21 CFR §74.2705

1. (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.
2. (b)Specifications.
   1. (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:
   2. (2)FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter.
3. (c)Uses and restrictions.
   1. (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. (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.
4. (d)Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.
5. (e)Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations in part 80 of this chapter.