[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.185]

[Page 348-349]
 
                        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. 73.185  Haematococcus algae meal.

    (a) Identity. (1) The color additive haematococcus algae meal 
consists of the comminuted and dried cells of the alga Haematococcus 
pluvialis.
    (2) Haematococcus algae meal 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 haematococcus algae meal 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. Haematococcus algae meal 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.

[[Page 349]]

Heavy metals (as Pb), not more than 10 parts per million.
Astaxanthin, not less than 1.5 percent.

    (c) Uses and restrictions. Haematococcus algae meal 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 haematococcus 
algae meal 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 haematococcus algae meal 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 41584, July 6, 2000]