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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. 731

BASF Aktiengesellschaft

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 [Nylon 6/66] (CAS Reg. No. 24993-04-2)
Notifier: BASF Aktiengesellschaft
Manufacturer: BASF Aktiengesellschaft
Intended Use: As a component of films intended to contact food.
Limitations/Specifications*: The FCS may be used in contact with all food types under Conditions of Use A through H and J (for dual-ovenable containers), as described inTables 1 and 2. The FCS may be used in cook-in-bag/packaging film applications and in multi-layer film applications at temperatures up to 375°F for 4 hours. 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: Aug 14, 2007
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (255 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement