§ 184.1866 21 CFR Ch. I (4–1–12 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

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