Food and Drug Administration, HHS § 184.1260

Ave. NW., Washington, DC 20055 (Inter- information on the availability of this net address http://www.nap.edu), or may material at NARA, call 202–741–6030, or be examined at the Center for Food go to: http://www.archives.gov/ Safety and Applied Nutrition’s Li- federallregister/ brary, Food and Drug Administration, codeloflfederallregulations/ 5100 Paint Branch Pkwy., College Park, ibrllocations.html. MD 20740, or at the National Archives (9) Hexane—not more than 5 parts per and Records Administration (NARA). million as determined by the method of For information on the availability of Dupuy et al., ‘‘Rapid Quantitative De- this material at NARA, call 202–741– termination of Residual Hexane in Oils 6030, or go to: http://www.archives.gov/ by Direct Gas Chromatography,’’ pub- federallregister/ lished in the ‘‘Journal of the American code of federal regulations/ l l l Oil Chemists’ Society,’’ Vol. 52, p. 118– ibrllocations.html. 120, 1975, which is incorporated by ref- (4) Color—clear, bright, and free from erence. Copies are available from the suspended matter. (5) Odor and taste—free from foreign Division of Food and Color Additives, and rancid odor and taste. Center for Food Safety and Applied Nu- (6) Residual catalyst (‘‘Official Meth- trition (HFS–200), Food and Drug Ad- ods of Analysis of the Association of ministration, 5100 Paint Branch Pkwy., Official Analytical Chemists,’’ 13th Ed. College Park, MD 20740, or available for (1980), sections 25.049–25.055, which is inspection at the National Archives incorporated by reference), residual and Records Administration (NARA). fluorine; limit of detection 0.2 part per For information on the availability of million F; multiply fluoride result by this material at NARA, call 202–741– 2.63 to convert to residual catalyst. 6030, or go to: http://www.archives.gov/ Copies of the material incorporated by federallregister/ reference may be obtained from the codeloflfederallregulations/ AOAC INTERNATIONAL, 481 North ibrllocations.html. Frederick Ave., suite 500, Gaithersburg, (c) In accordance with § 184.1(b)(1), MD 20877, or may be examined at the the ingredient is used in the following National Archives and Records Admin- food categories at levels not to exceed istration (NARA). For information on current good manufacturing practice: the availability of this material at Confections and frostings as defined in NARA, call 202–741–6030, or go to: http:// § 170.3(n)(9) of this chapter; coatings of www.archives.gov/federallregister/ soft candy as defined in § 170.3(n)(38) of codeloflfederallregulations/ this chapter; and sweet sauces and top- ibrllocations.html. The ingredient shall pings as defined in § 170.3(n)(43) of this be washed three times in batches with chapter; except that the ingredient 0.5 percent sodium bicarbonate to re- may not be used in a standardized food move catalyst residuals in accordance unless permitted by the standard of with good manufacturing practice. identity. (7) Residual methanol—5 parts per (d) The ingredient is used in food in million maximum. accordance with § 184.1(b)(1) at levels (8) Residual fatty acid ethyl esters— not to exceed good manufacturing not more than 20 parts per million as practice. determined by a ‘‘Modification of Japan Institute of Oils and Fats: Anal- [43 FR 54239, Nov. 11, 1978, as amended at 47 ysis Method of Residual Ethyl Esters of FR 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, Fatty Acids’’ issued by the Fuji Oil 1984; 49 FR 22799, June 1, 1984; 52 FR 47920, Co., which is incorporated by reference. Dec. 17, 1987; 52 FR 48905, Dec. 28, 1987; 61 FR Copies are available from the Division 36290, July 10, 1996; 64 FR 1760, Jan. 12, 1999] of Food and Color Additives, Center for § 184.1260 Copper gluconate. Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra- (a) Copper gluconate (cupric gluco- tion, 5100 Paint Branch Pkwy., College nate (CH2OH(CHOH)4COO)2Cu, CAS Park, MD 20740, or available for inspec- Reg. No. 527–09–3) is a substance that tion at the National Archives and occurs as light blue to bluish-green, Records Administration (NARA). For odorless crystals, or as a fine, light

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blue powder. It is prepared by the reac- (c) In accordance with § 184.1(b)(1), tion of gluconic acid solutions with cu- the ingredient is used in food with no pric oxide or basic cupric carbonate. limitation other than current good (b) The ingredient meets the speci- manufacturing practice. The affirma- fications of the Food Chemicals Codex, tion of this ingredient as generally rec- 3d Ed. (1981), p. 90, which is incor- ognized as safe (GRAS) as a direct porated by reference. Copies are avail- human food ingredient is based upon able from the National Academy Press, the following current good manufac- 2101 Constitution Ave. NW., Wash- turing practice conditions of use: ington, DC. 20418, or available for in- (1) The ingredient is used as a nutri- spection at the National Archives and ent supplement as defined in Records Administration (NARA). For § 170.3(o)(20) of this chapter and as a information on the availability of this processing aid as defined in § 170.3(o)(24) material at NARA, call 202–741–6030, or of this chapter. go to: http://www.archives.gov/ (2) The ingredient is used in food at federallregister/ levels not to exceed current good man- codeloflfederallregulations/ ufacturing practice. Copper sulfate ibrllocations.html. may be used in infant formula in ac- (c) In accordance with § 184.1(b)(1), cordance with section 412(g) of the Fed- the ingredient is used in food with no eral Food, Drug, and Cosmetic Act (the limitation other than current good Act) or with regulations promulgated manufacturing practice. The affirma- under section 412(a)(2) of the Act. tion of this ingredient as generally rec- (d) Prior sanctions for this ingredient ognized as safe (GRAS) as a direct different from the uses established in human food ingredient is based upon this section do not exist or have been the following current good manufac- waived. turing practice conditions of use: (1) The ingredient is used as a nutri- [49 FR 24119, June 12, 1984, as amended at 73 ent supplement as defined in FR 8607, Feb. 14, 2008; 76 FR 59249, Sept. 26, 2011] § 170.3(o)(20) of this chapter and as a synergist as defined in § 170.3(o)(31) of § 184.1262 Corn silk and corn silk ex- this chapter. tract. (2) The ingredient is used in food at (a) Corn silk is the fresh styles and levels not to exceed current good man- stigmas of Zea mays L. collected when ufacturing practice. Copper gluconate the corn is in milk. The filaments are may be used in infant formula in ac- extracted with dilute ethanol to cordance with section 412(g) of the Fed- produce corn silk extract. The extract eral Food, Drug, and Cosmetic Act (the may be concentrated at a temperature Act) or with regulations promulgated not exceeding 60 °C. under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient (b) The ingredient must be of a pu- different from the uses established in rity suitable for its intended use. this section do not exist or have been (c) In accordance with § 184.1(b)(2), waived. the ingredients are used in food only within the following specific limita- [49 FR 24119, June 12, 1984] tions:

§ 184.1261 Copper sulfate. Maximum level of (a) Copper sulfate (cupric sulfate, Category of food use in Functional use food (as CuSO4·5 H2O, CAS Reg. No. 7758–99–8) served) 1 usually is used in the pentahydrate form. This form occurs as large, deep Baked goods and bak- 30 Flavoring agent, blue or ultramarine, triclinic crystals; ing mixes, § 170.3(o)(12) of this § 170.3(n)(1) of this chapter. as blue granules, or as a light blue pow- chapter. der. The ingredient is prepared by the Nonalcoholic bev- 20 Do. reaction of sulfuric acid with cupric erages, § 170.3(n)(3) oxide or with copper metal. of this chapter. Frozen dairy desserts, 10 Do. (b) The ingredient must be of a pu- § 170.3(n)(20) of this rity suitable for its intended use. chapter.

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