(a) Identity. (1) The color additive galdieria extract blue is a liquid or powder prepared by the filtered aqueous extraction of the dried biomass of a non-pathogenic and non-toxigenic strain of Galdieria sulphuraria. The biomass is prepared by heterotrophic fermentation of G. sulphuraria. The color additive contains C-phycocyanin as the principal coloring component.

(2) Color additive mixtures for food use made with galdieria extract 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. Galdieria extract 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) Lead, not more than 0.5 milligram/kilogram (mg/kg) (0.5 parts per million (ppm)).

(2) Arsenic, not more than 0.5 mg/kg (0.5 ppm).

(3) Mercury, not more than 0.05 mg/kg (0.05 ppm).

(4) Cadmium, not more than 0.5 mg/kg (0.5 ppm).

(c) Uses and restrictions. Galdieria extract blue may be safely used for coloring non-alcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives), at levels consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of the added color is authorized by such standards.

(d) Labeling. The label of the color additive and of any mixture prepared therefrom intended solely or in part for coloring purposes must conform to the requirements of § 70.25 of this chapter.

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