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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. 1223

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 (Nylon6/66) (CAS Reg. No. 24993-04-2).
Notifier: BASF Corporation
Manufacturer/Supplier: BASF Corporation
Intended Use: As the non-food contact layer in multi-layer films.
Limitations/Specifications: The multi-layer films containing the FCS may be used for single and repeated use in contact with all food for cook-in bag/packaging film applications at temperatures up to 400°F for 4h. The films will have a maximum thickness of 1 mil (0.001 inch) of the FCS. 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: Dec 12, 2012
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 208 kB)
FDA Decision: Finding of No Significant Impact (FONSI)