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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. 1787

BASF SE

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 SE
Manufacturer/Supplier: BASF SE
Intended Use: As a component in multi-layer films intended to contact food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The multi-layer films containing the FCS may be used for single and repeated use in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2. The films will have a maximum thickness of 2 mil (0.002 inch) of the FCS. Adjuvant substances permitted for use in Nylon 6/66 polymers may be used in the FCS, subject to any limitations regarding conditions of use, food types, or any other limitation in the authorizing regulation or notification. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jul 18, 2017
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1.2 MB)
FDA Decision: Finding of No Significant Impact (FONSI) and EA Revision Sheet

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