[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 73_LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table
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
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
(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.
(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
(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]
Additives that reference this regulation: