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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. 895

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 neopentanetetrayl bis(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 in olefin polymers (linear low density polyethylene- LLDPE) articles intended for contact with food.
Limitations/Specifications: The FCS will be used at levels not to exceed 0.05 percent by weight in olefin polymers (linear low-density polyethylene (LLDPE)) complying with 21 CFR 177.1520(c) items 3.1 and 3.2. The finished LLDPE may be used in contact with aqueous and acidic foods under Conditions of Use B through H and in contact with alcoholic and fatty foods under Conditions of Use C through G.
Effective Date: Aug 13, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo