§ 172.826 21 CFR Ch. I (4–1–12 Edition) § 172.826 Sodium stearyl fumarate. essing, food-packing, or food-storage Sodium stearyl fumarate may be equipment. safely used in food in accordance with [42 FR 14491, Mar. 15, 1977, as amended at 50 the following conditions: FR 3508, Jan. 25, 1985] (a) It contains not less than 99 per- cent sodium stearyl fumarate cal- § 172.829 Neotame. culated on the anhydrous basis, and (a) Neotame is the chemical N-[N- not more than 0.25 percent sodium ste- (3,3-dimethylbutyl)-L-a-aspartyl]-L- aryl maleate. phenylalanine-1-methyl ester (CAS (b) The additive is used or intended Reg. No. 165450–17–9). for use: (1) As a dough conditioner in yeast- (b) Neotame meets the following leavened bakery products in an amount specifications when it is tested accord- not to exceed 0.5 percent by weight of ing to the methods described or ref- the flour used. erenced in the document entitled (2) As a conditioning agent in dehy- ‘‘Specifications and Analytical Meth- drated potatoes in an amount not to ods for Neotame’’ dated April 3, 2001, exceed 1 percent by weight thereof. by the NutraSweet Co., 699 North (3) As a stabilizing agent in Wheeling Rd., Mount Prospect, IL nonyeast-leavened bakery products in 60056. The Director of the Office of the an amount not to exceed 1 percent by Federal Register has approved the in- weight of the flour used. corporation by reference of this mate- (4) As a conditioning agent in proc- rial in accordance with 5 U.S.C. 552(a) essed cereals for cooking in an amount and 1 CFR part 51. Copies are available not to exceed 1 percent by weight of from the Office of Food Additive Safety the dry cereal, except for foods for (HFS–200), Center for Food Safety and which standards of identity preclude Applied Nutrition, 5100 Paint Branch such use. Pkwy., College Park, MD 20740. Copies (5) As a conditioning agent in starch- may be examined at the Center for thickened or flour-thickened foods in Food Safety and Applied Nutrition’s an amount not to exceed 0.2 percent by Library, 5100 Paint Branch Pkwy., rm. weight of the food. 1C–100, College Park, MD 20740, or at the National Archives and Records Ad- § 172.828 Acetylated monoglycerides. ministration (NARA). For information The food additive acetylated on the availability of this material at monoglycerides may be safely used in NARA, call 202–741–6030, or go to: http:// or on food in accordance with the fol- www.archives.gov/federallregister/ lowing prescribed conditions: codeloflfederallregulations/ (a) The additive is manufactured by: ibrllocations.html. (1) The interesterification of edible (1) Assay for neotame, not less than fats with triacetin and in the presence 97.0 percent and not more than 102.0 of catalytic agents that are not food percent on a dry basis. additives or are authorized by regula- (2) Free dipeptide acid (N-[N-(3,3- tion, followed by a molecular distilla- dimethylbutyl)-L-a-aspartyl]-L- tion or by steam stripping; or phenylalanine), not more than 1.5 per- (2) The direct acetylation of edible cent. monoglycerides with acetic anhydride (3) Other related substances, not without the use of catalyst or molec- more than 2.0 percent. ular distillation, and with the removal (4) Lead, not more than 2.0 milli- by vacuum distillation, if necessary, of the acetic acid, acetic anhydride, and grams per kilogram. triacetin. (5) Water, not more than 5.0 percent. (b) The food additive has a Reichert- (6) Residue on ignition, not more Meissl value of 75–200 and an acid value than 0.2 percent of less than 6. (7) Specific rotation, determined at (c) The food additive is used at a 20 °C [a]D: ¥40.0° to 43.4° calculated on level not in excess of the amount rea- a dry basis. sonably required to produce its in- (c) The food additive neotame may be tended effect in food, or in food-proc- safely used as a sweetening agent and 88 VerDate Mar<15>2010 10:14 May 14, 2012 Jkt 226069 PO 00000 Frm 00098 Fmt 8010 Sfmt 8010 Y:\SGML\226069.XXX 226069 erowe on DSK2VPTVN1PROD with CFR Food and Drug Administration, HHS § 172.832 flavor enhancer in foods generally, ex- (b) The additive meets the specifica- cept in meat and poultry, in accord- tions of the ‘‘Food Chemicals Codex,’’ ance with current good manufacturing 4th ed. (1996), pp. 398–400, which is in- practice, in an amount not to exceed corporated by reference in accordance that reasonably required to accomplish with 5 U.S.C. 552(a) and 1 CFR part 51. the intended technical effect, in foods Copies are available from the Division for which standards of identity estab- of Product Policy (HFS–206), Center for lished under section 401 of the Federal Food Safety and Applied Nutrition, Food, Drug, and Cosmetic Act do not Food and Drug Administration, 5100 preclude such use. Paint Branch Pkwy., College Park, MD (d) When neotame is used as a sugar 20740, or may be examined at the Cen- substitute tablet, L-leucine may be ter for Food Safety and Applied Nutri- used as a lubricant in the manufacture tion’s Library, 5100 Paint Branch of tablets at a level not to exceed 3.5 Pkwy., College Park, MD 20740, or at percent of the weight of the tablet. the National Archives and Records Ad- (e) If the food containing the additive ministration (NARA). For information purports to be or is represented to be on the availability of this material at for special dietary use, it shall be la- NARA, call 202–741–6030, or go to: http:// beled in compliance with part 105 of www.archives.gov/federallregister/ this chapter. codeloflfederallregulations/ [67 FR 45310, July 9, 2002] ibrllocations.html. (c) The additive may be used as a § 172.830 Succinylated monoglycerides. sweetener in foods generally, in accord- The food additive succinylated ance with current good manufacturing monoglycerides may be safely used in practice in an amount not to exceed food in accordance with the following that reasonably required to accomplish prescribed conditions: the intended effect. (a) The additive is a mixture of semi- (d) If the food containing the additive and neutral succinic acid esters of purports to be or is represented to be mono- and diglycerides produced by the for special dietary use, it shall be la- succinylation of a product obtained by beled in compliance with part 105 of the glycerolysis of edible fats and oils, this chapter. or by the direct esterification of glyc- [63 FR 16433, Apr. 3, 1998, as amended at 64 erol with edible fat-forming fatty FR 43909, Aug. 12, 1999] acids. (b) The additive meets the following § 172.832 Monoglyceride citrate. specifications: A food additive that is a mixture of Succinic acid content: 14.8%–25.6% glyceryl monooleate and its citric acid Melting point: 50 °C–60 °C. monoester manufactured by the reac- Acid number: 70–120 tion of glyceryl monooleate with citric (c) The additive is used or intended acid under controlled conditions may for use in the following foods: be safely used as a synergist and solu- (1) As an emulsifier in liquid and bilizer for antioxidants in oils and fats, plastic shortenings at a level not to ex- when used in accordance with the con- ceed 3 percent by weight of the short- ditions prescribed in this section. ening. (a) The food additive meets the fol- (2) As a dough conditioner in bread lowing specifications: baking, when such use is permitted by an appropriate food standard, at a level Acid number, 70–100. not to exceed 0.5 percent by weight of Total citric acid (free and combined), 14 per- cent–17 percent. the flour used. (b) It is used, or intended for use, in § 172.831 Sucralose. antioxidant formulations for addition (a) Sucralose is the chemical 1,6- to oils and fats whereby the additive dichloro-1,6-dideoxy-b-D- does not exceed 200 parts per million of fructofuranosyl-4-chloro-4-deoxy-a-D- the combined weight of the oil or fat galactopyranoside (CAS Reg. No. 56038– and the additive. 13–2). (c) To assure safe use of the additive: 89 VerDate Mar<15>2010 10:14 May 14, 2012 Jkt 226069 PO 00000 Frm 00099 Fmt 8010 Sfmt 8010 Y:\SGML\226069.XXX 226069 erowe on DSK2VPTVN1PROD with CFR.