21 CFR § 73.32 - Antarctic krill meal.

§ 73.32 Antarctic krill meal.

(a) Identity.

(1) The color additive Antarctic krill meal consists of the cooked, dried, and ground biomass of whole Euphausia superba (Antarctic krill), with or without removal of the lipid fraction. The lipid fraction may be fully or partially extracted with ethanol, followed by removal of residual ethanol, to produce defatted Antarctic krill meal. Whole Antarctic krill meal, produced when the lipid fraction is not removed, may contain ethoxyquin as a preservative.

(2) Color additive mixtures for fish feed use made with Antarctic krill meal 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. Antarctic krill meal 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) Physical state, solid.

(2) Ethoxyquin, not more than 250 milligrams per kilogram (mg/kg) (250 parts per million (ppm)) in whole Antarctic krill meal.

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

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

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

(6) Cadmium, not more than 2 mg/kg (2 ppm).

(7) Fluoride, not more than 2,500 mg/kg (2,500 ppm).

(8) Astaxanthin, not more than 170 mg/kg (170 ppm) in whole Antarctic krill meal; not more than 90 mg/kg (90 ppm) in defatted Antarctic krill meal.

(c) Uses and restrictions. Antarctic krill meal may be safely used in salmonid feed in accordance with the following prescribed conditions:

(1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish;

(2) The color additive may be used at levels not to exceed 4 percent by weight in freshwater salmonid feed and 12 percent by weight in marine salmonid feed;

(3) The quantity of the color additive incorporated in the feed is such that the finished feed meets the tolerance limitation for ethoxyquin in animal feed prescribed in § 573.380 of this chapter; and

(4) The quantity of astaxanthin in the finished feed, from Antarctic krill meal when used alone or in combination with other astaxanthin color additive sources listed in this part, must not exceed 80 mg/kg astaxanthin (72 grams per ton) in the finished feed.

(d) Labeling requirements.

(1) The labeling of the color additive and any premixes prepared therefrom must bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by § 70.25 of this chapter, a statement of the concentration of ethoxyquin contained therein (whole Antarctic krill meal only), and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section.

(2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section must be declared in accordance with § 501.4 of this chapter.

(3) The presence of the color additive in salmonid fish that have been fed feeds containing Antarctic krill meal must be declared in accordance with §§ 101.22(b), (c), and (k)(2) and 101.100(a)(2) 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.

[87 FR 27935, May 10, 2022]