Food and Drug Administration, HHS § 184.1865

human food ingredient is based upon or enzymes, followed by refinement and the following current good manufac- crystallization from the resulting hy- turing practice conditions of use: drolysate. (1) The ingredient is used as an anti- (b) The ingredient meets the speci- oxidant as defined in § 170.3(o)(3) of this fications of the Food Chemicals Codex, chapter; an emulsifier and emulsifier 3d Ed. (1981), pp. 97–98 under the head- salt as defined in § 170.3(o)(8) of this ing ‘‘Dextrose,’’ which is incorporated chapter; a sequestrant as defined in by reference in accordance with 5 § 170.3(o)(26) of this chapter; and a sur- U.S.C. 552(a) and 1 CFR part 1. Copies face-active agent as defined in are available from the National Acad- § 170.3(o)(29) of this chapter. emy Press, 2101 Constitution Ave., NW., (2) The ingredient is used in mar- Washington, DC 20418, or available for garine in accordance with § 166.110 of inspection at the National Archives this chapter; in nonalcoholic beverages and Records Administration (NARA). as defined in § 170.3(n)(3) of this chap- For information on the availability of ter; and in fats and oils as defined in this material at NARA, call 202–741– § 170.3(n)(12) of this chapter at levels 6030, or go to: http://www.archives.gov/ not to exceed current good manufac- federallregister/ turing 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, or different from those set the ingredient is used in food with no forth in part 181 of this chapter, do not limitation other than current good exist or have been waived. manufacturing practice. (d) Prior sanctions for this ingredient [59 FR 63897, Dec. 12, 1994, as amended at 73 FR 8608, Feb. 14, 2008] different from the uses established in this section do not exist or have been § 184.1854 Sucrose. waived.

(a) Sucrose (C12H22O11, CAS Reg. No. [53 FR 44876, Nov. 7, 1988] 57–50–11–1) sugar, cane sugar, or beet sugar is the chemical b-D- § 184.1859 Invert sugar. fructofuranosyl-a-D-glucopyranoside. (a) Invert sugar (CAS Reg. No. 8013– Sucrose is obtained by crystallization 17–0) is an aqueous solution of inverted from sugar cane or sugar beet juice or partly inverted, refined or partly re- that has been extracted by pressing or fined sucrose, the solids of which con- diffusion, then clarified and evapo- tain not more than 0.3 percent by rated. weight of ash. The solution is colorless, (b) The ingredient must be of a pu- odorless, and flavorless, except for rity suitable for its intended use. sweetness. It is produced by the hydrol- (c) In accordance with § 184.1(b)(1), ysis or partial hydrolysis of sucrose the ingredient is used in food with no with safe and suitable acids or en- limitation other than current good zymes. manufacturing practice. (b) The ingredient must be of a pu- (d) Prior sanctions for this ingredient rity suitable for its intended use. 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. [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, 1989, as amended at 73 FR 8608, Feb. 14, 2008] (d) Prior sanctions for this ingredient different from the uses established in § 184.1857 Corn sugar. this section do not exist or have been waived. (a) Corn sugar (C6H12O6, CAS Reg. No. 50–99–7), commonly called D-glucose or [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, dextrose, is the chemical a-D- 1989, as amended at 73 FR 8608, Feb. 14, 2008] glucopyranose. It occurs as the anhy- drous or the monohydrate form and is § 184.1865 Corn syrup. produced by the complete hydrolysis of (a) Corn syrup, commonly called corn starch with safe and suitable acids ‘‘glucose sirup’’ or ‘‘glucose syrup,’’ is

573

VerDate Nov<24>2008 14:38 May 05, 2009 Jkt 217067 PO 00000 Frm 00583 Fmt 8010 Sfmt 8010 Y:\SGML\217067.XXX 217067 cprice-sewell on PRODPC61 with CFR § 184.1866 21 CFR Ch. I (4–1–09 Edition)

obtained by partial hydrolysis of corn go to: http://www.archives.gov/ starch with safe and suitable acids or federallregister/ enzymes. It may also occur in the de- codeloflfederallregulations/ hydrated form (dried glucose sirup). ibrllocations.html. Depending on the degree of hydrolysis, (c) In accordance with § 184.1(b)(1), corn syrup may contain, in addition to the ingredient is used in food with no glucose, maltose and higher limitation other than current good saccharides. manufacturing practice. (b) The ingredient meets the speci- [61 FR 43450, Aug.23, 1996] fications as defined and determined in § 168.120(b) or § 168.121(a) of this chapter, § 184.1875 Thiamine hydrochloride. as appropriate. (a) Thiamine hydrochloride (c) In accordance with § 184.1(b)(1), (C H C1N OS·HCl, CAS Reg. No. 67–03– the ingredient is used in food with no 12 17 4 8) is the chloride-hydrochloride salt of limitation other than current good thiamine. It occurs as hygroscopic manufacturing practice. (d) Prior sanctions for this ingredient white crystals or a white crystalline different from the uses established in powder. The usual method of preparing this section do not exist or have been this substance is by linking the waived. preformed thiazole and pyrimidine ring systems. [53 FR 44876, Nov. 7, 1988, as amended at 73 (b) The ingredient meets the speci- FR 8608, Feb. 14, 2008] fications of the Food Chemicals Codex, 3d Ed. (1981), p. 324, which is incor- § 184.1866 High fructose corn syrup. porated by reference. Copies are avail- (a) High fructose corn syrup, a sweet, able from the National Academy Press, nutritive saccharide mixture con- 2101 Constitution Ave. NW., Wash- taining either approximately 42 or 55 ington, DC 20418, or available for in- percent fructose, is prepared as a clear spection at the National Archives and aqueous solution from high dextrose- Records Administration (NARA). For equivalent corn starch hydrolysate by information on the availability of this partial enzymatic conversion of glu- material at NARA, call 202–741–6030, or cose (dextrose) to fructose using an in- go to: http://www.archives.gov/ soluble glucose isomerase enzyme prep- federallregister/ aration described in § 184.1372. The codeloflfederallregulations/ product containing more than 50 per- ibrllocations.html. cent fructose (dry weight) is prepared (c) In accordance with § 184.1(b)(1), through concentration of the fructose the ingredient is used in food with no portion of the mixture containing less limitation other than current good than 50 percent fructose. manufacturing practice. The affirma- (b) The ingredient shall conform to tion of this ingredient as generally rec- the identity and specifications listed in ognized as safe (GRAS) as a direct the monograph entitled ‘‘High-Fruc- human food ingredient is based upon tose Corn Syrup’’ in the Food Chemi- the following current good manufac- cals Codex, 4th ed. (1996), pp. 191–192, turing practice conditions of use: which is incorporated by reference in (1) The ingredient is used as a fla- accordance with 5 U.S.C. 552(a) and 1 voring agent and adjuvant as defined in CFR part 51. Copies are available from § 170.3(o)(12) of this chapter or as a nu- the Office of Premarket Approval, Cen- trient supplement as defined in ter for Food Safety and Applied Nutri- § 170.3(o)(20) of this chapter. tion (HFS–200), Food and Drug Admin- (2) The ingredient is used in food at istration, 5100 Paint Branch Pkwy., levels not to exceed current good man- College Park, MD 20740, or may be ex- ufacturing practice. Thiamine hydro- amined at the Center for Food Safety chloride may be used in infant formula and Applied Nutrition’s Library, 5100 in accordance with section 412(g) of the Paint Branch Pkwy., College Park, MD Federal Food, Drug, and Cosmetic Act 20740, or at the National Archives and (the Act) or with regulations promul- Records Administration (NARA). For gated under section 412(a)(2) of the Act. information on the availability of this (d) Prior sanctions for this ingredient material at NARA, call 202–741–6030, or different from the uses established in

574

VerDate Nov<24>2008 14:38 May 05, 2009 Jkt 217067 PO 00000 Frm 00584 Fmt 8010 Sfmt 8010 Y:\SGML\217067.XXX 217067 cprice-sewell on PRODPC61 with CFR