98-16504. EM Industries, Inc.; Filing of Color Additive Petition

[Federal Register Volume 63, Number 119 (Monday, June 22, 1998)]
[Notices]
[Pages 33934-33935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16504]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98C-0431]


EM Industries, Inc.; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that EM 
Industries, Inc., has filed a petition proposing that the color 
additive regulations be amended to provide for the safe use of 
synthetic iron oxide to color ingested drugs at levels higher than the 
current limit and to provide for the safe use of mica to color ingested 
drugs.


[[Page 33935]]


FOR FURTHER INFORMATION CONTACT: Aydin Orstan, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3076.

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 8C0257) has been filed by EM Industries, 
Inc., 7 Skyline Dr., Hawthorne, NY 10532. The petition proposes to 
amend the color additive regulations to provide for the safe use of 
synthetic iron oxide to color ingested drugs at levels higher than the 
current limit and to provide for the safe use of mica to color ingested 
drugs.
    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: June 10, 1998.
Laura M. Tarantino,
Acting Director, Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 98-16504 Filed 6-19-98; 8:45 am]
BILLING CODE 4160-01-F