[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: 21CFR73.75]
 
 [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. 73.75  Canthaxanthin.
 
     (a) Identity. (1) The color additive canthaxanthin is [beta]-
 carotene-4,4'-dione.
     (2) Color additive mixtures for food use made with canthaxanthin may
 contain only those diluents that are suitable and that are listed in
 this subpart as safe for use in color additive mixtures for coloring
 foods.
 
 [[Page 349]]
 
     (b) Specifications. Canthaxanthin shall conform to the following
 specifications and shall be free from impurities other than those named
 to the extent that such other impurities may be avoided by good
 manufacturing practice:
 
 Physical state, solid.
 1 percent solution in chloroform, complete and clear.
 Melting range (decomposition), 207 [deg]C. to 212 [deg]C. (corrected).
 Loss on drying, not more than 0.2 percent.
 Residue on ignition, not more than 0.2 percent.
 Total carotenoids other than trans-canthaxanthin, not more than 5
 percent.
 Lead, not more than 10 parts per million.
 Arsenic, not more than 3 parts per million.
 Mercury, not more than 1 part per million.
 Assay, 96 to 101 percent.
 
     (c) Use and restrictions. (1) The color additive canthaxanthin may
 be safely used for coloring foods generally subject to the following
 restrictions:
     (i) The quantity of canthaxanthin does not exceed 30 milligrams per
 pound of solid or semisolid food or per pint of liquid food; and
     (ii) It may not be used to color foods for which standards of
 identity have been promulgated under section 401 of the act unless added
 color is authorized by such standards.
     (2) Canthaxanthin may be safely used in broiler chicken feed to
 enhance the yellow color of broiler chicken skin in accordance with the
 following conditions: The quantity of canthaxanthin incorporated in the
 feed shall not exceed 4.41 milligrams per kilogam (4 grams per ton) of
 complete feed to supplement other known sources of xanthophyll and
 associated carotenoids to accomplish the intended effect.
     (3) Canthaxanthin may be safely used in the feed of salmonid fish in
 accordance with the following prescribed conditions:
     (i) Canthaxanthin may be added to the fish feed only in the form of
 a stabilized color additive mixture;
     (ii) The color additive is used to enhance the pink to orange-red
 color of the flesh of salmonid fish; and
     (iii) The quantity of color additive in feed 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 mixture prepared therefrom intended solely or in part for
 coloring purposes shall conform to the requirements of Sec. 70.25 of
 this chapter.
     (2) For purposes of coloring fish, the labeling of the color
 additive and any premixes prepared therefrom shall bear expiration dates
 (established through generally accepted stability testing methods) for
 the sealed and open container, 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)(3) of this
 section.
     (3) The presence of the color additive in finished fish feed
 prepared according to paragraph (c)(3) of this section shall be declared
 in accordance with Sec. 501.4 of this chapter.
     (4) The presence of the color additive in salmonid fish that have
 been fed feeds containing canthaxanthin 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.
 
 [42 FR 15643, Mar. 22, 1977, as amended at 50 FR 47534, Nov. 19, 1985;
 63 FR 14817, Mar. 27, 1998]