[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR71.20]

[Page 341]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 71--COLOR ADDITIVE PETITIONS--Table of Contents
 
              Subpart B--Administrative Action on Petitions
 
Sec. 71.20  Publication of regulation.


    The Commissioner will forward for publication in the Federal 
Register, within 90 days after filing of the petition (or within 180 
days if the time is extended as provided for in section 721(d)(1) of the 
act):
    (a) A regulation listing in part 73 or 74 of this chapter the color 
additive on the appropriate list or lists as provided under section 
721(b)(1).
    (1) Such a regulation may list the color additive for use generally 
in or on foods, drugs, or cosmetics or for use in coloring the human 
body, as the case may be, or may prescribe the conditions under which 
the color additive may be safely used (including, but not limited to, 
specifications as to the particular food, drug, or cosmetic or classes 
of food, drugs, or cosmetics in or on which such color additive may be 
used, or for the material intended for coloring the human body; the 
maximum quantity of any straight color or diluent that may be used or 
permitted to remain in or on such food, drug, or cosmetic or article 
intended for coloring the human body; the manner in which such color 
additive may be added to or used in or on such food, drug, or cosmetic 
or for coloring the human body; and any directions or other labeling or 
packing requirements for such color additives deemed necessary to assure 
the safety of such use).
    (2) Such regulations shall list the color additive only for the use 
or uses for which it has been found suitable and for which it may safely 
be employed. Alternatively, the Commissioner shall by order deny the 
petition, and notify the petitioner of such order and the reasons 
therefor.
    (3) The regulation shall list any use or uses in meat, meat food 
product, or poultry product subject to the Federal Meat Inspection Act 
(FMIA) (21 U.S.C. 601 et seq.) or the Poultry Products Inspection (PPIA) 
(21 U.S.C. 451 et seq.) for which the color additive has been found 
suitable and for which it may safely be employed.
    (b) Whenever the Commissioner finds that batch certification is not 
necessary for the protection of the public health he will, by order, 
exempt the color additive from the certification procedure. In 
determining whether certification of a color additive is necessary, the 
Commissioner will consider the composition of the additive, its 
manufacturing process, possible impurities, its toxic potential, control 
and analytical procedures necessary to assure compliance with the 
listing specifications, and the variability of its composition.

[42 FR 15639, Mar. 22, 1977, as amended at 65 FR 51762, Aug. 25, 2000]