Food and Drug Administration, HHS § 184.1950

(1) The ingredient is used in food as a (d) Prior sanctions for this ingredient supplement as defined in different from the uses established in § 170.3(o)(20) of this chapter. this section do not exist or have been (2) The ingredient is used in foods at waived. levels not to exceed current good man- [50 FR 6341, Feb. 15, 1985] ufacturing practice. A may be used in in accordance § 184.1950 Vitamin D. with section 412(g) of the Federal Food, (a) Vitamin D is added to food as the Drug, and Cosmetic Act (the act) or following food ingredients: with regulations promulgated under (1) Crystalline vitamin D2 (C28H44O, section 412(a)(2) of the Act. CAS Reg. No. 50–14–6), also known as (d) Prior sanctions for this ingredient ergocalciferol, is the chemical 9,10- different from the uses established in seco(5Z,7E,22E)-5,7,10(19),22- this section do not exist or have been ergostatetraen-3-ol. The ingredient is waived. produced by ultraviolet irradiation of [48 FR 51610, Nov. 10, 1983] ergosterol isolated from yeast and re- lated fungi and is purified by crys-

§ 184.1945 Vitamin B12. tallization. (2) Crystalline vitamin D (C H O, (a) Vitamin B , also known as cyano- 3 27 44 12 CAS Reg. No. 67–97–0), also known as cobalamin (C H CoN O P, CAS Reg. 63 88 14 14 cholecalciferol, is the chemical 9,10- No. 68–0919–099), is produced commer- seco(5Z,7E,)-5,7,10(19)-cholestatrien-3- cially from cultures of Streptomyces ol. Vitamin D3 occurs in, and is iso- griseus. lated from, fish liver oils. It is also (b) The ingredient meets the speci- manufactured by ultraviolet irradia- fications of the Food Chemicals Codex, tion of 7-dehydrocholesterol produced 3d Ed. (1981), p. 343, which is incor- from cholesterol. It is purified by crys- porated by reference. Copies are avail- tallization. Vitamin D3 is the vitamin able from the National Academy Press, D form that is produced endogenously 2101 Constitution Ave. NW., Wash- in humans through sunlight activation ington, DC 20418, or available for in- of 7-dehydrocholesterol in the skin. spection at the National Archives and (3) Vitamin D2 resin and vitamin D3 Records Administration (NARA). For resin are the concentrated forms of ir- information on the availability of this radiated ergosterol (D2) and irradiated material at NARA, call 202–741–6030, or 7-dehydrocholesterol (D3) that are sepa- go to: http://www.archives.gov/ rated from the reacting materials in federallregister/ paragraphs (a) (1) and (2) of this sec- codeloflfederallregulations/ tion. The resulting products are sold as ibrllocations.html. food sources of vitamin D without fur- (c) In accordance with § 184.1(b)(1), ther purification. the ingredient is used in food with no (b) Vitamin D2 and vitamin D3 as limitation other than current good crystals meet the specifications of the manufacturing practice. The affirma- Food Chemicals Codex, 3d Ed. (1981), tion of this ingredient as generally rec- pp. 344 and 345, which is incorporated ognized as safe (GRAS) as a direct by reference. Copies are available from human food ingredient is based upon the National Academy Press, 2101 Con- the following current good manufac- stitution Ave. NW., Washington, DC turing practice conditions of use: 20418, or available for inspection at the (1) The ingredient is used as a nutri- National Archives and Records Admin- ent supplement as defined in istration (NARA). For information on § 170.3(o)(20) of this chapter. the availability of this material at (2) The ingredient is used in food at NARA, call 202–741–6030, or go to: http:// levels not to exceed current good man- www.archives.gov/federallregister/ ufacturing practice. Vitamin B12 also codeloflfederallregulationsll may be used in infant formula in ac- ibrllocations.html. Vitamin D2 resin cordance with section 412(g) of the Fed- and vitamin D3 resin must be of a pu- eral Food, Drug, and Cosmetic Act (the rity suitable for their intended use. act) or with regulations promulgated (c)(1) In accordance with § 184.1(b)(2), under section 412(a)(2) of the act. the ingredients are used in food as the

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sole source of added vitamin D only information on the availability of this within the following specific limita- material at NARA, call 202–741–6030, or tions: go to: http://www.archives.gov/ federallregister/ Maximum levels in Category of food food (as served) Functional use codeloflfederallregulations/ ibrllocations.html. Breakfast cereals, 350 (IU/100 Nutrient supple- § 170.3(n)(4) of grams). ment, (c) The ingredient is used as a fla- this chapter. § 170.3(o)(20) of voring agent and adjuvant as defined in this chapter. § 170.3(o)(12) of this chapter, as a lubri- Grain products and 90(IU/100 grams) Do. cant as defined in § 170.3(o)(18) of this pastas, § 170.3(n)(23) of chapter, and as a surface-finishing this chapter. agent as defined in § 170.3(o)(30) of this Milk, § 170.3(n)(30) 42 (IU/100 grams) Do. chapter. of this chapter. Milk products, 89 (IU/100 grams) Do. (d) The ingredient is used in food, in § 170.3(n)(31) of accordance with § 184.1(b)(1) of this this chapter. chapter, at levels not to exceed good manufacturing practice. Current good (2) Vitamin D may be used in infant manufacturing practice results in a formula in accordance with section maximum level, as served, of: 0.065 per- 412(g) of the Federal Food, Drug, and cent for chewing gum as defined in Cosmetic Act (the act) or with regula- § 170.3(n)(6) of this chapter; 0.005 per- tions promulgated under section cent for confections and frostings as 412(a)(2) of the act. (3) Vitamin D may be used in mar- defined in § 170.3(n)(9) of this chapter; garine in accordance with § 166.110 of 0.04 percent for hard candy as defined this chapter. in § 170.3(n)(25) of this chapter; 0.1 per- (d) Prior sanctions for these ingredi- cent for soft candy as defined in ents different from the uses established § 170.3(n)(38) of this chapter; and 0.002 in this section do not exist or have percent or less for all other food cat- been waived. egories. [50 FR 30152, July 24, 1985, as amended at 73 [43 FR 14644, Apr. 7, 1978, as amended at 49 FR 8608, Feb. 14, 2008] FR 5613, Feb. 14, 1984; 50 FR 49536, Dec. 3, 1985] § 184.1973 Beeswax (yellow and white). § 184.1976 Candelilla wax. (a) Beeswax (CAS Reg. No. 8012–89–3) is a secretory product of honey bees (a) Candelilla wax (CAS Reg. No. used as a structural material in honey- 8006–44–8) is obtained from the can- combs. Beeswax is prepared from hon- delilla plant. It is a hard, yellowish- eycombs after removal of the honey by brown, opaque-to-translucent wax. draining or centrifuging. The combs Candelilla wax is prepared by immers- are melted in hot water or steam or ing the plants in boiling water con- with solar heat, and strained. The wax taining sulfuric acid and skimming off is refined by melting in hot water to the wax that rises to the surface. It is which sulfuric acid or alkali may be composed of about 50 percent hydro- added to extract impurities. The re- carbons with smaller amounts of esters sulting wax is referred to as yellow and free acids. beeswax. White beeswax is produced by (b) The ingredient meets the speci- bleaching the constituent pigments of fications of the Food Chemicals Codex, yellow beeswax with peroxides, or pref- 3d Ed. (1981), p. 67, which is incor- erably it is bleached by sun light. porated by reference. Copies are avail- (b) The ingredient meets the speci- able from the National Academy Press, fications of the ‘‘Food Chemicals 2101 Constitution Ave. NW., Wash- Codex,’’ 3d Ed. (1981), pp. 34–35, which is ington, DC 20418, or available for in- incorporated by reference. Copies may spection at the National Archives and be obtained from the National Acad- Records Administration (NARA). For emy Press, 2101 Constitution Ave. NW., information on the availability of this Washington, DC 20418, or may be exam- material at NARA, call 202–741–6030, or ined at the National Archives and go to: http://www.archives.gov/ Records Administration (NARA). For federallregister/

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