(a) Identity. (1) The color additive gardenia (genipin) blue is prepared by reacting genipin extracted from the fruit of Gardenia jasminoides Ellis with soy protein hydrolysate. The color additive contains a genipin-peptide polymer as the principal coloring component.

(2) Color additive mixtures for food use made with gardenia (genipin) blue may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods.

(b) Specifications. Gardenia (genipin) blue must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:

(1) Genipin, not more than 5 milligram per kilogram (mg/kg) (5 part per million (ppm)).

(2) Geniposide, not more than 80 mg/kg (80 ppm).

(3) Methanol, not more than 300 mg/kg (300 ppm)

(4) Lead, not more than 2 mg/kg (2 ppm).

(5) Arsenic, not more than 2 mg/kg (2 ppm).

(6) Mercury, not more than 1 mg/kg (1 ppm).

(7) Cadmium, not more than 1 mg/kg (1 ppm).

(c) Uses and restrictions. Gardenia (genipin) blue may be safely used in amounts consistent with good manufacturing practice for coloring sport drinks, flavored or enhanced noncarbonated water, fruit drinks and ades, ready-to-drink teas, hard candy, and soft candy, except that it may not be used for coloring foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of added color is authorized by such standards.

(d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes must conform to the requirements of § 70.25 of this chapter. The label of the powdered form of the additive must also declare any additional ingredients used in its manufacture.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches of the color additive are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.