(a) Identity. The color additive D&C Black No. 4 is a high-purity carbon black prepared by the oil furnace process. It is manufactured by the combustion of aromatic petroleum oil feedstock and consists essentially of pure carbon, formed as aggregated fine particles with a surface area range of 50 to 260 meters (m)2/gram.

(b) Specifications. D&C Black No. 4 must conform to the following specifications and must be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:

(1) Surface area by nitrogen BET (Brunauer, Emmett, Teller) method, 50 to 260 m2/gram.

(2) Weight loss on heating at 950 °C for 7 minutes (predried for 1 hour at 125 °C), not more than 2 percent.

(3) Ash content, not more than 0.15 percent.

(4) Arsenic (total), not more than 3 milligrams per kilogram (mg/kg) (3 parts per million).

(5) Lead (total), not more than 10 mg/kg (10 parts per million).

(6) Mercury (total), not more than 1 mg/kg (1 part per million).

(7) Total sulfur, not more than 0.65 percent.

(8) Total polycyclic aromatic hydrocarbons (PAHs), not more than 0.5 mg/kg (500 parts per billion).

(9) Benzo[a]pyrene, not more than 0.005 mg/kg (5 parts per billion).

(10) Dibenz[a,h]anthracene, not more than 0.005 mg/kg (5 parts per billion).

(11) Total color (as carbon), not less than 95 percent.

(c) Uses and restrictions.

(1) D&C Black No. 4 may be safely used at a level not to exceed 1.0 percent by weight of the suture material for coloring ultra-high molecular weight polyethylene non-absorbable sutures for general surgical use.

(2) Authorization and compliance with this use must not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the ultra-high molecular weight polyethylene surgical sutures in which D&C Black No. 4 is used.

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

(e) Certification. All batches of D&C Black No. 4 must be certified in accordance with regulations in part 80 of this chapter.

[83 FR 26359, June 7, 2018]