§ 184.1973 21 CFR Ch. I (4–1–09 Edition)

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 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 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 (yellow and white). § 184.1976 Candelilla . (a) Beeswax (CAS Reg. No. 8012–89–3) is a secretory product of bees (a) (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 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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codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (c) In accordance with § 184.1(b)(1), (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no the ingredient is used in food with no limitation other than current good limitation other than current good manufacturing practice. The affirma- manufacturing practice. The affirma- tion of this ingredient as generally rec- tion of this ingredient as generally rec- ognized as safe (GRAS) as a direct ognized as safe (GRAS) as a direct human food ingredient is based upon human food ingredient is based upon the following current good manufac- the following current good manufac- turing practice conditions of use: turing practice conditions of use: (1) The ingredient is used as a lubri- (1) The ingredient is used as an cant as defined in § 170.3(o)(18) of this as defined § 170.3(o)(1) chapter and as a surface-finishing of this chapter; as a formulation aid as agent as defined in § 170.3(o)(30) of this defined in § 170.3(o)(14) of this chapter; chapter. as a lubricant and release agent as de- (2) The ingredient is used in the fol- fined in § 170.3(o)(18) of this chapter; lowing foods at levels not to exceed and as a surface-finishing agent as de- current good manufacturing practice: fined in § 170.3(o)(30) of this chapter. in chewing gum as defined in (2) The ingredient is used in the fol- § 170.3(n)(6) of this chapter and in hard lowing foods at levels not to exceed candy as defined in § 170.3(n)(25) of this current good manufacturing practice: baked goods and baking mixes as de- chapter. fined in § 170.3(n)(1) of this chapter; (d) Prior sanctions for this ingredient chewing gun as defined in § 170.3(n)(6) of different from the uses established in this chapter; confections and frostings this section do not exist or have been as defined in § 170.3(n)(9) of this chap- waived. ter; fresh fruits and fruit juices as de- [48 FR 51617, Nov. 10, 1983] fined in § 170.3(n)(16) of this chapter; gravies and sauces as defined in § 184.1978 Carnauba wax. § 170.3(n)(24) of this chapter; processed (a) Carnauba wax (CAS Reg. No. 008– fruits and fruit juices as defined in 015–869) is obtained from the leaves and § 170.3(n)(35) of this chapter; and soft buds of the Brazilian wax palm candy as defined in § 170.3(n)(38) of this Copernicia cerifera Martius. The wax is chapter. hard, brittle, sparingly soluble in cold (d) Prior sanctions for this ingredient organic solvents and insoluble in different from the uses established in water. It is marketed in five grades this section do not exist or have been designated No. 1 through No. 5. Grades waived. No. 4 and No. 5 represent the bulk of [48 FR 51147, Nov. 7, 1983] the commercial trade volume. These commercial grades consist chiefly of § 184.1979 Whey. C24 to C32 normal saturated (a)(1) Whey. Whey is the liquid sub- monofunctional fatty acids and normal stance obtained by separating the co- saturated monofunctional primary al- agulum from milk, cream, or skim cohols. milk in cheesemaking. Whey obtained (b) The ingredient meets the speci- from a procedure, in which a signifi- fications of the Food Chemicals Codex, cant amount of lactose is converted to 3d Ed. (1981), p. 73, which is incor- lactic acid, or from the curd formation porated by reference. Copies are avail- by direct acidification of milk, is able from the National Academy Press, known as acid whey. Whey obtained 2101 Constitution Ave. NW., Wash- from a procedure in which there is in- ington, DC 20418, or available for in- significant conversion of lactose to lac- spection at the National Archives and tic acid is known as sweet whey. Sweet Records Administration (NARA). For whey has a maximum titratable acid- information on the availability of this ity of not more than 0.16 percent, cal- material at NARA, call 202–741–6030, or culated as lactic acid, and an alka- go to: http://www.archives.gov/ linity of ash of not more than 225 milli- federallregister/ liters of 0.1N hydrochloric acid per 100

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