§ 73.30 21 CFR Ch. I (4–1–10 Edition)

there is no penetration of the color ad- Limed . ditive mixture or any of its compo- Naphtha. nents through the eggshell into the Pentaerythritol ester of fumaric acid-rosin egg: adduct. Polyethylene glycol 6000 (as identified in Alcohol, denatured, formula 23A (26 CFR § 172.820 of this chapter). part 212), Internal Revenue Service. Polyvinyl alcohol. Damar gum (). Diethylene glycol distearate. Rosin and rosin derivatives (as identified in Dioctyl sodium sulfosuccinate. § 172.615 of this chapter). Ethyl cellulose (as identified in § 172.868 of (3) Miscellaneous special uses. Items this chapter). Ethylene glycol distearate. listed in paragraph (a) of this section Japan . and the following:

Substances Definitions and specifications Restrictions

Polyvinylpyrrolidone ...... As set forth in sec. 173.55 of this chap- In or as food-tablet coatings; limit, not more ter. than 0.1 pct in the finished food; labeling of color additive mixtures containing polyvinylpyrrolidone shall bear adequate directions for use that will result in a food meeting this restriction.

[42 FR 15643, Mar. 22, 1977, as amended at 57 (b) Specifications. Annatto extract, in- FR 32175, July 21, 1992; 69 FR 24511, May 4, cluding pigments precipitated there- 2004] from, shall conform to the following specifications: § 73.30 Annatto extract. (1) Arsenic (as As), not more than 3 (a) Identity. (1) The color additive parts per million; lead as Pb, not more annatto extract is an extract prepared than 10 parts per million. from annatto seed, Bixa orellana L., (2) When solvents listed under para- using any one or an appropriate com- graph (a)(1)(ii) of this section are used, bination of the food-grade extractants annatto extract shall contain no more listed in paragraph (a)(1) (i) and (ii) of solvent residue than is permitted of the this section: corresponding solvents in (i) Alkaline aqueous solution, alka- oleoresins under applicable food addi- line propylene glycol, ethyl alcohol or tive regulations in parts 170 through alkaline solutions thereof, edible vege- 189 of this chapter. table oils or , mono- and (c) Uses and restrictions. Annatto ex- diglycerides from the glycerolysis of tract may be safely used for coloring edible vegetable oils or fats. The alka- foods generally, in amounts consistent line alcohol or aqueous extracts may with good manufacturing practice, ex- be treated with food-grade acids to pre- cept that it may not be used to color cipitate annatto pigments, which are foods for which standards of identity separated from the liquid and dried, have been promulgated under section with or without intermediate recrys- 401 of the act unless added color is au- tallization, using the solvents listed thorized by such standards. under paragraph (a)(1)(ii) of this sec- (d) Labeling. The label of the color ad- tion. Food-grade alkalis or carbonates ditive and any mixtures prepared may be added to adjust alkalinity. therefrom and intended solely or in (ii) Acetone, ethylene dichloride, part for coloring purposes shall con- hexane, isopropyl alcohol, methyl alco- form to the requirements of § 70.25 of hol, methylene chloride, trichloro- this chapter. Labels shall bear informa- ethylene. tion showing that the color is derived (2) Color additive mixtures for food from annatto seed. The requirements of use made with annatto extract may § 70.25(a) of this chapter that all ingre- contain only diluents that are suitable dients shall be listed by name shall not and that are listed in this subpart as be construed as requiring the declara- safe in color additive mixtures for tion of residues of solvents listed in coloring foods. paragraph (a)(1)(ii) of this section.

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(e) Exemption from certification. Cer- by § 70.25 of this chapter, and adequate tification of this color additive is not directions to prepare a final product necessary for the protection of the pub- complying with the limitations pre- lic health and therefore batches thereof scribed in paragraph (c) of this section. are exempt from the certification re- (2) The presence of the color additive quirements of section 721(c) of the act. in finished fish feed prepared according to paragraph (c) of this section shall be § 73.35 Astaxanthin. declared in accordance with § 501.4 of (a) Identity. (1) The color additive this chapter. astaxanthin is 3, 3′-dihydroxy-b, b-caro- (3) The presence of the color additive tene-4, 4′-dione. in salmonid fish that have been fed (2) Astaxanthin may be added to the feeds containing astaxanthin shall be fish feed only as a component of a sta- declared in accordance with bilized color additive mixture. Color §§ 101.22(k)(2) and 101.100(a)(2) of this additive mixtures for fish feed use chapter. made with astaxanthin may contain (e) Exemption from certification. Cer- only those diluents that are suitable tification of this color additive is not and are listed in this subpart as safe necessary for the protection of the pub- for use in color additive mixtures for lic health, and therefore batches there- coloring foods. of are exempt from the certification re- (b) Specifications. Astaxanthin shall quirements of section 721(c) of the act. conform to the following specifications [60 FR 18738, Apr. 13, 1995] and shall be free from impurities other than those named to the extent that § 73.37 Astaxanthin dimethyl- such impurities may be avoided by disuccinate. good manufacturing practice: (a) Identity. (1) The color additive Physical state, solid. astaxanthin dimethyldisuccinate is 0.05 percent solution in chloroform, complete 3,3′-bis(4-methoxy-1,4-dioxobutoxy)-b,b- and clear. carotene–4,4′-dione. Absorption maximum wavelength 484–493 (2) Astaxanthin dimethyldisuccinate nanometers (in chloroform). may be added to the fish feed only as a Residue on ignition, not more than 0.1 per- component of a stabilized mixture. cent. Total carotenoids other than astaxanthin, Color additive mixtures for fish feed not more than 4 percent. use made with astaxanthin Lead, not more than 5 parts per million. dimethyldisuccinate may contain only Arsenic, not more than 2 parts per million. those diluents that are suitable and are Mercury, not more than 1 part per million. listed in this subpart as safe for use in Heavy metals, not more than 10 parts per color additive mixtures for coloring million. foods. Assay, minimum 96 percent. (b) Specifications. Astaxanthin (c) Uses and restrictions. Astaxanthin dimethyldisuccinate shall conform to may be safely used in the feed of the following specifications and shall salmonid fish in accordance with the be free from impurities other than following prescribed conditions: those named to the extent that such (1) The color additive is used to en- impurities may be avoided by good hance the pink to orange-red color of manufacturing practice: the flesh of salmonid fish. (1) Physical state, solid. (2) The quantity of color additive in (2) 0.05 percent solution in chloro- feed is such that the color additive form, complete and clear. shall not exceed 80 milligrams per kilo- (3) Absorption maximum wavelength gram (72 grams per ton) of finished 484–493 nanometers (in chloroform). feed. (4) Residue on ignition, not more (d) Labeling requirements. (1) The la- than 0.1 percent. beling of the color additive and any (5) Total carotenoids other than premixes prepared therefrom shall bear astaxanthin dimethyldisuccinate, not expiration dates for the sealed and more than 4 percent. open container (established through (6) Lead, not more than 5 milligrams generally accepted stability testing per kilogram (mg/kg) (5 parts per mil- methods), other information required lion).

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