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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. 659

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, bis(4-aminocyclohexyl)methane and 1,6-hexanediamine (Nylon 6/66/136) (CAS Reg. No. 25053-13-8).
Notifier: BASF Aktiengesellschaft
Manufacturer: BASF Aktiengesellschaft
Intended Use: The FCS is intended for use as a thin coating for food packaging materials, especially for plastic film and paper.
Limitations/Specifications*: The FCS will have a maximum thickness of 50 um and will be applied as a coating to food packaging materials contacting all food types under Conditions of Use A through H as described in Table 2. Adjuvant substances permitted for use in nylon polymers complying with 21 CFR 177.1500 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: Nov 22, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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