Document ID: FDA-2014-C-1552-0001
Agency: fda
Document Type: Proposed Rule
Title: Colorcon, Inc.; Filing of Color Additive Petition
Posted Date: 2014-10-22T04:00Z

[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Proposed Rules]
[Page 63062]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25089]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2014-C-1552]

Colorcon, Inc.; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by Colorcon, Inc., proposing 
that the color additive regulations be amended to provide for the safe 
use of spirulina extract as a color additive in coating formulations 
applied to dietary supplement and drug tablets and capsules.

DATES: The color additive petition was filed on September 22, 2014.

FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1075.

SUPPLEMENTARY INFORMATION: Under section 721(d)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice 
that we have filed a color additive petition (CAP 4C0300), submitted by 
Colorcon, Inc., 275 Ruth Rd., Harleysville, PA 19438. The petition 
proposes to amend the color additive regulations in 21 CFR part 73 
Listing of Color Additives Exempt From Certification to provide for the 
safe use of spirulina extract as a color additive in coating 
formulations applied to dietary supplement and drug tablets and 
capsules.
    We have 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: October 16, 2014.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2014-25089 Filed 10-21-14; 8:45 am]
BILLING CODE 4164-01-P