[Federal Register Volume 77, Number 176 (Tuesday, September 11, 2012)]
[Rules and Regulations]
[Page 55693]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22296]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. FDA-2011-C-0050]


D&C Red No. 6 and D&C Red No. 7; Change in Specification; 
Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is confirming the 
effective date of August 7, 2012, for the final rule that published in 
the Federal Register of July 6, 2012 (77 FR 39921) and that revised the 
requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the 
current specification for ``Ether-soluble matter'' with a maximum limit 
of 0.015 percent for the recently identified impurity 1-[(4-
methylphenyl)azo]-2-naphthalenol.

DATES: Effective Date Confirmed: August 7, 2012.

FOR FURTHER INFORMATION CONTACT:  Teresa A. Croce, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1281.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 6, 2012, FDA 
amended the color additive regulations in Sec. Sec.  74.1306 and 
74.1307 (21 CFR 74.1306 and 74.1307) by replacing the current 
specification for ``Ether-soluble matter'' with a maximum limit of 
0.015 percent for the recently identified impurity 1-[(4-
methylphenyl)azo]-2-naphthalenol. FDA also removed Appendix A in 21 CFR 
part 74, which pertains to the ether-soluble matter specification. The 
changes to Sec. Sec.  74.1306 and 74.1307 also affect the color 
additive regulations in Sec. Sec.  74.2306 and 74.2307 (21 CFR 74.2306 
and 74.2307) because the identity and specifications in Sec. Sec.  
74.1306 and 74.1307 are referenced by Sec. Sec.  74.2306 and 74.2307.
    FDA gave interested persons until August 6, 2012, to file 
objections or requests for a hearing. The Agency received no objections 
or requests for a hearing on the final rule. Therefore, FDA finds that 
the effective date of the final rule that published in the Federal 
Register of July 6, 2012, should be confirmed.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, and 
redelegated to the Director, Office of Food Additive Safety, notice is 
given that no objections or requests for a hearing were filed in 
response to the July 6, 2012, final rule. Accordingly, the amendments 
issued thereby became effective August 7, 2012.

    Dated: September 5, 2012.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2012-22296 Filed 9-10-12; 8:45 am]
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