[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.75]
[Page 341-342]
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 342]]
(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 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.
[42 FR 15643, Mar. 22, 1977, as amended at 50 FR 47534, Nov. 19, 1985;
63 FR 14817, Mar. 27, 1998]
Additives that reference this regulation: |
