[Federal Register Volume 64, Number 118 (Monday, June 21, 1999)]
[Notices]
[Page 33097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15661]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98C-0790]


EM Industries, Inc.; Filing of Color Additive Petition; Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is amending the filing 
notice for a color additive petition filed by EM Industries, Inc., to 
clarify that the petitioner's request is to amend the color additive 
regulations to provide for the safe use of composite pigments made from 
synthetic iron oxide, titanium dioxide, and mica to color food.

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: In a notice published in the Federal 
Register of September 25, 1998 (63 FR 51359), FDA announced that a 
color additive petition (CAP 8C0262) had been filed by EM Industries, 
Inc., 7 Skyline Dr., Hawthorne, NY 10532. The petition proposed to 
amend the color additive regulations to provide for the safe use of 
synthetic iron oxide and mica to color food and to provide for the safe 
use of titanium dioxide to color food at levels higher than the current 
limit.
    The data in the petition indicated that the petitioner manufactured 
color additives, to color food, by combining synthetic iron oxide, 
mica, and titanium dioxide. Based on these data, at the time of the 
filing of the petition, FDA considered the color additive combinations 
the petitioner prepared from synthetic iron oxide, mica, and titanium 
dioxide to be color additive mixtures.
    To more accurately describe the pigments that are the subjects of 
this petition, FDA is amending the filing notice of September 25, 1998, 
to indicate that the petition proposes to amend the color additive 
regulations to provide for the safe use of composite pigments prepared 
from synthetic iron oxide, mica, and titanium dioxide to color food.
    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 2, 1999.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 99-15661 Filed 6-18-99; 8:45 am]
BILLING CODE 4160-01-F