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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. 502

BASF AG / BASF 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: Hexanedioic acid, polymer with hexahydro-2H-azepin-2-one and 1,6-hexanediamine (CAS Reg. No. 24993-04-2).
Notifier: BASF Corporation
Manufacturer/Supplier: BASF AG / BASF Corporation
Intended Use: As a component of films used in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2, respectively.
Limitations/Specifications: The films will have a maximum thickness of 1 mil (0.001 inch) of the FCS. Maximum extractable fraction in solvent (expressed in percent by weight of resin) are as follows: water (0.8); 95 percent ethyl alcohol (1.0); ethyl acetate (0.5); benzene (0.5). Adjuvant substances permitted for use in Nylon 6/66 polymers may be used in the subject copolymer subject to any limitations regarding conditions of use, food types, or any other limitation in the authorizing regulation or notification.
Effective Date: Jul 5, 2005
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 351 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement