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Home , Behenic acid

§ 184.1328 21 CFR Ch. I (4–1–11 Edition)

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

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