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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 532

Asahi Denka Company, Ltd.

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.
Food Contact Substance: 2,2'-methylenebis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol) (CAS Reg. No. 103597-45-1).
Notifier: Asahi Denka Company, Ltd.
Manufacturer/Supplier: Asahi Denka Company, Ltd.
Intended Use: As an ultraviolet light absorber in polycarbonate food-contact articles complying with Title 21 CFR 177.1580 Polycarbonate resins.
Limitations/Specifications: For use at levels not to exceed 2.0 percent by weight of the polycarbonate food-contact article in contact with food types: 1) I, II, IV(B), VI(up to 15 percent alcohol), VII(B), and VIII under Conditions of Use B through H, and, 2) III, IV(A), V, VI, VII(A), and X under Conditions of Use C through G, as described in Tables 1 and 2 respectively.
Effective Date: Oct 28, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo