21 CFR § 74.1208 - D&c Green No. 8.

---
identifier: "/us/cfr/t21/s74.1208"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 74.1208 - D&C Green No. 8."
title_number: 21
title_name: "Food and Drugs"
section_number: "74.1208"
section_name: "D&C Green No. 8."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "74"
part_name: "LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e."
regulatory_source: "42 FR 15654, Mar. 22, 1977, unless otherwise noted."
cfr_part: "74"
---


# 74.1208 D&C Green No. 8.

(a) *Identity.* (1) The color additive D&C Green No. 8 is principally the trisodium salt of 8-hydroxy-1,3,6-pyrene-trisulfonic acid.

(2) Color additive mixtures for use in externally applied drugs made with D&C Green No. 8 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs.

(b) *Specifications.* D&C Green No. 8 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 practices:

Volatile matter (at 135 °C), not more than 15 percent.

Water-insoluble matter, not more than 0.2 percent.

Chlorides and sulfates (calculated as sodium salt), not more than 20 percent.

The trisodium salt of 1,3,6-pyrenetrisulfonic acid, not more than 6 percent.

The tetrasodium salt of 1,3,6,8-pyrenetetrasulfonic acid, not more than 1 percent.

Pyrene, not more than 0.2 percent.

Lead (as Pb), not more than 20 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 65 percent.

(c) *Uses and restrictions.* D&C Green No. 8 may be safely used in externally applied drugs in amounts not exceeding 0.01 percent by weight of the finished product.

(d) *Labeling.* The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.

(e) *Certification.* All batches of D&C Green No. 8 shall be certified in accordance with regulations in part 80 of this chapter.