[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: 21CFR73.295]

[Page 356-357]
 
                        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. 73.295  Tagetes (Aztec marigold) meal and extract.

    (a) Identity. (1) The color additive tagetes (Aztec marigold) meal 
is the dried, ground flower petals of the Aztec marigold (Tagetes erecta 
L.) mixed with not more than 0.3 percent ethoxyquin.
    (2) The color additive tagetes (Aztec marigold) extract is a hexane 
extract of the flower petals of the Aztec marigold (Tagetes erecta L.). 
It is mixed with an edible vegetable oil, or with an edible vegetable 
oil and a hydrogenated edible vegetable oil, and not more than 0.3 
percent ethoxyquin. It may also be mixed with soy flour or corn meal as 
a carrier.
    (b) Specifications. (1) Tagetes (Aztec marigold) meal is free from 
admixture with other plant material from Tageteserecta L. or from plant 
material or flowers of any other species of plants.
    (2) Tagetes (Aztec marigold) extract shall be prepared from tagetes 
(Aztec marigold) petals meeting the specifications set forth in 
paragraph (b)(1) of this section and shall conform to the following 
additional specifications:

Melting point.............................  53.5-55.0 [deg]C.
Iodine value..............................  132-145.
Saponification value......................  175-200.
Acid value................................  0.60-1.20.
Titer.....................................  35.5[deg]-37.0 [deg]C.
Unsaponifiable matter.....................  23.0 percent-27.0 percent.
Hexane residue............................  Not more than 25 p.p.m.



All determinations, except the hexane residue, shall be made on the 
initial extract of the flower petals (after drying in a vacuum oven at 
60 [deg]C. for 24 hours) prior to the addition of the oils and 
ethoxyquin. The hexane determination

[[Page 357]]

shall be made on the color additive after the addition of the vegetable 
oils, hydrogenated vegetable oils, and ethoxyquin.
    (c) Uses and restrictions. The color additives tagetes (Aztec 
marigold) meal and extract may be safely used in chicken feed in 
accordance with the following prescribed conditions:
    (1) The color additives are used to enhance the yellow color of 
chicken skin and eggs.
    (2) The quantity of the color additives incorporated in the feed is 
such that the finished feed:
    (i) Is supplemented sufficiently with xanthophyll and associated 
carotenoids so as to accomplish the intended effect described in 
paragraph (c)(1) of this section; and
    (ii) Meets the tolerance limitation for ethoxyquin in animal feed 
prescribed in Sec. 573.380 of this chapter.
    (d) Labeling requirements. The label of the color additives and any 
premixes prepared therefrom shall bear, in addition to the information 
required by Sec. 70.25 of this chapter:
    (1) A statement of the concentrations of xanthophyll and ethoxyquin 
contained therein.
    (2) Adequate directions to provide a final product complying with 
the limitations prescribed in paragraph (c) of this section.
    (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.