[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.10]
[Page 326-327]
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
[[Page 327]]
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]
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