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73.35 Astaxanthin.

Home > Regulations > Listing of color additives exempt from certification > 73.35 Astaxanthin.






[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: 21CFR73.35]



[Page 340-341]

 

                        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.  73.35  Astaxanthin.



    (a) Identity. (1) The color additive astaxanthin is 3, 3'-dihydroxy-

[beta], [beta]-carotene-4, 4'-dione.

    (2) Astaxanthin 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 astaxanthin 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. Astaxanthin 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.

0.05 percent solution in chloroform, complete and clear.

Absorption maximum wavelength 484-493 nanometers (in chloroform).

Residue on ignition, not more than 0.1 percent.

Total carotenoids other than astaxanthin, not more than 4 percent.

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, not more than 10 parts per million.

Assay, minimum 96 percent.



    (c) Uses and restrictions. Astaxanthin 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 color additive in feed is such that the color 

additive 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



[[Page 341]]



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 astaxanthin shall be declared in accordance 

with Sec. Sec.  101.22(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.



[60 FR 18738, Apr. 13, 1995]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 73, Section 35


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