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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. 22

Adeka Corporation

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: Phosphorous acid, cyclic neopentanetetraylbis(2,6-di-tert-butyl-4-methylphenyl) ester (CAS Reg. No. 80693-00-1)
Notifier: Adeka Corporation
Manufacturer/Supplier: Adeka Corporation
Intended Use: As an antioxidant and/or stabilizer in high-density polyethylene homopolymer and copolymers articles intended for contact with food.
Limitations/Specifications*: The food contact substance (FCS) is to be used at levels not to exceed 0.15 percent by weight of the high-density polyethylene homopolymer and copolymers complying with 21 CFR 177.1520. The finished homopolymer and copolymers are to be used in contact with food types I, II, IV-B, VI-B, VII-B, and VIII, under Conditions of Use B through H, as described in Tables 1 and 2, and with food of types III, IV-A, V, VI-A, VI-C, VII-A, and IX, under Conditions of Use C through G, as described in Tables 1 and 2.
Effective Date: Apr 8, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)