21 CFR § 73.352 - Paracoccus pigment.

§ 73.352 Paracoccus pigment.

(a) Identity.

(1) The color additive paracoccus pigment consists of the heat-killed, dried cells of a nonpathogenic and nontoxicogenic strain of the bacterium Paracoccus carotinifaciens and may contain added calcium carbonate to adjust the astaxanthin level.

(2) Color additive mixtures for fish feed use made with paracoccus pigment 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. Paracoccus pigment shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such impurities may be avoided by good manufacturing practice:

(1) Physical state, solid.

(2) Lead, not more than 5 milligrams per kilogram (mg/kg) (5 parts per million (ppm)).

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

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

(5) Heavy metals (as Pb), not more than 10 mg/kg (10 ppm).

(6) Astaxanthin, not less than 1.75 percent.

(c) Uses and restrictions. Paracoccus pigment may be safely used in the feed of salmonid fish 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 quantity of astaxanthin in finished feed, from paracoccus pigment when used alone or in combination with other astaxanthin color additive sources listed in this part 73, shall not exceed 80 mg/kg (72 grams per ton) of finished feed.

(d) Labeling requirements.

(1) The labeling of the color additive and any premixes prepared therefrom shall 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, 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 shall 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 paracoccus pigment shall 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 act.

[74 FR 58845, Nov. 16, 2009]