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74.1340 FD&C Red No. 40.

Home > Regulations > Listing of color additives subject to certification > 74.1340 FD&C Red No. 40.






[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR74.1340]



[Page 406]

 

                        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 B_Drugs

 

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 

coloring drugs.

    (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 

manufacturing practice.

    (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 

chapter.

    (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 

chapter.



[42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 74, Section 1340


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