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73.75 Canthaxanthin.

Home > Regulations > Listing of color additives exempt from certification > 73.75 Canthaxanthin.






[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:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 73, Section 75


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