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Home , Behenic acid

Food and Drug Administration, HHS § 184.1328

(d) Prior sanctions for this ingredient glyceryl esters of fatty acids present in different from the uses established in commercial . Glyceryl this section do not exist or have been monostearate is prepared by waived. glycerolysis of certain fats or oils that [50 FR 8998, Mar. 6, 1985, as amended at 73 FR are derived from edible sources or by 8607, Feb. 14, 2008] esterification, with glycerin, of stearic acid that is derived from edible § 184.1323 Glyceryl monooleate. sources. (a) Glyceryl monooleate is prepared (b) The ingredient must be of a pu- by esterification of commerical oleic rity suitable for its intended use. acid that is derived either from edible (c) In accordance with § 184.1(b)(1), sources or from tall oil fatty acids the ingredient is used in food with no meeting the requirements of § 172.862 of limitation other than current good this chapter. It contains glyceryl manufacturing practice. monooleate (C21H40O4, CAS Reg. No. (d) Prior sanctions for this ingredient 25496–72–4) and glyceryl esters of fatty different from the uses established in acids present in commercial . this section do not not exist or have (b) The ingredient must be of a pu- been waived. rity suitable for its intended use. (c) In accordance with § 184.1(b)(1), [54 FR 7403 Feb. 21, 1989, as amended at 73 FR the ingredient is used in food with no 8607, Feb. 14, 2008] limitation other than current good manufacturing practice. The affirma- § 184.1328 . tion of this ingredient as generally rec- (a) Glyceryl behenate is a mixture of ognized as safe (GRAS) as a direct glyceryl esters of behenic acid made human food ingredient is based upon from glycerin and behenic acid (a satu- the following current good manufac- rated C22 ). The mixture con- turing practice conditions of use: tains predominately glyceryl (1) The ingredient is used as a fla- dibehenate. voring agent and adjuvant as defined in (b) The ingredient meets the fol- § 170.3(o)(12) of this chapter and as a lowing specifications: solvent and vehicle as defined in (1) 10 to 20 percent , 47 § 170.3(o)(27) of this chapter. to 59 percent , 26 to 38 per- (2) The ingredient is used in the fol- cent , and not more than lowing foods at levels not to exceed 2.5 percent free fatty acids. current good manufacturing practice: (2) Behenic acid. Between 80 and 90 baked goods and baking mixes as de- fined in § 170.3(n)(1) of this chapter; percent of the total fatty acid content. nonalcoholic beverages and beverage (3) Acid value. Not more than 4. bases as defined in § 170.3(n)(3) of this (4) Saponification value. Between 145 chapter; chewing gum as defined in and 165. § 170.3(n)(6) of this chapter; and meat (5) Iodine number. Not more than 3. products as defined in § 170.3(n)(29) of (6) Heavy metals (as Pb). Not more this chapter. than 10 parts per million. (d) Prior sanctions for this ingredient (c) In accordance with § 184.1(b)(1) of different from the use established in this chapter, the ingredient is used in this section do not exist or have been food with no limitation other than cur- waived. 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 529

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