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74.1705 FD&C Yellow No. 5.

Home > Regulations > Listing of color additives subject to certification > 74.1705 FD&C Yellow No. 5.






[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: 21CFR74.1705]



[Page 407-408]

 

                        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.  74.1705  FD&C Yellow No. 5.



    (a) Identity and specifications. (1) The color additive FD&C Yellow 

No. 5 shall conform in identity and specifications to the requirements 

of Sec.  74.705 (a)(1) and (b).

    (2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance 

with the requirements of Sec.  82.51 of this chapter.

    (3) Color additive mixtures for drug use made with FD&C Yellow No. 5 

may contain only those diluents that are suitable and are listed in part 

73 of this chapter as safe for use in color additive mixtures for 

coloring drugs.

    (b) Uses and restrictions. (1) FD&C Yellow No. 5 may be safely used 

for coloring drugs generally, including drugs intended for use in the 

area of the eye, in amounts consistent with current good manufacturing 

practice.

    (2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring 

drugs intended for use in the area of the eye, when prepared in 

accordance with Sec.  82.51 of this chapter.

    (c) Labeling requirements. (1) The label of the color additive and 

any mixtures intended solely or in part for coloring purposes prepared 

therefrom shall conform to the requirements of Sec.  70.25 of this 

chapter.

    (2) The label of OTC and prescription drug products intended for 

human use administered orally, nasally, rectally, or vaginally, or for 

use in the area of the eye, containing FD&C Yellow No. 5 shall 

specifically declare the presence of FD&C Yellow No. 5 by listing the 

color additive using the names FD&C Yellow No. 5 and tartrazine. The 

label shall bear a statement such as ``Contains FD&C Yellow No. 5 

(tartrazine) as a color additive'' or ``Contains color additives 

including FD&C Yellow No. 5 (tartrazine).'' The labels of certain drug 

products subject to this labeling requirement that are also cosmetics, 

such as: antibacterial mouthwashes and fluoride toothpastes, need not 

comply with this requirement provided they comply with the requirements 

of Sec.  701.3 of this chapter.

    (3) For prescription drugs for human use containing FD&C Yellow No. 

5 that are administered orally, nasally, vaginally, or rectally, or for 

use in the area of the eye, the labeling required by Sec.  201.100(d) of 

this chapter shall, in addition to the label statement required under 

paragraph (c)(2) of this section, bear the warning statement ``This 

product contains FD&C Yellow No. 5 (tartrazine) which may cause 

allergic-type reactions (including bronchial asthma) in certain 

susceptible persons. Although the overall incidence of FD&C Yellow No. 5 

(tartrazine) sensitivity in the general population is low, it is 

frequently seen in patients who also have aspirin hypersensitivity.'' 

This warning statement



[[Page 408]]



shall appear in the ``Precautions'' section of the labeling.

    (d) Certification. All batches of FD&C Yellow No. 5 shall be 

certified in accordance with regulations in part 80 of this chapter.



[42 FR 15654, Mar. 22, 1977, as amended at 44 FR 37220, June 26, 1979; 

50 FR 35782, Sept. 4, 1985; 51 FR 24519, July 7, 1986; 59 FR 60897, Nov. 

29, 1994]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 74, Section 1705


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