[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: 21CFR70.10]

[Page 332]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 70--COLOR ADDITIVES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 70.10  Color additives in standardized foods and new drugs.

    (a) Standardized foods. (1) Where a petition is received for 
issuance or amendment of a regulation establishing a definition and 
standard of identity for a food under section 401 of the act, which 
proposes the inclusion of a color additive in the standardized food, the 
provisions of the regulations in part 71 of this chapter shall apply 
with respect to the information that must be submitted with respect to 
the safety of the color additive (if such information has not previously 
been submitted and safety of the color additive for the intended use has 
not been already established), and the petition must show also that the 
use of the color additive in the standardized food would be in 
conformance with section 401 of the act or with the terms of a temporary 
permit issued under Sec. 130.17 of this chapter.
    (2) If a petition for a definition and standard of identity contains 
a proposal for a color additive regulation, and the petitioner fails to 
designate it as such, the Commissioner, upon determining that the 
petition includes a proposal for a color additive regulation, shall so 
notify the petitioner and shall thereafter proceed in accordance with 
the regulations in part 71 of this chapter.
    (3) A regulation will not be issued allowing the use of a color 
additive in a food for which a definition and standard of identity is 
established, unless its issuance is in conformance with section 401 of 
the act or with the terms of a temporary permit issued under Sec. 130.17 
of this chapter. When the contemplated use of such additive complies 
with the terms of a temporary permit, the color additive regulation will 
be conditioned on such compliance and will expire with the expiration of 
the temporary permit.
    (b) New drugs. (1) Where an application for a new drug is received 
and this application proposes, for coloring purposes only, the inclusion 
of a color additive, the provisions of the regulations in part 71 of 
this chapter shall apply with respect to the information that must be 
submitted about the safety of the color additive, if such information 
has not previously been submitted and safety of the color additive for 
the intended use has not already been established.
    (2) If an application for a new drug inferentially contains a 
proposal for a color additive regulation, and the applicant fails to 
designate it as such, the Commissioner, upon determining that the 
application includes a proposal for a color additive regulation, shall 
so notify the applicant and shall thereafter proceed in accordance with 
the regulations in part 71 of this chapter.
    (3) Where a petition for a color additive must be filed in 
accordance with paragraph (b)(2) of this section, the date of filing of 
the color additive petition shall be considered as the date of filing of 
the new-drug application.

[42 FR 15636, Mar. 22, 1977, as amended at 64 FR 400, Jan. 5, 1999]