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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. 537

Cytec Industries Incorporation

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'-(1,4-Phenylene)bis[4H-3,1-benzoxazin-4-one] (CAS Reg. No. 18600-59-4). REPLACES FCNs 428 and 493
Notifier: Cytec Industries Incorporation
Manufacturer/Supplier: Cytec Industries Incorporation
Intended Use: To be used as an ultraviolet (UV) light stabilizer in ethylene phthalate (PET) polymers complying with 21 CFR 177.1630 (Polyethylene phthalate polymers), 21 CFR 177.1315 (Ethylene-1,4-cyclohexylene dimethylene terephthalate copolymers), or that are the subject of an effective FCN.
Limitations/Specifications: The substance will be used at levels not to exceed 1.0 percent by weight in the polymer for single and repeat use in contact with food types I, II, III, IVA, IVB, V, VIA, VIB, VIC (containing up to 15 percent alcohol), VIIA, VIIB, VIII, IX under Conditions of Use C through G, as described in Tables 1 and 2.
Effective Date: Nov 17, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo