[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: 21CFR74.2340]
 
[Page 420]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                SERVICES
 
PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents
 
                          Subpart C--Cosmetics
 
Sec. 74.2340  FD&C Red No. 40.
 
    (a) Identity and specifications. (1) The color additive FD&C Red No.
40 shall conform in identity and specifications to the requirements of
Sec. 74.340(a)(1) and (b) of this chapter.
    (2) The listing of this color additive includes lakes prepared as
described in Secs. 82.51 and 82.1051 of this chapter, except that the
color additive used is FD&C Red No. 40 and the resultant lakes meet the
specification and labeling requirements prescribed by Sec. 82.51 or
Sec. 82.1051 of this chapter.
    (b) Uses and restrictions. FD&C Red No. 40 may be safely used in
coloring cosmetics generally, except that only FD&C Red No. 40 and FD&C
Red No. 40 Aluminum Lake may be safely used in coloring cosmetics
intended for use in the area of the eye. These uses are subject to the
following restrictions:
    (1) The color additive may be used in amounts consistent with
current good manufacturing practice.
    (2) The color additive shall not be exposed to oxidizing or reducing
agents that may affect the integrity of the color additives or any other
condition that may affect their integrity.
    (c) Labeling. The label of the color additive shall conform to the
requirements of Sec. 70.25 of this chapter.
    (d) Certification. All batches of FD&C Red No. 40 shall be certified
in accordance with regulations in part 80 of this chapter.
 
[42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994]