00-21012. FEM, Inc.; Filing of Color Additive Petition

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that FEM, Inc., has filed a petition proposing that the color additive regulations be amended to eliminate the limitation on the amount of silver used as a color additive in fingernail polish.

FOR FURTHER INFORMATION CONTACT:

James C. Wallwork, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3078.

SUPPLEMENTARY INFORMATION:

Under the Federal Food, Drug, and Cosmetic Act (sec. 721(d)(1) (21 U.S.C. 379e(d)(1))), notice is given that a color additive petition (CAP 0C0272) has been filed by FEM, Inc., 1521 Laguna St. #210, Santa Barbara, CA 93101. The petition proposes to amend the color additive regulations in § 73.2500 Silver (21 CFR 73.2500) to eliminate the limitation on the amount of silver used as a color additive in fingernail polish.

The agency has determined under 21 CFR 25.32(r) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Dated: August 1, 2000.

Alan M. Rulis,

Director, Office of Premarket Approval, Center for Food Safety and Applied Nutrition.