite. It is pre- waived. pared synthetically by the reaction of [48 FR 52447, Nov. 18, 1983] sulfides and sulfur dioxide (SO2), the reaction of sulfur and sulfite, or the ox- § 184.1804 Sodium potassium tartrate. idation of metal sulfides and (a) Sodium potassium tartrate hydrosulfides. (b) The ingredient meets the speci- (C4H4KNaO6·4H2O, CAS Reg. No. 304–59– 6) is the sodium potassium salt of fications of the ‘‘Food Chemicals L¥(+)¥tartaric acid and is also called Codex,’’ 3d Ed. (1981), p. 304, which is in- the Rochelle salt. It occurs as colorless corporated by reference. Copies may be crystals or as a white, crystalline pow- obtained from the National Academy der and has a cooling saline taste. It is Press, 2101 Constitution Ave. NW., obtained as a byproduct of wine manu- Washington, DC 20418, or may be exam- facture. ined 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. 296, 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 formu- Records Administration (NARA). For lation aid as defined in § 170.3(o)(14) of information on the availability of this this chapter and reducing agent as de- material at NARA, call 202–741–6030, or fined in § 170.3(o)(22) of this chapter. go to: http://www.archives.gov/ (d) The ingredient is used in alco- federallregister/ codeloflfederallregulations/ holic beverages and table salt in ac- ibrllocations.html. cordance with § 184.1(b)(1) at levels not (c) In accordance with § 184.1(b)(1), to exceed good manufacturing practice. the ingredient is used in food with no Current good manufacturing practice limitation other than current good results in a maximum level, as served, manufacturing practice. The affirma- of 0.00005 percent for alcoholic bev- tion of this ingredient as generally rec- erages as defined in § 170.3(n)(2) of this ognized as safe (GRAS) as a direct chapter and 0.1 percent for table salt as human food ingredient is based upon defined in § 170.3(n)(26) of this chapter. the following current good manufac- (e) Prior sanctions for this ingredient turing practice conditions of use: different from the uses established in (1) The ingredient is used as an emul- this section do not exist or have been sifier as defined in § 170.3(o)(8) of this waived. chapter and as a pH control agent as defined in § 170.3(o)(23) of this chapter. [43 FR 22938, May 30, 1978, as amended at 49 FR 5613, Feb. 4, 1984] (2) The ingredient is used in the fol- lowing foods at levels not to exceed current good manufacturing practice: cheeses as defined in § 170.3(n)(5) of this

573

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00583 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1835 21 CFR Ch. I (4–1–15 Edition)

§ 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- standardized jams and jellies, commer- hexanehexol (C6H14O6), a hexahydric al- cohol, differing from 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 corporated by reference. Copies may be 50 grams of sorbitol shall bear the obtained from the National Academy statement: ‘‘Excess consumption may Press, 2101 Constitution Ave. NW., have a effect.’’ Washington, DC 20418, or may be exam- (f) Prior sanctions for this ingredient ined at the National Archives and different from the uses established in Records Administration (NARA). For this regulation do not exist or have information on the availability of this been waived. material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ [42 FR 14653, Mar. 15, 1977, as amended at 49 federallregister/ FR 5613, Feb. 14, 1984] codeloflfederallregulations/ ibrllocations.html. § 184.1845 Stannous chloride (anhy- (c) The ingredient is used as an drous and dihydrated). anticaking agent and free-flow agent as (a) Stannous chloride is anhydrous or defined in § 170.3(o)(1) of this chapter, contains two molecules of water of hy- curing and pickling agent as defined in dration. Anhydrous stannous chloride § 170.3(o)(5) of this chapter, drying (SnCl2, CAS Reg. No. 7772–99–8) is the agent as defined in § 170.3(o)(7) of this chloride salt of metallic tin. It is pre- chapter, emulsifier and emulsifier salt pared by reacting molten tin with ei- as defined in § 170.3(o)(8) of this chap- ther chlorine or gaseous tin tetra- ter, firming agent as defined in chloride. Dihydrated stannous chloride § 170.3(o)(10) of this chapter, flavoring (SnCl2·2H2O, CAS Reg. No. 10025–69–1) is agent and adjuvant as defined in the chloride salt of metallic tin that § 170.3(o)(12) of this chapter, formula- contains two molecules of water. It is tion aid as defined in § 170.3(o)(14) of prepared from granulated tin sus- this chapter, humectant as defined in pended in water and hydrochloric acid § 170.3(o)(16) of this chapter, lubricant or chlorine. and release agent as defined in (b) Both forms of the ingredient meet § 170.3(o)(18) of this chapter, nutritive sweetener as defined in § 170.3(o)(21) of the specifications of the Food Chemi- this chapter, sequestrant as defined in cals Codex, 3d Ed. (1981), p. 312, which is § 170.3(o)(26) of this chapter, stabilizer incorporated by reference. Copies are and thickener as defined in § 170.3(o)(28) available from the National Academy of this chapter, surface-finishing agent Press, 2101 Constitution Ave. NW., as defined in § 170.3(o)(30) of this chap- Washington, DC 20418, or available for ter, and texturizer as defined in inspection at the National Archives § 170.3(o)(32) of this chapter. and Records Administration (NARA). (d) The ingredient is used in food at For information on the availability of levels not to exceed good manufac- this material at NARA, call 202–741– turing practices. Current good manu- 6030, or go to: http://www.archives.gov/ facturing practice in the use of sorbitol federallregister/ results in a maximum level of 99 per- codeloflfederallregulations/ cent in hard candy and cough drops as ibrllocations.html. defined in § 170.3(n)(25) of this chapter, (c) The ingredient is used as an anti- 75 percent in chewing gum as defined in oxidant as defined in § 170.3(o)(3) of this § 170.3(n)(6) of this chapter, 98 percent chapter.

574

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00584 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1854

(d) The ingredient is used in food at § 184.1851 Stearyl citrate. 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 this section do not exist or have been limitation other than current good waived. manufacturing practice. The affirma- [47 FR 27816, June 25, 1982, as amended at 76 tion of this ingredient as generally rec- FR 59250, Sept. 26, 2011] ognized as safe (GRAS) as a direct human food ingredient is based upon § 184.1848 Starter distillate. the following current good manufac- (a) Starter distillate (butter starter turing practice conditions of use: distillate) is a steam distillate of the (1) The ingredient is used as an anti- culture of any or all of the following oxidant as defined in § 170.3(o)(3) of this species of bacteria grown on a medium chapter; an emulsifier and emulsifier consisting of skim milk usually for- salt as defined in § 170.3(o)(8) of this tified with about 0.1 percent citric acid: chapter; a sequestrant as defined in Streptococcus lactis, S. cremoris, S. lactis § 170.3(o)(26) of this chapter; and a sur- subsp. diacetylactis, Leuconostoc face-active agent as defined in citrovorum, and L. dextranicum. The in- § 170.3(o)(29) of this chapter. gredient contains more than 98 percent (2) The ingredient is used in mar- water, and the remainder is a mixture garine in accordance with § 166.110 of of butterlike flavor compounds. Diace- this chapter; in nonalcoholic beverages tyl is the major flavor component, con- as defined in § 170.3(n)(3) of this chap- stituting as much as 80 to 90 percent of ter; and in fats and oils as defined in the mixture of organic flavor com- § 170.3(n)(12) of this chapter at levels pounds. Besides diacetyl, starter dis- not to exceed current good manufac- tillate contains minor amounts of acet- turing practice. aldehyde, ethyl formate, ethyl acetate, (d) Prior sanctions for this ingredient acetone, ethyl alcohol, 2-butanone, different from the uses established in acetic acid, and acetoin. 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), [59 FR 63897, Dec. 12, 1994, as amended at 73 the ingredient is used in food with no FR 8608, Feb. 14, 2008] limitation other than current good manufacturing practice. The affirma- § 184.1854 Sucrose. tion of this ingredient as generally rec- (a) Sucrose (C12H22O11, CAS Reg. No. ognized as safe (GRAS) as a direct 57–50–11–1) sugar, cane sugar, or beet human food ingredient is based upon sugar is the chemical b-D- the following current good manufac- fructofuranosyl-a-D-glucopyranoside. turing practice conditions of use: Sucrose is obtained by crystallization (1) The ingredient is used as a fla- from sugar cane or sugar beet juice voring agent and adjuvant as defined in that has been extracted by pressing or § 170.3(o)(12) of this chapter. diffusion, then clarified and evapo- (2) The ingredient is used in food at rated. levels not to exceed current good man- (b) The ingredient must be of a pu- ufacturing practice. 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 with no this section do not exist or have been limitation other than current good waived. manufacturing practice. [48 FR 51907, Nov. 15, 1983, as amended at 73 (d) Prior sanctions for this ingredient FR 8608, Feb. 14, 2008] different from the uses established in

575

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00585 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1857 21 CFR Ch. I (4–1–15 Edition)

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 [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, manufacturing practice. 1989, as amended at 73 FR 8608, Feb. 14, 2008] (d) Prior sanctions for this ingredient § 184.1857 Corn sugar. different from the uses established in this section do not exist or have been (a) Corn sugar (C6H12O6, CAS Reg. No. waived. 50–99–7), commonly called D-glucose or dextrose, is the chemical a-D- [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, glucopyranose. It occurs as the anhy- 1989, as amended at 73 FR 8608, Feb. 14, 2008] drous or the monohydrate form and is § 184.1865 Corn syrup. produced by the complete hydrolysis of corn starch with safe and suitable acids (a) Corn syrup, commonly called or enzymes, followed by refinement and ‘‘glucose sirup’’ or ‘‘glucose syrup,’’ is crystallization from the resulting hy- obtained by partial hydrolysis of corn drolysate. starch with safe and suitable acids or (b) The ingredient meets the speci- enzymes. It may also occur in the de- fications of the Food Chemicals Codex, hydrated form (dried glucose sirup). 3d Ed. (1981), pp. 97–98 under the head- Depending on the degree of hydrolysis, ing ‘‘Dextrose,’’ which is incorporated corn syrup may contain, in addition to by reference in accordance with 5 glucose, maltose and higher U.S.C. 552(a) and 1 CFR part 1. Copies saccharides. are available from the National Acad- (b) The ingredient meets the speci- emy Press, 2101 Constitution Ave., NW., fications as defined and determined in Washington, DC 20418, or available for § 168.120(b) or § 168.121(a) of this chapter, inspection at the National Archives as appropriate. and Records Administration (NARA). (c) In accordance with § 184.1(b)(1), For information on the availability of the ingredient is used in food with no this material at NARA, call 202–741– limitation other than current good 6030, or 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 waived. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no [53 FR 44876, Nov. 7, 1988, as amended at 73 limitation other than current good FR 8608, Feb. 14, 2008] manufacturing practice. (d) Prior sanctions for this ingredient § 184.1866 High fructose corn syrup. different from the uses established in (a) High fructose corn syrup, a sweet, this section do not exist or have been nutritive saccharide mixture con- waived. taining either approximately 42 or 55 percent fructose, is prepared as a clear [53 FR 44876, Nov. 7, 1988] aqueous solution from high dextrose- equivalent corn starch hydrolysate by § 184.1859 Invert sugar. partial enzymatic conversion of glu- (a) Invert sugar (CAS Reg. No. 8013– cose (dextrose) to fructose using an in- 17–0) is an aqueous solution of inverted soluble glucose isomerase enzyme prep- or partly inverted, refined or partly re- aration described in § 184.1372. The fined sucrose, the solids of which con- product containing more than 50 per- tain not more than 0.3 percent by cent fructose (dry weight) is prepared weight of ash. The solution is colorless, through concentration of the fructose odorless, and flavorless, except for portion of the mixture containing less sweetness. It is produced by the hydrol- than 50 percent fructose. ysis or partial hydrolysis of sucrose (b) The ingredient shall conform to with safe and suitable acids or en- the identity and specifications listed in zymes. the monograph entitled ‘‘High-Fruc- (b) The ingredient must be of a pu- tose Corn Syrup’’ in the Food Chemi- rity suitable for its intended use. cals Codex, 4th ed. (1996), pp. 191–192,

576

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00586 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1878

which is incorporated by reference in the following current good manufac- accordance with 5 U.S.C. 552(a) and 1 turing practice conditions of use: CFR part 51. Copies are available from (1) The ingredient is used as a fla- the Office of Food Additive Safety voring agent and adjuvant as defined in (HFS–200), Center for Food Safety and § 170.3(o)(12) of this chapter or as a nu- Applied Nutrition, Food and Drug Ad- trient supplement as defined in ministration, 5100 Paint Branch Pkwy., § 170.3(o)(20) of this chapter. College Park, MD 20740, 240–402–1200, or (2) The ingredient is used in food at may be examined at the Center for levels not to exceed current good man- Food Safety and Applied Nutrition’s ufacturing practice. Thiamine hydro- Library, 5100 Paint Branch Pkwy., Col- chloride may be used in infant formula lege Park, MD 20740, or at the National in accordance with section 412(g) of the Archives and Records Administration Federal Food, Drug, and Cosmetic Act (NARA). For information on the avail- (the Act) or with regulations promul- ability of this material at NARA, call gated under section 412(a)(2) of the Act. 202–741–6030, or go to: http:// (d) Prior sanctions for this ingredient www.archives.gov/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), [48 FR 55124, Dec. 9, 1983] the ingredient is used in food with no limitation other than current good § 184.1878 Thiamine mononitrate. manufacturing practice. (a) Thiamine mononitrate [61 FR 43450, Aug. 23, 1996, as amended at 78 (C12H17N5O4S, CAS Reg. No. 532–43–4) is FR 14667, Mar. 7, 2013] the mononitrate salt of thiamine. It occurs as white crystals or a white § 184.1875 Thiamine hydrochloride. crystalline powder and is prepared from thiamine hydrochloride by dis- (a) Thiamine hydrochloride solving the hydrochloride salt in alka- (C12H17C1N4OS·HCl, CAS Reg. No. 67–03– line solution followed by precipitation 8) is the chloride-hydrochloride salt of of the nitrate half-salt with a stoichio- thiamine. It occurs as hygroscopic metric amount of nitric acid. white crystals or a white crystalline (b) The ingredient meets the speci- powder. The usual method of preparing fications of the Food Chemicals Codex, this substance is by linking the 3d Ed. (1981), p. 325, which is incor- preformed thiazole and pyrimidine ring porated by reference. Copies are avail- systems. able from the National Academy Press, (b) The ingredient meets the speci- 2101 Constitution Ave. NW., Wash- fications of the Food Chemicals Codex, ington, DC 20418, or available for in- 3d Ed. (1981), p. 324, which is incor- spection at the National Archives and porated by reference. Copies are avail- Records Administration (NARA). For able from the National Academy Press, information on the availability of this 2101 Constitution Ave. NW., Wash- material at NARA, call 202–741–6030, or ington, DC 20418, or available for in- 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 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.

577

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00587 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1890 21 CFR Ch. I (4–1–15 Edition)

(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 [49 FR 13348, Apr. 4, 1984] in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act § 184.1901 Triacetin. (the Act) or with regulations promul- 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 pre- pared by heating glycerin with acetic [48 FR 55124, Dec. 9, 1983] anhydride alone or in the presence of finely divided potassium hydrogen sul- α § 184.1890 -Tocopherols. fate. It can also be prepared by the re- (a) The a-tocopherols that are the action of oxygen with a liquid-phase subject of this GRAS affirmation regu- mixture of allyl acetate and acetic acid lation are limited to the following: using a bromide salt as a catalyst. (1) d-a-Tocopherol (CAS Reg. No. 59– (b) The ingredient meets the speci- 02–9) is the chemical [2R,4′R,8prime;R]- fications of the Food Chemicals Codex, 2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyl- 3d Ed. (1981), pp. 337–338, as revised by tridecyl)-6-chromanol. It occurs com- the First Supplement to the 3d Ed., mercially as a concentrate and is a red, which is incorporated by reference in nearly odorless, viscous oil. It is ob- accordance with 5 U.S.C. 552(a). Copies tained by vacuum steam distillation of are available from the National Acad- edible vegetable oil products. emy Press, 2102 Constitution Ave., NW., (2) dl-a-Tocopherol (CAS Reg. No. Washington, DC 20418, or available for 10191–41–0) is a mixture of inspection at the National Archives stereoisomers of 2,5,7,8-tetramethyl-2- and Records Administration (NARA). (4′,8′,12′-trimethyl-tridecyl)-6- For information on the availability of chromanol. It is chemically syn- this material at NARA, call 202–741– thesized by condensing racemic 6030, or go to: http://www.archives.gov/ isophytol with trimethyl hydro- federallregister/ quinone. It is a pale yellow viscous oil codeloflfederallregulations/ at room temperature. ibrllocations.html. (b) The ingredients meet 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), pp. 330–331, 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 in food as a material at NARA, call 202–741–6030, or flavoring agent and adjuvant as defined go to: http://www.archives.gov/ in § 170.3(o)(12) of this chapter; a formu- federallregister/ lation aid as defined in § 170.3(o)(14) of codeloflfederallregulations/ this chapter; and humectant as defined ibrllocations.html. in § 170.3(o)(16) of this chapter; and a (c) In accordance with § 184.1(b)(3), solvent and vehicle as defined in the affirmation of the ingredients as § 170.3(o)(27) of this chapter. generally recognized as safe is limited (2) The ingredient is used in the fol- to the following conditions of use while lowing foods at levels not to exceed the agency concludes the general eval- current good manufacturing practice: uation of all food uses of tocopherols: baked goods and baking mixes as de- (1) The ingredients are used as inhibi- fined in § 170.3(n)(1) of this chapter, al- tors of nitrosamine formation. coholic beverages as defined in

578

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00588 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1911

§ 170.3(n)(2) of this chapter; non- this chapter; alcoholic beverages as de- alcoholic beverages and beverage bases fined in § 170.3(n)(2) of this chapter; as defined in § 170.3(n)(3) of this chap- nonalcoholic beverages as defined in ter; chewing gum as defined in § 170.3(n)(3) of this chapter; fats and oils § 170.3(n)(6) of this chapter; confections as defined in § 170.3(n)(12) of this chap- and frostings as defined in § 170.3(n)(9) ter; frozen dairy desserts and mixes as of this chapter; frozen dairy dessert defined in § 170.3(n)(20) of this chapter; and mixes as defined in § 170.3(n)(20) of gelatins, puddings and fillngs as de- this chapter; gelatins, puddings, and fined in § 170.3(n)(22) of this chapter; fillngs as defined in § 170.3(n)(22) of this and soft candy as defined in chapter; hard candy as defined in § 170.3(n)(38) of this chapter. § 170.3(n)(25) of this chapter; and soft (d) Prior sanctions for this ingredient candy as defined in § 170.3(n)(38) of this different from the uses established in chapter. this section do not exist or have been (d) Prior sanctions for this ingredient waived. different from the uses established in [54 FR 7404, Feb. 21, 1989; 54 FR 10482, Mar. 13, this section do not exist or have been 1989] waived. [54 FR 7404, Feb. 21, 1989] § 184.1911 Triethyl citrate. (a) Triethyl citrate (C12H20O7, CAS § 184.1903 Tributyrin. Reg. No. 77–93–0) is the triethyl ester of

(a) Tributyrin (C15H26O6, CAS Reg. citric acid. It is prepared by esterifying No. 60–01–5), also known as butyrin or citric acid with ethyl alcohol and oc- glyceryl tributyrate, is the triester of curs as an odorless, practically color- glycerin and butyric acid. It is pre- less, oily liquid. pared by esterification of glycerin with (b) The ingredient meets the speci- excess butyric acid. fications of the Food Chemicals Codex, (b) The ingredient meets the speci- 3d ed. (1981), p. 339, which is incor- fication of the Food Chemicals Codex, porated by reference in accordance 3d Ed. (1981), p. 416, which is incor- with 5 U.S.C. 552(a) and 1 CFR part 51. porated by reference in accordance Copies are available from the National with 5 U.S.C. 552(a). Copies are avail- Academy Press, 2101 Constitution Ave. able from the National Academy Press, NW., Washington, DC 20418, and the 2101 Constitution Ave. NW., Wash- Center for Food Safety and Applied Nu- ington, DC 20418, or available for in- trition (HFS–200), 5100 Paint Branch spection at the National Archives and Pkwy., College Park, MD 20740, or may Records Administration (NARA). For be examined at the National Archives information on the availability of this and Records Administration (NARA). material at NARA, call 202–741–6030, or For information on the availability of go to: http://www.archives.gov/ this material at NARA, call 202–741– federallregister/ 6030, or 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)(1), limitation other than current good the ingredient is used in food with no manufacturing practice. The affirma- limitation other than current good tion of this ingredient as generaly rec- manufacturing practice. The affirma- ognized as safe (GRAS) as a direct tion of this ingredient as generally rec- human food ingredient is based upon ognized as safe (GRAS) as a direct the following current good manufac- human food ingredient is based upon turing practice conditions of use: the following current good manufac- (1) The ingredient is used in food as a turing practice conditions of use: flavoring agent and adjuvant as defined (1) The ingredient is used as a fla- in § 170.3(o)(12) of this chapter. voring agent as defined in § 170.3(o)(12) (2) The ingredient is used in the fol- of this chapter; a solvent and vehicle as lowing foods at levels not to exceed defined in § 170.3(o)(27) of this chapter; current good manufacturing practice; and a surface-active agent as defined in baked goods as defined in § 170.3(n)(1) of § 170.3(o)(29) of this chapter.

579

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00589 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1914 21 CFR Ch. I (4–1–15 Edition)

(2) The ingredient is used in foods at § 184.1923 Urea. levels not to exceed current good man- (a) Urea (CO(NH ) , CAS Reg. No. 57– ufacturing practice. 2 2 13–6) is the diamide of carbonic acid (d) Prior sanctions for this ingredient and is also known as carbamide. It is a different from the uses established in white, odorless solid and is commonly this section, or different from those set produced from CO2 by ammonolysis or forth in part 181 of this chapter, do not from cyanamide by hydrolysis. exist or have been waived. (b) The ingredient must be of a pu- [59 FR 63897, Dec. 12, 1994] rity suitable for its intended use. (c) In accordance with § 184.1(b)(1), § 184.1914 Trypsin. the ingredient is used in food with no (a) Trypsin (CAS Reg. No. 9002–07–7) limitation other than current good manufacturing practice. The affirma- is an enzyme preparation obtained tion of this ingredient as generally rec- from purified extracts of porcine or bo- ognized as safe as a direct human food vine pancreas. It is a white to tan ingredient is based upon the following amorphous powder. Its characterizing current good manufacturing practice enzyme activity is that of a peptide hy- conditions of use: drolase (EC 3.4.21.4). (1) The ingredient is used as a formu- (b) The ingredient meets the general lation aid as defined in § 170.3(o)(14) of requirements and additional require- this chapter and as a fermentation aid. ments for enzyme preparations in the (2) The ingredient is used in yeast- Food Chemicals Codex, 3d ed. (1981), p. raised bakery products; in alcoholic 110, which is incorporated by reference beverages as defined in § 170.3(n)(2) of in accordance with 5 U.S.C. 552(a) and 1 this chapter; and in gelatin products. CFR part 51. Copies are available from (d) Prior sanctions for this ingredient the National Academy Press, 2101 Con- different from the uses established in stitution Ave. NW., Washington, DC this section do not exist or have been 20418, or may be examined at the Office waived. of Food Additive Safety (HFS–200), Center for Food Safety and Applied Nu- [48 FR 51616, Nov. 10, 1983, as amended at 49 trition, Food and Drug Administration, FR 19816, May 10, 1984; 73 FR 8608, Feb. 14, 5100 Paint Branch Pkwy., College Park, 2008] MD 20740, 240–402–1200, and at the Na- § 184.1924 Urease enzyme preparation tional Archives and Records Adminis- from Lactobacillus fermentum. tration (NARA). For information on the availability of this material at (a) This enzyme preparation is de- NARA, call 202–741–6030, or go to: http:// rived from the nonpathogenic, www.archives.gov/federallregister/ nontoxicogenic bacterium Lactobacillus codeloflfederallregulations/ fermentum. It contains the enzyme ibrllocations.html. urease (CAS Reg. No. 9002–13–5), which (c) In accordance with § 184.1(b)(1), facilitates the hydrolysis of urea to the ingredient is used in food with no ammonia and carbon dioxide. It is pro- limitation other than current good duced by a pure culture fermentation manufacturing practice. The affirma- process and by using materials that are tion of this ingredient as GRAS as a di- generally recognized as safe (GRAS) or rect food ingredient is based upon the are food additives that have been ap- following current good manufacturing proved for this use by the Food and practice conditions of use: Drug Administration (FDA). (b) The ingredient meets the general (1) The ingredient is used as an en- and additional requirements for en- zyme as defined in § 170.3(o)(9) of this zyme preparations in the ‘‘Food Chemi- chapter to hydrolyze proteins or cals Codex,’’ 3d ed. (1981), pp. 107–110, polypeptides. which is incorporated by reference in (2) The ingredient is used in food at accordance with 5 U.S.C. 552(a) and 1 levels not to exceed current good man- CFR part 51. Copies are available from ufacturing practice. the National Academy Press, 2101 Con- [60 FR 32911, June 26, 1995, as amended at 78 stitution Ave. NW., Washington, DC FR 14667, Mar. 7, 2013] 20418, or available for inspection at the

580

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00590 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1945

National Archives and Records Admin- www.archives.gov/federallregister/ istration (NARA). For information on codeloflfederallregulations/ the availability of this material at ibrllocations.html. NARA, call 202–741–6030, or go to: http:// (c) In accordance with § 184.1(b)(1), www.archives.gov/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 (GRAS) as a direct limitation other than current good human food ingredient is based upon manufacturing practice. The affirma- the following current good manufac- tion of this ingredient as GRAS as a di- turing practice conditions of use: rect human food ingredient is based (1) The ingredient is used in food as a upon the following current good manu- nutrient supplement as defined in facturing practice conditions of use: § 170.3(o)(20) of this chapter. (1) The ingredient is used in wine, as (2) The ingredient is used in foods at defined in 27 CFR 2.5 and 4.10, as an en- levels not to exceed current good man- zyme as defined in § 170.3(o)(9) of this ufacturing practice. Vitamin A may be chapter to convert urea to ammonia used in infant formula in accordance and carbon dioxide. with section 412(g) of the Federal Food, (2) The ingredient is used in food at Drug, and Cosmetic Act (the act) or levels not to exceed current good man- with regulations promulgated under ufacturing practice. Current good man- section 412(a)(2) of the Act. ufacturing practice is limited to use of (d) Prior sanctions for this ingredient this ingredient in wine to inhibit for- different from the uses established in mation of ethyl carbamate. this section do not exist or have been waived. [57 FR 60473, Dec. 21, 1992] [48 FR 51610, Nov. 10, 1983] § 184.1930 Vitamin A. (a)(1) Vitamin A (retinol; CAS Reg. § 184.1945 Vitamin B 12. No. 68–26–8) is the alcohol 9,13-di- (a) Vitamin B12, also known as cyano- methyl-7-(1,1,5-trimethyl-6-cyclohexen- cobalamin (C63H88CoN14O14P, CAS Reg. 5-yl)-7,9,11,13-nonatetraen-15-ol. It may No. 68–0919–099), is produced commer- be nearly odorless or have a mild fishy cially from cultures of Streptomyces odor. Vitamin A is extracted from fish griseus. liver oils or produced by total syn- (b) The ingredient meets the speci- thesis from b-ionone and a propargyl fications of the Food Chemicals Codex, halide. 3d Ed. (1981), p. 343, which is incor- (2) Vitamin A acetate (retinyl ace- porated by reference. Copies are avail- tate; CAS Reg. No. 127–47–9) is the ace- able from the National Academy Press, tate ester of retinol. It is prepared by 2101 Constitution Ave. NW., Wash- esterifying retinol with acetic acid. ington, DC 20418, or available for in- (3) Vitamin A palmitate (retinyl spection at the National Archives and palmitate; CAS Reg. No. 79–81–2) is the Records Administration (NARA). For palmitate ester of retinol. It is pre- information on the availability of this pared by esterifying retinol with pal- material at NARA, call 202–741–6030, or mitic acid. go to: http://www.archives.gov/ (b) The ingredient meets the speci- federallregister/ fications for vitamin A in the Food codeloflfederallregulations/ Chemicals Codex, 3d Ed. (1981), p. 342, ibrllocations.html. which is incorporated by reference. (c) In accordance with § 184.1(b)(1), Copies are available from the National the ingredient is used in food with no Academy Press, 2101 Constitution Ave. limitation other than current good NW., Washington, DC 20418, or avail- manufacturing practice. The affirma- able for inspection at the National Ar- tion of this ingredient as generally rec- chives and Records Administration ognized as safe (GRAS) as a direct (NARA). For information on the avail- human food ingredient is based upon ability of this material at NARA, call the following current good manufac- 202–741–6030, or go to: http:// turing practice conditions of use:

581

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00591 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1950 21 CFR Ch. I (4–1–15 Edition)

(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 (d) Prior sanctions for this ingredient sole source of added vitamin D only different from the uses established in within the following specific limita- this section do not exist or have been tions: waived. Category of food Maximum levels in Functional use [50 FR 6341, Feb. 15, 1985] food (as served) Breakfast cereals, 350 (IU/100 Nutrient supple- § 184.1950 Vitamin D. § 170.3(n)(4) of grams). ment, (a) Vitamin D is added to food as the this chapter. § 170.3(o)(20) of this chapter. following food ingredients: Grain products and 90(IU/100 grams) Do. (1) Crystalline vitamin D2 (C28H44O, pastas, CAS Reg. No. 50–14–6), also known as § 170.3(n)(23) of ergocalciferol, is the chemical 9,10- this chapter. Milk, § 170.3(n)(30) 42 (IU/100 grams) Do. seco(5Z,7E,22E)-5,7,10(19),22- of this chapter. ergostatetraen-3-ol. The ingredient is Milk products, 89 (IU/100 grams) Do. produced by ultraviolet irradiation of § 170.3(n)(31) of ergosterol isolated from yeast and re- this chapter. lated fungi and is purified by crys- (2) Vitamin D may be used in infant tallization. formula in accordance with section (2) Crystalline vitamin D (C H O, 3 27 44 412(g) of the Federal Food, Drug, and CAS Reg. No. 67–97–0), also known as Cosmetic Act (the act) or with regula- cholecalciferol, is the chemical 9,10- tions promulgated under section seco(5Z,7E,)-5,7,10(19)-cholestatrien-3- 412(a)(2) of the act. ol. Vitamin D occurs in, and is iso- 3 (3) Vitamin D may be used in mar- lated from, fish liver oils. It is also garine in accordance with § 166.110 of manufactured by ultraviolet irradia- this chapter. tion of 7-dehydrocholesterol produced (d) Prior sanctions for these ingredi- from cholesterol. It is purified by crys- ents different from the uses established tallization. Vitamin D is the vitamin 3 in this section do not exist or have D form that is produced endogenously been waived. in humans through sunlight activation of 7-dehydrocholesterol in the skin. [50 FR 30152, July 24, 1985, as amended at 73 (3) Vitamin D2 resin and vitamin D3 FR 8608, Feb. 14, 2008] resin are the concentrated forms of ir- § 184.1973 Beeswax (yellow and white). radiated ergosterol (D2) and irradiated 7-dehydrocholesterol (D3) that are sepa- (a) Beeswax (CAS Reg. No. 8012–89–3) rated from the reacting materials in is a secretory product of honey bees paragraphs (a) (1) and (2) of this sec- used as a structural material in honey- tion. The resulting products are sold as combs. Beeswax is prepared from hon- food sources of vitamin D without fur- eycombs after removal of the honey by ther purification. draining or centrifuging. The combs (b) Vitamin D2 and vitamin D3 as are melted in hot water or steam or crystals meet the specifications of the with solar heat, and strained. The wax Food Chemicals Codex, 3d Ed. (1981), is refined by melting in hot water to pp. 344 and 345, which is incorporated which sulfuric acid or alkali may be by reference. Copies are available from added to extract impurities. The re- the National Academy Press, 2101 Con- sulting wax is referred to as yellow stitution Ave. NW., Washington, DC beeswax. White beeswax is produced by 20418, or available for inspection at the bleaching the constituent pigments of

582

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00592 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1978

yellow beeswax with peroxides, or pref- porated by reference. Copies are avail- erably it is bleached by sun light. able from the National Academy Press, (b) The ingredient meets the speci- 2101 Constitution Ave. NW., Wash- fications of the ‘‘Food Chemicals ington, DC 20418, or available for in- Codex,’’ 3d Ed. (1981), pp. 34–35, which is spection at the National Archives and incorporated by reference. Copies may Records Administration (NARA). For be obtained from the National Acad- information on the availability of this emy Press, 2101 Constitution Ave. NW., material at NARA, call 202–741–6030, or Washington, DC 20418, or may be exam- go to: http://www.archives.gov/ ined 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/ ibrllocations.html. manufacturing practice. The affirma- (c) 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, as a lubri- human food ingredient is based upon cant as defined in § 170.3(o)(18) of this the following current good manufac- chapter, and as a surface-finishing turing practice conditions of use: agent as defined in § 170.3(o)(30) of this (1) The ingredient is used as a lubri- chapter. cant as defined in § 170.3(o)(18) of this (d) The ingredient is used in food, in chapter and as a surface-finishing accordance with § 184.1(b)(1) of this agent as defined in § 170.3(o)(30) of this chapter, at levels not to exceed good chapter. manufacturing practice. Current good (2) The ingredient is used in the fol- manufacturing practice results in a lowing foods at levels not to exceed maximum level, as served, of: 0.065 per- current good manufacturing practice: cent for chewing gum as defined in in chewing gum as defined in § 170.3(n)(6) of this chapter; 0.005 per- § 170.3(n)(6) of this chapter and in hard cent for confections and frostings as candy as defined in § 170.3(n)(25) of this defined in § 170.3(n)(9) of this chapter; chapter. 0.04 percent for hard candy as defined (d) Prior sanctions for this ingredient in § 170.3(n)(25) of this chapter; 0.1 per- different from the uses established in cent for soft candy as defined in this section do not exist or have been § 170.3(n)(38) of this chapter; and 0.002 waived. percent or less for all other food cat- egories. [48 FR 51617, Nov. 10, 1983] [43 FR 14644, Apr. 7, 1978, as amended at 49 § 184.1978 Carnauba wax. FR 5613, Feb. 14, 1984; 50 FR 49536, Dec. 3, 1985] (a) Carnauba wax (CAS Reg. No. 008– 015–869) is obtained from the leaves and § 184.1976 Candelilla wax. buds of the Brazilian wax palm (a) Candelilla wax (CAS Reg. No. Copernicia cerifera Martius. The wax is 8006–44–8) is obtained from the can- hard, brittle, sparingly soluble in cold delilla plant. It is a hard, yellowish- organic solvents and insoluble in brown, opaque-to-translucent wax. water. It is marketed in five grades Candelilla wax is prepared by immers- designated No. 1 through No. 5. Grades ing the plants in boiling water con- No. 4 and No. 5 represent the bulk of taining sulfuric acid and skimming off the commercial trade volume. These the wax that rises to the surface. It is commercial grades consist chiefly of composed of about 50 percent hydro- C24 to C32 normal saturated carbons with smaller amounts of esters monofunctional fatty acids and normal and free acids. saturated monofunctional primary al- (b) The ingredient meets the speci- cohols. fications of the Food Chemicals Codex, (b) The ingredient meets the speci- 3d Ed. (1981), p. 67, which is incor- fications of the Food Chemicals Codex,

583

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00593 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1979 21 CFR Ch. I (4–1–15 Edition)

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 codeloflfederallregulations/ grams. The acidity of whey, sweet or ibrllocations.html. acid, may be adjusted by the addition (c) In accordance with § 184.1(b)(1), of safe and suitable pH-adjusting ingre- the ingredient is used in food with no dients. limitation other than current good (2) Concentrated whey. Concentrated manufacturing practice. The affirma- whey is the liquid substance obtained tion of this ingredient as generally rec- by the partial removal of water from ognized as safe (GRAS) as a direct whey, while leaving all other constitu- human food ingredient is based upon ents in the same relative proportions the following current good manufac- as in whey. turing practice conditions of use: (3) Dry or dried whey. Dry or dried (1) The ingredient is used as an whey is the dry substance obtained by anticaking agent as defined § 170.3(o)(1) the removal of water from whey, while of this chapter; as a formulation aid as leaving all other constituents in the defined in § 170.3(o)(14) of this chapter; same relative proportions as in whey. as a lubricant and release agent as de- (b) The ingredients meet the fol- fined in § 170.3(o)(18) of this chapter; lowing specifications: and as a surface-finishing agent as de- (1) The analysis of whey, con- fined in § 170.3(o)(30) of this chapter. centrated whey, and dry (dried) whey, (2) The ingredient is used in the fol- on a dry product basis, based on ana- lowing foods at levels not to exceed lytical methods in the referenced sec- current good manufacturing practice: tions of ‘‘Official Methods of Analysis baked goods and baking mixes as de- of the Association of Official Analyt- fined in § 170.3(n)(1) of this chapter; ical Chemists,’’ 13th ed. (1980), which is chewing gun as defined in § 170.3(n)(6) of incorporated by reference in accord- this chapter; confections and frostings ance with 5 U.S.C. 552(a) and 1 CFR as defined in § 170.3(n)(9) of this chap- part 51, is given in paragraphs (b)(1)(i) ter; fresh fruits and fruit juices as de- through (b)(1)(vii) of this section. Cop- fined in § 170.3(n)(16) of this chapter; ies may be obtained from the AOAC gravies and sauces as defined in INTERNATIONAL, 481 North Frederick § 170.3(n)(24) of this chapter; processed Ave., suite 500, Gaithersburg, MD 20877, fruits and fruit juices as defined in or may be examined at the Center for § 170.3(n)(35) of this chapter; and soft Food Safety and Applied Nutrition’s candy as defined in § 170.3(n)(38) of this Library, Food and Drug Administra- chapter. tion, 5100 Paint Branch Pkwy., College (d) Prior sanctions for this ingredient Park, MD 20740, or at the National Ar- different from the uses established in chives and Records Administration this section do not exist or have been (NARA). For information on the avail- waived. ability of this material at NARA, call [48 FR 51147, Nov. 7, 1983] 202–741–6030, or go to: http:// www.archives.gov/federallregister/ § 184.1979 Whey. codeloflfederallregulations/ (a)(1) Whey. Whey is the liquid sub- ibrllocations.html. stance obtained by separating the co- (i) Protein content, 10 to 15 percent— agulum from milk, cream, or skim as determined by the methods pre- milk in cheesemaking. Whey obtained scribed in section 16.036 (liquid sample), from a procedure, in which a signifi- entitled ‘‘Total Nitrogen—Official cant amount of lactose is converted to Final Action’’ under the heading

584

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00594 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1979a

‘‘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/ 16.199 (dry sample), entitled ‘‘Fat in federallregister/ Dried Milk (45)—Official Final Action.’’ codeloflfederallregulations/ (iii) Ash content, 7 to 14 percent—as ibrllocations.html. determined by the methods prescribed (3) The whey must be derived from in section 16.035 (liquid sample), enti- milk that has been pasteurized, or the tled ‘‘Ash (5)—Official Final Action’’ whey and modified whey product must under the heading ‘‘Total Solids,’’ or in be subjected to pasteurization tech- section 16.196 (dry sample), entitled niques or its equivalent before use in ‘‘Ash—Official Final Action’’ under the food. heading ‘‘Dried Milk, Nonfat Dry Milk, (c) Whey, concentrated whey, and dry and Malted Milk.’’ (dried) whey may be used in food in ac- (iv) Lactose content, 61 to 75 per- cordance with good manufacturing cent—as determined by the methods practice as indicated in § 184.1(b)(1). prescribed in section 16.057 (liquid sam- (d) The label on the whey form sold ple), entitled ‘‘Gravimetric Method— to food manufacturers shall read as fol- Official Final Action’’ under the head- lows: ing ‘‘Lactose,’’ or in section 31.061 (dry (1) For whey: ‘‘(Sweet or acid) whey’’ sample), entitled ‘‘Lane-Eynon General or ‘‘whey (ll% titratable acidity). Volumetric Method’’ under the heading (2) For concentrated whey: ‘‘Con- ‘‘Lactose—Chemical Methods—Official centrated (sweet or acid) whey, ll% Final Action.’’ solids’’ or ‘‘Concentrated whey (ll% (v) Moisture content, 1 to 8 percent— titratable acidity), ll% solids’’. as determined by the methods pre- (3) For dry (dried) whey: ‘‘Dry (dried) scribed in section 16.192, entitled (sweet or acid) whey’’ or ‘‘dry (dried) ‘‘Moisture (41)—Official Final Action’’ whey, (ll% titratable acidity)’’. under the heading ‘‘Dried Milk, Nonfat (e) Whey, concentrated whey, or dry Dry Milk, and Malted Milk.’’ (dried) whey in a finished food product (vi) Solids content, variable—as de- shall be listed as ‘‘whey.’’ termined by the methods prescribed in section 16.032, entitled ‘‘Method I—Offi- [46 FR 44439, Sept. 4, 1981; 47 FR 7410, Feb. 19, cial Final Action’’ under the heading 1982, as amended at 54 FR 24899, June 12, 1989; ‘‘Total Solids.’’ 64 FR 1760, Jan. 12, 1999] (vii) Titratable Acidity, variable—as determined by the methods prescribed § 184.1979a Reduced lactose whey. in section 16.023, entitled ‘‘Acidity (2)— (a) Reduced lactose whey is the sub- Official Final Action’’ under the head- stance obtained by the removal of lac- ing ‘‘Milk,’’ or by an equivalent poten- tose from whey. The lactose content of tiometric method. the finished dry product shall not ex- (2) Limits of impurities are: Heavy ceed 60 percent. Removal of the lactose metals (as lead). Not more than 10 is accomplished by physical separation parts per million (0.001 percent) as de- techniques such as precipitation, filtra- termined by the method described in tion, or dialysis. As with whey, reduced the ‘‘Food Chemicals Codex,’’ 4th ed. lactose whey can be used as a fluid, (1996), pp. 760–761, which is incorporated concentrate, or a dry product form. by reference in accordance with 5 The acidity of reduced lactose whey U.S.C. 552(a) and 1 CFR part 51. Copies may be adjusted by the addition of safe are available from the National Acad- and suitable pH-adjusting ingredients. emy Press, Box 285, 2101 Constitution (b) The reduced lactose whey meets Ave. NW., Washington, DC 20055 (Inter- the following specifications:

585

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00595 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1979a 21 CFR Ch. I (4–1–15 Edition)

(1) The analysis of reduced lactose heading ‘‘Lactose—Chemical Meth- whey, on a dry product basis, based on ods—Official Final Action.’’ analytical methods in the referenced (v) Moisture content, 1 to 6 percent— sections of ‘‘Official Methods of Anal- as determined by the method pre- ysis of the Association of Official Ana- scribed in section 16.192, entitled lytical Chemists,’’ 13th ed. (1980), which ‘‘Moisture (41)—Official Final Action’’ is 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, 16 to 24 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, 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, 11 to 27 percent—as ibrllocations.html. determined by the methods prescribed (3) The reduced lactose whey shall be in section 16.035 (liquid sample), enti- derived from milk that has been pas- tled ‘‘Ash (5)—Official Final Action’’ teurized, or the reduced lactose whey under the heading ‘‘Total Solids,’’ or in shall be subjected to pasteurization section 16.196 (dry sample), entitled techniques or its equivalent before use ‘‘Ash—Official Final Action’’ under the in food. heading ‘‘Dried Milk, Nonfat Dry Milk, (c) Reduced lactose whey may be and Malted Milk.’’ used in food in accordance with good (iv) Lactose content, not more than manufacturing practice as indicated in 60 percent—as determined by the meth- § 184.1(b)(1). ods prescribed in section 16.057 (liquid (d) The percent of lactose present on sample), entitled ‘‘Gravimetric Meth- a dry product basis, i.e., ‘‘reduced lac- od—Official Final Action’’ under the tose whey (ll% lactose),’’ shall be de- heading ‘‘Lactose,’’ or in section 31.061 clared on the label of the package sold (dry sample), entitled ‘‘Lane-Eynon to food manufacturers. The percent of General Volumetric Method’’ under the lactose may be declared in 5-percent

586

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00596 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1979b

increments, expressed as a multiple of entitled ‘‘Total Nitrogen—Official 5, not greater than the actual percent- Final Action’’ under the heading age of lactose in the product, or as an ‘‘Total Solids,’’ or in section 16.193 (dry actual percentage provided that an sample), entitled ‘‘Kjeldahl Method’’ analysis of the product on which the under the heading ‘‘Protein—Official actual percentage is based is supplied Final Action.’’ to the food manufacturer. (ii) Fat content, 1 to 4 percent—as de- (e) The presence of reduced lactose termined by the methods prescribed in whey in a finished food product shall be section 16.059 (liquid sample), ‘‘Reese- listed as ‘‘reduced lactose whey.’’ Gottlieb Method [Reference Method] [46 FR 44440, Sept. 4, 1981, as amended at 54 (11)—Official Final Action’’ under the FR 24899, June 12, 1989; 64 FR 1760, Jan. 12, heading ‘‘Fat,’’ or in section 16.199 (dry 1999] sample), entitled ‘‘Fat in Dried Milk (45)—Official Final Action.’’ § 184.1979b Reduced minerals whey. (iii) Ash content, maximum 7 per- (a) Reduced minerals whey is the sub- cent—as determined by the methods stance obtained by the removal of a prescribed in section 16.035 (liquid sam- portion of the minerals from whey. The ple), entitled ‘‘Ash (5)—Official Final dry product shall not contain more Action’’ under the heading ‘‘Total Sol- than 7 percent ash. Reduced minerals ids,’’ or in section 16.196 (dry sample), whey is produced by physical separa- entitled ‘‘Ash—Official Final Action’’ tion techniques such as precipitation, under the heading ‘‘Dried Milk, Nonfat filtration, or dialysis. As with whey, Dry Milk, and Malted Milk.’’ reduced minerals whey can be used as a (iv) Lactose content, maximum 85 fluid, concentrate, or a dry product percent—as determined by the methods form. The acidity of reduced minerals prescribed in section 16.057 (liquid sam- whey may be adjusted by the addi- ple), entitled ‘‘Gravimetric Method— tional of safe and suitable pH-adjusting Official Final Action’’ under the head- ingredients. ing ‘‘Lactose,’’ or in section 31.061 (dry (b) The reduced minerals whey meets sample), entitled ‘‘Lane-Eynon General the following specifications: Volumetric Method’’ under the heading (1) The analysis of reduced minerals whey, on a dry product basis, based on ‘‘Lactose—Chemical Methods—Official analytical methods in the referenced 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 methods 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 INTERNATIONAL, 481 North Frederick section 16.032, entitled ‘‘Method I—Offi- Ave., suite 500, Gaithersburg, MD 20877, cial Final Action’’ under the heading or may be examined at the Center for ‘‘Total Solid.’’ Food Safety and Applied Nutrition’s (vii) Titratable Acidity, variable—as Library, Food and Drug Administra- determined by the methods prescribed tion, 5100 Paint Branch Pkwy., College in section 16.023, entitled ‘‘Acidity (2)— Park, MD 20740, or at the National Ar- Official Final Action’’ under the head- chives and Records Administration ing ‘‘Milk,’’ or by an equivalent poten- (NARA). For information on the avail- tiometric method. ability of this material at NARA, call (2) Limits of impurities are: Heavy 202–741–6030, or go to: http:// metals (as lead). Not more than 10 www.archives.gov/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, 10 to 24 percent— (1996), pp. 760–761, which is incorporated as determined by the methods pre- by reference in accordance with 5 scribed in section 16.036 (liquid sample), U.S.C. 552(a) and 1 CFR part 51. Copies

587

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00597 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1979c 21 CFR Ch. I (4–1–15 Edition)

are available from the National Acad- may be adjusted by the addition of safe emy Press, Box 285, 2101 Constitution and suitable pH-adjusting ingredients. Ave. NW., Washington, DC 20055 (Inter- (b) The whey protein concentrate net address http://www.nap.edu), or may meets the following specifications: be examined at the Center for Food (1) The analysis of whey protein con- Safety and Applied Nutrition’s Li- centrate, on a dry product basis, based brary, Food and Drug Administration, on analytical methods in the ref- 5100 Paint Branch Pkwy., College Park, erenced sections of ‘‘Official Methods MD 20740, or at the National Archives of Analysis of the Association of Offi- and Records Administration (NARA). cial Analytical Chemists,’’ 13th ed. For information on the availability of (1980), which is incorporated by ref- this material at NARA, call 202–741– erence in accordance with 5 U.S.C. 6030, or go to: http://www.archives.gov/ 552(a) and 1 CFR part 51, is given in federallregister/ paragraphs (b)(1)(i) through (b)(1)(vii) code of federal regulations/ l l l of this section. Copies may be obtained ibrllocations.html. from the AOAC INTERNATIONAL, 481 (3) The reduced minerals whey shall North Frederick Ave., suite 500, Gai- be derived from milk that has been pas- thersburg, MD 20877, or may be exam- teurized, or the reduced minerals whey ined at the Center for Food Safety and shall be subjected to pasteurization techniques or its equivalent before use Applied Nutrition’s Library, Food and in food. Drug Administration, 5100 Paint (c) The reduced minerals whey may Branch Pkwy., College Park, MD 20740, be used in food in accordance with good or at the National Archives and manufacturing practice as indicated in Records Administration (NARA). For § 184.1(b)(1). information on the availability of this (d) The percent of minerals present material at NARA, call 202–741–6030, or on a dry product basis, i.e., ‘‘reduced go to: http://www.archives.gov/ minerals whey (ll% minerals),’’ shall federallregister/ be declared on the label of the package codeloflfederallregulations/ sold to food manufacturers. The per- ibrllocations.html. cent of minerals may be declared in 2- (i) Protein content, minimum 25 per- percent increments expressed as a mul- cent—as determined by the methods tiple of 2, not greater than the actual prescribed in section 16.036 (liquid sam- percentage of minerals in the product, ple), entitled ‘‘Total Nitrogen—Offi- or as an actual percentage provided cials Final Action’’ under the heading that an analysis of the product on ‘‘Total Solids,’’ or in section 16.193 (dry which the actual percentage is based is sample), entitled ‘‘Kjeldahl Method’’ supplied to the food manufacturer. under the heading ‘‘Protein—Official (e) The presence of reduced minerals Final Action.’’ whey in a finished food product shall be (ii) Fat content, 1 to 10 percent—as listed as ‘‘reduced minerals whey’’. determined by the methods prescribed [46 FR 44441, Sept. 4, 1981, as amended at 54 in section 16.059 (liquid sample), FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, ‘‘Reese-Gottlieb Method [Reference 1999] Method] (11)—Official Final Action’’ under the heading ‘‘Fat,’’ or in section § 184.1979c Whey protein concentrate. 16.199 (dry sample), entitled ‘‘Fat in (a) Whey protein concentrate is the Dried Milk (45)—Official Final Action.’’ substance obtained by the removal of (iii) Ash content, 2 to 15 percent—as sufficient nonprotein constituents from determined by the methods prescribed whey so that the finished dry product in section 16.035 (liquid sample), enti- contains not less than 25 percent pro- tled ‘‘Ash (5)—Official Final Action’’ tein. Whey protein concentrate is pro- under the heading ‘‘Total Solids,’’ or in duced by physical separation tech- section 16.196 (dry sample), entitled niques such as precipitation, filtration, ‘‘Ash—Official Final Action’’ under the or dialysis. As with whey, whey protein heading ‘‘Dried Milk, Nonfat Dry Milk, concentrate can be used as a fluid, con- and Malted Milk.’’ centrate, or dry product form. The (iv) Lactose content, maximum 60 acidity of whey protein concentrate percent—as determined by the methods

588

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00598 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 184.1983

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- ‘‘Lactose—Chemical Methods—Official percent increments, expressed as a Final Action.’’ multiple of 5, not greater than the ac- (v) Moisture content, 1 to 6 percent— tual percentage of protein in the prod- as determined by the methods pre- uct, or as an actual percentage pro- scribed in section 16.192, entitled vided that an analysis of the product ‘‘Moisture (41)—Official Final Action’’ on which the actual percentage is under the heading ‘‘Dried Milk, Nonfat based is supplied to the food manufac- Dry Milk, and Malted Milk.’’ (vi) Solids content, variable—as de- turer. termined by the methods prescribed in (e) The presence of whey protein con- section 16.032, entitled ‘‘Method I—Offi- centrate in a finished food product cial Final Action’’ under the heading shall be listed as ‘‘whey protein con- ‘‘Total Solids.’’ centrate’’. (vii) Titratable Acidity, variable—as [46 FR 44441, Sept. 4, 1981, as amended at 54 determined by the methods prescribed FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, in section 16.023, entitled ‘‘Acidity (2)— 1999] Official Final Action’’ under the head- ing ‘‘Milk,’’ or by an equivalent poten- § 184.1983 Bakers yeast extract. tiometric method. (a) Bakers yeast extract is the food (2) Limits of impurities are: Heavy ingredient resulting from concentra- metals (as lead). Not more than 10 parts per million (0.001 percent), as de- tion of the solubles of mechanically termined by the method described in ruptured cells of a selected strain of the ‘‘Food Chemicals Codex,’’ 4th ed. yeast, Saccharomyces cerevisiae. It may (1996), pp. 760–761, which is incorporated be concentrated or dried. by reference in accordance with 5 (b) The ingredient meets the fol- U.S.C. 552(a) and 1 CFR part 51. Copies lowing specifications on a dry weight are available from the National Acad- basis: Less than 0.4 part per million emy Press, Box 285, 2101 Constitution (ppm) arsenic, 0.13 ppm cadmium, 0.2 Ave. NW., Washington, DC 20055 (Inter- ppm lead, 0.05 ppm mercury, 0.09 ppm net address http://www.nap.edu), or may selenium, and 10 ppm zinc. be examined at the Center for Food (c) The viable microbial content of Safety and Applied Nutrition’s Li- the finished ingredient as a con- brary, Food and Drug Administration, centrate or dry material is: 5100 Paint Branch Pkwy., College Park, (1) Less than 10,000 organisms/gram MD 20740, or at the National Archives by aerobic plate count. and Records Administration (NARA). (2) Less than 10 yeasts and molds/ For information on the availability of gram. this material at NARA, call 202–741– (3) Negative for Salmonella, E. coli, 6030, or go to: http://www.archives.gov/ coagulase positive Staphylococci, Clos- federallregister/ tridium perfringens, Clostridium botu- codeloflfederallregulations/ linum, or any other recognized micro- ibrllocations.html. (3) The whey protein concentrate bial pathogen or any harmful microbial shall be derived from milk that has toxin. been pasteurized, or the whey protein (d) The ingredient is used as a fla- concentrate shall be subjected to pas- voring agent and adjuvant as defined in teurization techniques or its equiva- § 170.3(o)(12) of this chapter at a level lent before use in food. not to exceed 5 percent in food. (c) The whey protein concentrate (e) This regulation is issued prior to may be used in food in accordance with general evaluation of use of this ingre- good manufacturing practice as indi- dient in order to affirm as GRAS the cated in § 184.1(b)(1). specific use named.

589

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00599 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 184.1984 21 CFR Ch. I (4–1–15 Edition)

§ 184.1984 Zein. Branch Pkwy., College Park, MD 20740, (a) Zein (CAS Reg. No. 9010–66–6) is 240–402–1200, or at the National Ar- one of the components of corn gluten. chives and Records Administration It is produced commercially by extrac- (NARA). For information on the avail- tion from corn gluten with alkaline ability of this material at NARA, call aqueous isopropyl alcohol containing 202–741–6030, or go to: http:// sodium hydroxide. The extract is then www.archives.gov/federallregister/ cooled, which causes the zein to pre- codeloflfederallregulations/ cipitate. ibrllocations.html. (b) The ingredient must be of a pu- (c) In accordance with § 184.1(b)(1), rity suitable for its intended use. the ingredient is used in food with no (c) In accordance with § 184.1(b)(1), limitations other than current good the ingredient is used in food with no manufacturing practice. The affirma- limitation other than current good tion of this ingredient as generally rec- manufacturing practice. The affirma- ognized 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 sur- chapter, as an optional ingredient for face-finishing agent as defined in flavor development in the manufacture § 170.3(o)(30) of this chapter. of cheddar cheese, in accordance with (2) The ingredient is used in food at § 133.113 of this chapter, and in the levels not to exceed current good man- preparation of protein hydrolysates. ufacturing practice. (2) The ingredient is used at levels (d) Prior sanctions for this ingredient not to exceed current good manufac- different from the uses established in turing practice. this section do not exist or have been [60 FR 54193, Oct. 20, 1995, as amended at 78 waived. FR 14667, Mar. 7, 2013] [50 FR 8999, Mar. 6, 1985, as amended at 73 FR 8608, Feb. 14, 2008] PART 186—INDIRECT FOOD SUB- § 184.1985 Aminopeptidase enzyme STANCES AFFIRMED AS GEN- preparation derived from ERALLY RECOGNIZED AS SAFE lactococcus lactis. (a) Aminopeptidase enzyme prepara- Subpart A—General Provisions tion is derived from the nonpathogenic Sec. and nontoxicogenic bacterium 186.1 Substances added indirectly to human Lactococcus lactis (previously named food affirmed as generally recognized as Streptococcus lactis). The preparation safe (GRAS). contains the enzyme aminopeptidase (CAS Reg. No. 9031–94–1; EC 3.4.11.1) and Subpart B—Listing of Specific Substances other peptidases that hydrolyze milk Affirmed as GRAS proteins. The preparation is produced 186.1093 Sulfamic acid. by pure culture fermentation. 186.1256 Clay (kaolin). (b) The ingredient meets the speci- 186.1275 . fications for enzyme preparations in 186.1300 Ferric oxide. the Food Chemicals Codex, 3d ed. (1981), 186.1316 Formic acid. pp. 107–110, which are incorporated by 186.1374 Iron oxides. reference in accordance with 5 U.S.C. 186.1551 Hydrogenated fish oil. 552(a) and 1 CFR part 51. Copies are 186.1555 Japan wax. available from the National Academy 186.1557 Tall oil. Press, 2101 Constitution Ave. NW., 186.1673 Pulp. 186.1750 Sodium chlorite. Washington, DC 20418, or may be exam- 186.1756 Sodium formate. ined at the Office of Food Additive 186.1770 Sodium oleate. Safety (HFS–200), Center for Food Safe- 186.1771 Sodium palmitate. ty and Applied Nutrition, Food and 186.1797 Sodium sulfate. Drug Administration, 5100 Paint 186.1839 Sorbose.

590

VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00600 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR