21 CFR 74.2705 - FD&C Yellow No. 5.
(a) Identity. The color additive FD&C Yellow No. 5 is principally the trisodium salt of 4,5-dihydro-5-oxo-(1-4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid (CAS Reg. No. 1934-21-0). To manufacture the additive, 4-aminobenzenesulfonic acid is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is coupled with 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt.
(1) FD&C Yellow No. 5 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:
(c) Uses and restrictions.
(1) FD&C Yellow No. 5 may be safely used for coloring cosmetics generally, including cosmetics 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 cosmetics intended for use in the area of the eye, subject to the restrictions on use of color additives in § 70.5(b) and (c) of this chapter, in amounts consistent with current good manufacturing practice.
(e) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations in part 80 of this chapter.