[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.355]
[Page 354-355]
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
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 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
[[Page 355]]
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 Sec. Sec. 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]
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