2011-8575. Sun Chemical Corp.; Filing of Color Additive Petition

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that Sun Chemical Corp. has filed a petition proposing that the color additive regulations for D&C Red No. 6 and D&C Red No. 7 be amended 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.

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, 301-436-1281.

SUPPLEMENTARY INFORMATION:

Under the Federal Food, Drug, and Cosmetic Act (section 721(d)(1) (21 U.S.C. 379e(d)(1))), notice is given that a color additive petition (CAP 1C0290) has been filed by Sun Chemical Corp., 5020 Spring Grove Ave., Cincinnati, OH 45232. The petition proposes to amend the color additive regulations for D&C Red No. 6 (21 CFR 74.1306 and 74.2306) and D&C Red No. 7 (21 CFR 74.1307 and 74.2307) 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 and by removing Appendix A in 21 CFR part 74, which pertains to the “Ether-soluble matter” specification.

The Agency has determined under 21 CFR 25.30(i) 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: April 4, 2011.

Mitchell A. Cheeseman,

Acting Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition.