Food and Drug Administration, HHS § 73.575

(2) Lead, not more than 0.4 milli- (c) Uses and restrictions. Spirulina ex- grams per kilogram (mg/kg) (0.4 parts tract may be safely used for coloring per million (ppm)). confections (including candy and chew- (3) Arsenic, not more than 0.05 mg/kg ing gum), frostings, ice cream and fro- (0.05 ppm). zen desserts, dessert coatings and top- (4) Mercury, not more than 0.05 mg/ pings, beverage mixes and powders, yo- kg (0.05 ppm). gurts, custards, puddings, cottage (5) Cadmium, not more than 0.2 mg/ cheese, gelatin, breadcrumbs, ready-to- kg (0.2 ppm). eat cereals (excluding extruded cere- (c) Uses and restrictions. Soy als), coating formulations applied to leghemoglobin may be safely used in dietary supplement tablets and cap- ground beef analogue products such sules, at levels consistent with good that the amount of soy leghemoglobin manufacturing practice, and to season- protein does not exceed 0.8 percent by ally color the shells of hard-boiled weight of the uncooked ground beef eggs, except that it may not be used to analogue product. color foods for which standards of iden- (d) Labeling. The label of the color ad- tity have been issued under section 401 ditive and of any mixture prepared of the Federal Food, Drug, and Cos- therefrom intended solely or in part for metic Act, unless the use of the added coloring purposes must conform to color is authorized by such standards. § 70.25 of this chapter. (d) Labeling requirements. The label of (e) Exemption from certification. Cer- the color additive and of any mixture tification of this color additive is not prepared therefrom intended solely or necessary for the protection of the pub- in part for coloring purposes must con- lic health, and therefore batches there- form to § 70.25 of this chapter. of are exempt from the certification re- (e) Exemption from certification. Cer- quirements of section 721(c) of the Fed- tification of this color additive is not eral Food, Drug, and Cosmetic Act. necessary for the protection of the pub- lic health, and therefore batches there- [84 FR 37576, Aug. 1, 2019] of are exempt from the certification re- quirements of section 721(c) of the Fed- § 73.530 Spirulina extract. eral Food, Drug, and Cosmetic Act. (a) Identity. (1) The color additive spirulina extract is prepared by the fil- [78 FR 49120, Aug. 13, 2013, as amended at 79 FR 20098, May 13, 2014; 80 FR 50765, Aug. 21, tered aqueous extraction of the dried 2015; 82 FR 30734, July 3, 2017] biomass of Arthrospira platensis. The color additive contains phycocyanins § 73.575 Titanium dioxide. as the principal coloring components. (a) Identity. (1) The color additive ti- (2) Color additive mixtures for food tanium dioxide is synthetically pre- use made with spirulina extract may pared TiO2, free from admixture with contain only those diluents that are other substances. suitable and are listed in this subpart (2) Color additive mixtures for food as safe for use in color additive mix- use made with titanium dioxide may tures for coloring foods. contain only those diluents that are (b) Specifications. Spirulina extract suitable and that are listed in this sub- must conform to the following speci- part as safe in color additive mixtures fications and must be free from impuri- for coloring foods, and the following: ties, other than those named, to the ex- Silicon dioxide, SiO2 and/or aluminum tent that such other impurities may be oxide, Al2 O3, as dispersing aids—not avoided by good manufacturing prac- more than 2 percent total. tice: (b) Specifications. Titanium dioxide (1) Lead, not more than 2 milligrams shall conform to the following speci- per kilogram (mg/kg) (2 part per mil- fications: lion (ppm)); (2) Arsenic, not more than 2 mg/kg (2 Lead (as Pb), not more than 10 parts per mil- lion. ppm); Arsenic (as As), not more than 1 part per (3) Mercury, not more than 1 mg/kg (1 million. ppm); and Antimony (as Sb), not more than 2 parts per (4) Negative for microcystin toxin. million.

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Mercury (as Hg), not more than 1 part per subpart as safe and suitable for use in million. color additive mixtures for coloring ° Loss on ignition at 800 C. (after drying for 3 food. hours at 105 °C.), not more than 0.5 percent. Water soluble substances, not more than 0.3 (b) Specifications. (1) Tomato lycopene percent. extract shall conform to the following Acid soluble substances, not more than 0.5 specification: Lycopene, not less than percent. 5.5 percent of oleoresin as determined TiO2, not less than 99.0 percent after drying by the method entitled ‘‘Qualitative for 3 hours at 105 °C. Analysis of Lycopene, Its Isomers and Other Carotenoids in Different Con- Lead, arsenic, and antimony shall be ® determined in the solution obtained by centrations of Lyc-O-Mato (Tomato boiling 10 grams of the titanium diox- Oleoresin) and in Tomato Pulp by High ide for 15 minutes in 50 milliliters of Performance Liquid Chromatography 0.5N hydrochloric acid. (HPLC),’’ S.O.P. number : Lab/119/01, (c) Uses and restrictions. The color ad- Revision 01, dated May 30, 2001, pub- ditive titanium dioxide may be safely lished by LycoRed Natural Products used for coloring foods generally, sub- Industries, which is incorporated by ject to the following restrictions: reference, or an equivalent method. (1) The quantity of titanium dioxide The Director of the Office of the Fed- does not exceed 1 percent by weight of eral Register approves this incorpora- the food. tion by reference in accordance with 5 (2) It may not be used to color foods U.S.C. 552(a) and 1 CFR part 51. You for which standards of identity have may obtain a copy of the method from been promulgated under section 401 of the Center for Food Safety and Applied the act unless added color is authorized Nutrition (HFS–200), Food and Drug by such standards. Administration, 5001 Campus Dr., Col- (d) Labeling. The label of the color ad- lege Park, MD 20740. You may inspect a ditive and any mixtures intended sole- copy at theFood and Drug Administra- ly or in part for coloring purposes pre- tion’s Main Library, 10903 New Hamp- pared therefrom shall conform to the shire Ave., Bldg. 2, Third Floor, Silver requirements of § 70.25 of this chapter. Spring, MD 20993, 301–796–2039, or at the (e) Exemption from certification. Cer- National Archives and Records Admin- tification of this color additive is not istration (NARA). For information on necessary for the protection of the pub- the availability of this material at lic health and therefore batches thereof NARA, call 202–741–6030, or go to: http:// are exempt from the certification re- www.archives.gov/federallregister/ quirements of section 721(c) of the act. codeloflfederallregulations/ ibrllocations.html § 73.585 Tomato lycopene extract; to- (2) Tomato lycopene concentrate mato lycopene concentrate. shall conform to the following speci- (a) Identity. (1) The color additive to- fication: Lycopene, not less than 60 mato lycopene extract is a red to dark percent of oleoresin as determined by brown viscous oleoresin extracted with the method identified in paragraph ethyl acetate from tomato pulp fol- (b)(1) of this section. lowed by removal of the solvent by (c) Uses and restrictions. Tomato lyco- evaporation. The pulp is produced from pene extract and tomato lycopene con- fresh, edible varieties of the tomato by centrate may be safely used for color- removing the liquid. The main coloring ing foods generally in amounts con- component is lycopene. sistent with good manufacturing prac- (2) The color additive tomato lyco- tice, except that they may not be used pene concentrate is a powder prepared to color foods for which standards of from tomato lycopene extract by re- identity have been issued under section moving most of the tomato lipids with 401 of the act, unless the use of added ethyl acetate and then evaporating off color is authorized by such standards. the solvent. (d) Labeling. The label of the color ad- (3) Color additive mixtures made ditive shall conform to the require- with tomato lycopene extract or to- ments of § 70.25 of this chapter. mato lycopene concentrate may con- (e) Exemption from certification. Cer- tain only those diluents listed in this tification of this color additive is not

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