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21 CFR Ch. I (4–1–99 Edition) § 184.1324

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21 CFR Ch. I (4–1–99 Edition) § 184.1324 § 184.1324 21 CFR Ch. I (4±1±99 Edition) § 184.1324 Glyceryl monostearate. direct human food ingredient is based (a) Glyceryl monostearate, also upon the following current good manu- known as monostearin, is a mixture of facturing practice conditions of use: (1) The ingredient is used as a formu- variable proportions of glyceryl mono- lation aid, as defined in § 170.3(o)(14) of stearate (C H O CAS Reg. No. 31566± 21 42 4, this chapter. 31±1), glyceryl monopalmitate (2) The ingredient is used in excipient (C H O CAS Reg. No. 26657±96±5) and 19 38 4, 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 glycerolysis of certain fats or oils that [52 FR 42430, Nov. 5, 1987] are derived from edible sources or by esterification, with glycerin, of stearic § 184.1329 Glyceryl palmitostearate. acid that is derived from edible (a) Glyceryl palmitostearate is a sources. mixture of mono-, di-, and triglyceryl (b) FDA is developing food-grade esters of palmitic and stearic acids specifications for glyceryl monostea- made from glycerin, palmitic acid, and rate in cooperation with the National stearic acid. Academy of Sciences. In the interim, (b) The ingredient meets the fol- this ingredient must be of a purity lowing specifications: suitable for its intended use. (1) The substance is a mixture of (c) In accordance with § 184.1(b)(1), mono-, di-, and triglycerides of pal- the ingredient is used in food with no mitic acid and stearic acid. limitation other than current good (2) Heavy metals (as lead): Not more manufacturing practice. than 10 parts per million. (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 not exist or have limitation other than current good been waived. manufacturing practice. The affirma- tion of this ingredient as generally rec- [54 FR 7403 Feb. 21, 1989] ognized as safe (GRAS) as a direct § 184.1328 Glyceryl behenate. human food ingredient is based upon the following current good manufac- (a) Glyceryl behenate is a mixture of turing practice conditions of use: glyceryl esters of behenic acid made (1) The ingredient is used as a formu- from glycerin and behenic acid (a satu- lation aid, as defined in § 170.3(o)(14) of rated C22 fatty acid). The mixture con- this chapter. tains predominately glyceryl (2) The ingredient is used in excipient dibehenate. formulations for use in tablets at levels (b) The ingredient meets the fol- not to exceed good manufacturing lowing specifications: practice. (1) 10 to 20 percent monoglyceride, 47 to 59 percent diglyceride, 26 to 38 per- [60 FR 63621, Dec. 12, 1995] cent triglyceride, and not more than 2.5 percent free fatty acids. § 184.1330 Acacia (gum arabic). (2) Behenic acid. Between 80 and 90 (a) Acacia (gum arabic) is the dried percent of the total fatty acid content. gummy exudate from stems and (3) Acid value. Not more than 4. branches of trees of various species of (4) Saponification value. Between 145 the genus Acacia, family Leguminosae. and 165. (b) The ingredient meets the speci- (5) Iodine number. Not more than 3. fications of the ``Food Chemicals (6) Heavy metals (as Pb). Not more Codex,'' 3d Ed. (1981), p. 7, which is in- than 10 parts per million. corporated by reference. Copies may be (c) In accordance with § 184.1(b)(1) of obtained from the National Academy this chapter, the ingredient is used in Press, 2101 Constitution Ave. NW., food with no limitation other than cur- Washington, DC 20418, or may be exam- rent good manufacturing practice. The ined at the Office of the Federal Reg- affirmation of this ingredient is gen- ister, 800 North Capitol Street, NW., erally recognized as safe (GRAS) as a suite 700, Washington, DC 20408. 486 VerDate 06<MAY>99 09:09 May 12, 1999 Jkt 183064 PO 00000 Frm 00482 Fmt 8010 Sfmt 8010 Y:\SGML\183064T.XXX pfrm03 PsN: 183064T.
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