[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.355]

[Page 358-359]
 
                        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. 73.355  Phaffia yeast.

    (a) Identity. (1) The color additive phaffia yeast consists of the 
killed, dried cells of a nonpathogenic and nontoxicogenic strain of the 
yeast Phaffia rhodozyma.
    (2) Phaffia yeast 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 phaffia yeast 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. Phaffia yeast 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.
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 (as Pb), not more than 10 parts per million.
Astaxanthin, not less than 0.4 percent.

    (c) Uses and restrictions. Phaffia yeast may be safely used in the 
feed of

[[Page 359]]

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 phaffia yeast 
when used alone or in combination with other astaxanthin color additive 
sources listed in this part 73, 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 
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 phaffia yeast shall be declared in accordance 
with Secs. 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.

[65 FR 41587, July 6, 2000]