[Code of Federal Regulations]
 [Title 21, Volume 1]
 [Revised as of April 1, 2002]
 From the U.S. Government Printing Office via GPO Access
 [CITE: 21CFR73.185]
 
 [Page 354]
 
                         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.
 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]