Code of Federal Regulations Title 21. Food and Drugs § 21.73.1375 Pyrogallol

(a) Identity. The color additive pyrogallol is 1,2,3–trihydroxybenzene.

(b) Specifications. Pyrogallol shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:

Melting point, between 130° and 133 °C.

Residue on ignition, not more than 0.1 percent.

Lead (as Pb), not more than 20 p/m (parts per million).

Arsenic (as As), not more than 3 p/m.

(c) Uses and restrictions.Pyrogallol may be safely used in combination with ferric ammonium citrate (as listed in § 73.1025), for coloring plain and chromic catgut sutures for use in general and ophthalmic surgery, subject to the following restrictions:

(d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.