[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.35]

[Page 369-370]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 73_LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents
 
                             Subpart A_Foods
 
Sec. 73.35  Astaxanthin.

    (a) Identity. (1) The color additive astaxanthin is 3, 3'- 
dihydroxy-[beta], [beta]-carotene-4, 4'-dione.
    (2) Astaxanthin may be added to the fish feed only as a component of 
a stabilized color additive mixture. Color additive mixtures for fish 
feed use made with astaxanthin 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. Astaxanthin 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:

Physical state, solid.
0.05 percent solution in chloroform, complete and clear.
Absorption maximum wavelength 484-493 nanometers (in chloroform).
Residue on ignition, not more than 0.1 percent.
Total carotenoids other than astaxanthin, not more than 4 percent.
Lead, not more than 5 parts per million.
Arsenic, not more than 2 parts per million.
Mercury, not more than 1 part per million.
Heavy metals, not more than 10 parts per million.
Assay, minimum 96 percent.

    (c) Uses and restrictions. Astaxanthin 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 color additive in feed is such that the color 
additive shall not exceed 80 milligrams per kilogram (72 grams per ton) 
of finished feed.

[[Page 370]]

    (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 Sec. 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 Sec. 501.4 of this chapter.
    (3) The presence of the color additive in salmonid fish that have 
been fed feeds containing astaxanthin shall be declared in accordance 
with Sec. Sec. 101.22(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.

[60 FR 18738, Apr. 13, 1995]