[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 74_LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of
Sec. 74.1340 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).
(2) Color additive mixtures for drug use made with FD&C Red No. 40
may contain only those diluents that are suitable and that are listed in
part 73 of this chapter as safe for use in color additive mixtures for
(3) The listing of this color additive includes lakes prepared as
described in Sec. Sec. 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. Sec.
82.51 or 82.1051 of this chapter.)
(b) Uses and restrictions. (1) FD&C Red No. 40 and FD&C Red No. 40
Aluminum Lake may be safely used in coloring drugs, including those
intended for use in the area of the eye, subject to the restrictions on
the use of color additives in Sec. 70.5(b) and (c) of this chapter, in
amounts consistent with current good manufacturing practice.
(2) Other lakes of FD&C Red No. 40 may be safely used in coloring
drugs, subject to the restrictions on the use of color additives in
Sec. 70.5 of this chapter, in amounts consistent with current good
(c) Labeling. The label of the color additive and any lakes or
mixtures prepared therefrom intended solely or in part for coloring
purposes shall conform to the requirements of Sec. 70.25 of this
(d) Certification. All batches of FD&C Red No. 40 and lakes thereof
shall be certified in accordance with regulations, in part 80 of this
[42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994]
Additives that reference this regulation: