Food and Drug Administration, HHS § 184.1295

NARA, call 202–741–6030, or go to: http:// in this section do not exist or have www.archives.gov/federallregister/ been waived. codeloflfederallregulations/ [52 FR 25976, July 10, 1987, as amended at 73 ibrllocations.html. FR 8607, Feb. 14, 2008] (c) Dill and its derivatives are used as flavoring agents and adjuvants as de- § 184.1293 Ethyl alcohol. fined in § 170.3(o)(12) of this chapter. (d) The ingredients are used in food (a) Ethyl alcohol (ethanol) is the at levels not to exceed good manufac- chemical C2H5OH. turing practice. (b) The ingredient meets the speci- (e) [Reserved] fications of the ‘‘Food Chemicals (f) Prior sanctions for these ingredi- Codex,’’ 4th ed. (1996), p. 136, which is ents different from the uses established incorporated by reference in accord- in this section do not exist or have ance with 5 U.S.C. 552(a) and 1 CFR been waived. part 51. Copies are available from the National Academy Press, Box 285, 2101 [42 FR 14653, Mar. 15, 1977, as amended at 42 Constitution Ave. NW., Washington, FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, DC 20055 (Internet address http:// 1984; 64 FR 1760, Jan. 12, 1999] www.nap.edu), or may be examined at § 184.1287 Enzyme-modified fats. the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Ad- (a) Enzyme-modified refined beef fat, ministration, 5100 Paint Branch Pkwy., enzyme-modified butterfat, and en- College Park, MD 20740, or at the Na- zyme-modified steam-rendered chicken tional Archives and Records Adminis- fat are prepared from refined beef fat; tration (NARA). For information on butterfat or milkfat; and steam-ren- the availability of this material at dered chicken fat, respectively, with NARA, call 202–741–6030, or go to: http:// enzymes that are generally recognized www.archives.gov/federallregister/ as safe (GRAS). Enzyme-modified milk codeloflfederallregulations/ powder may be prepared with GRAS ibrllocations.html. enzymes from reconstituted milk pow- (c) The ingredient is used as an anti- der, whole milk, condensed or con- microbial agent as defined in centrated whole milk, evaporated § 170.3(o)(2) of this chapter on pizza milk, or milk powder. The lipolysis is crusts prior to final baking at levels maintained at a temperature that is not to exceed 2.0 percent by product optimal for the action of the enzyme weight. until appropriate acid development is attained. The enzymes are then inac- (d) This regulation is issued prior to tivated. The resulting product is con- general evaluation of use of this ingre- centrated or dried. dient in order to affirm as GRAS the specific use named. (b) The ingredients must be of a pu- rity suitable for their intended use. [42 FR 14653, Mar. 15, 1977, as amended at 49 (c) In accordance with § 184.1(b)(1), FR 5612, Feb. 14, 1984; 64 FR 1760, Jan. 12, the ingredients are used in food with 1999] no limitation other than current good manufacturing practice. The affirma- § 184.1295 Ethyl formate.

tion of these ingredients as generally (a) Ethyl formate (C3H6O2, CAS Reg. recognized as safe (GRAS) as direct No. 109–94–4) is also referred to as ethyl human food ingredients is based upon methanoate. It is an ester of formic the following current good manufac- acid and is prepared by esterification turing practice conditions of use: of formic acid with ethyl alcohol or by (1) The ingredients are used as fla- distillation of ethyl acetate and formic voring agents and adjuvants as defined acid in the presence of concentrated in § 170.3(o)(12) of this chapter. sulfuric acid. Ethyl formate occurs (2) The ingredients are used in food naturally in some plant oils, fruits, and at levels not to exceed current good juices but does not occur naturally in manufacturing practice. the animal kingdom. (d) Prior sanctions for these ingredi- (b) The ingredient meets the speci- ents different from the uses established fications of the ‘‘Food Chemicals

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Codex,’’ 3d Ed. (1981), p. 376, which is in- (2) Ferric ammonium citrate (iron corporated by reference. Copies may be (III) ammonium citrate, CAS Reg. No. obtained from the National Academy 1333–00–2) is a complex salt of undeter- Press, 2101 Constitution Ave. NW., mined structure composed of 14.5 to 16 Washington, DC 20418, or may be exam- percent iron, approximately 7.5 percent ined at the National Archives and ammonia, and 75 percent citric acid Records Administration (NARA). For and occurs as thin transparent green information on the availability of this scales, as granules, as a powder, or as material at NARA, call 202–741–6030, or transparent green crystals. go to: http://www.archives.gov/ (b) The ingredients meet the speci- federallregister/ fications of the Food Chemicals Codex, codeloflfederallregulations/ 3d Ed. (1981), pp. 116–117 (Ferric ammo- ibrllocations.html. nium citrate, brown) and p. 117 (Ferric (c) The ingredient is used as a fla- ammonium citrate, green), which is in- voring agent and adjuvant as defined in corporated by reference. Copies are § 170.3(o)(12) of this chapter. available from the National Academy (d) The ingredient is used in food at Press, 2101 Constitution Ave. NW., levels not to exceed good manufac- Washington, DC 20418, or available for turing practice in accordance with inspection at the National Archives § 184.1(b)(1). Current good manufac- and Records Administration (NARA). turing practice results in a maximum For information on the availability of level, as served, of 0.05 percent in baked this material at NARA, call 202–741– goods as defined in § 170.3(n)(1) of this 6030, or go to: http://www.archives.gov/ chapter; 0.04 percent in chewing gum as federallregister/ defined in § 170.3(n)(6), hard candy as codeloflfederallregulations/ defined in § 170.3(n)(25), and soft candy ibrllocations.html. as defined in § 170.3(n)(38) of this chap- (c) In accordance with § 184.1(b)(1), ter; 0.02 percent in frozen dairy des- the ingredients are used in food as nu- serts as defined in § 170.3(n)(20) of this trient supplements as defined in chapter; 0.03 percent in gelatins, pud- § 170.3(o)(20) of this chapter, with no dings, and fillings as defined in limitation other than current good § 170.3(n)(22) of this chapter; and 0.01 manufacturing practice. The ingredi- percent in all other food categories. ents may also be used in infant formula (e) Prior sanctions for ethyl formate in accordance with section 412(g) of the different from the uses established in Federal Food, Drug, and Cosmetic Act this section do not exist or have been (the act) (21 U.S.C. 350a(g)) or with reg- waived. ulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). [45 FR 22915, Apr. 4, 1980, as amended at 49 (d) Prior sanctions for these ingredi- FR 5612, Feb. 14, 1984] ents different from the uses established § 184.1296 Ferric ammonium citrate. in this section do not exist or have been waived. (a) Ferric ammonium citrate (iron (III) ammonium citrate) is prepared by [53 FR 16864, May 12, 1988] the reaction of ferric hydroxide with citric acid, followed by treatment with § 184.1297 Ferric chloride. ammonium hydroxide, evaporating, (a) Ferric chloride (iron (III) chlo- and drying. The resulting product oc- ride, FeC13, CAS Reg. No. 7705–08–0) curs in two forms depending on the may be prepared from iron and chlorine stoichiometry of the initial reactants. or from ferric oxide and hydrogen chlo- (1) Ferric ammonium citrate (iron ride. The pure material occurs as (III) ammonium citrate, CAS Reg. No. hydroscopic, hexagonal, dark crystals. 1332–98–5) is a complex salt of undeter- Ferric chloride hexahydrate (iron (III) mined structure composed of 16.5 to chloride hexahydrate, FeC13. 6H20, CAS 18.5 percent iron, approximately 9 per- Reg. No. 10025–77–1) is readily formed cent ammonia, and 65 percent citric when ferric chloride is exposed to mois- acid and occurs as reddish brown or ture. garnet red scales or granules or as a (b) The ingredient must be of a pu- brownish-yellowish powder. rity suitable for its intended use.

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