Code of Federal Regulations Title 21. Food and Drugs § 21.74.2705 FD&C Yellow No. 5

(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:

Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent.

Water-insoluble matter, not more than 0.2 percent.

4,4′–[4,5–Dihydro–5–oxo–4–[ (4–sulfophenyl)hydrazono]–1H–pyrazol– 1,3–diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent.

4–[ (4′,5–Disulfo[1,1′-biphenyl]–2–yl) hydrazono]–4,5–dihydro–5–oxo–1– (4–sulfophenyl)–1H–pyrazole–3–carboxylic acid, tetrasodium salt, not more than 1 percent.

Ethyl or methyl 4,5–dihydro–5–oxo–1–(4–sulfophenyl)–4– [ (4–sulfophenyl)hydrazono]–1H–pyrazole –3–carboxylate, disodium salt, not more than 1 percent.

Sum of 4,5–dihydro–5–oxo–1–phenyl–4–[ (4–sulfophenyl)azo]–1H–pyrazole–3–carboxylic acid, disodium salt, and 4,5–dihydro–5–oxo–4–(phenylazo)–1–(4–sulfophenyl)–1H–pyrazole–3–carboxylic acid, disodium salt, not more than 0.5 percent.

4–Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent.

4,5–Dihydro–5–oxo–1–(4–sulfophenyl)–1H-pyrazole–3–carboxylic acid, disodium salt, not more than 0.2 percent.

Ethyl or methyl 4,5–dihydro–5–oxo–1–(4–sulfophenyl)–1H-pyrazole–3–carboxylate, sodium salt, not more than 0.1 percent.

4,4′–(1–Triazene–1,3–diyl)bis[benzenesulfonic acid], disodium salt, not more than 0.05 percent.

4–Aminoazobenzene, not more than 75 parts per billion.

4–Aminobiphenyl, not more than 5 parts per billion.

Aniline, not more than 100 parts per billion.

Azobenzene, not more than 40 parts per billion.

Benzidine, not more than 1 part per billion.

1,3–Diphenyltriazene, not more than 40 parts per billion.

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 3 parts per million.

Mercury (as Hg), not more than 1 part per million.

Total color, not less than 87 percent.

(2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter.

(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.