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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. 417

EMS-Chemie AG/EMS Chemie (North America) Inc.

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: 1,3-benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,6-hexanediamine and 4,4'-methylenebis[2-methylcyclohexanamine] (CAS Reg. No. 112754-95-7).
Notifier: EMS-Chemie AG/EMS Chemie (North America) Inc.
Manufacturer/Supplier: EMS-Chemie AG/EMS Chemie (North America) Inc.
Intended Use: As a component of non-food-contact layers of multilayer films.
Limitations/Specifications: The thickness of the FCS component of the non-food-contact layer will not exceed 25 um and will be separated from food by one or more polymeric layers having a total thickness of at least 8 um. For use in contact with all foods under conditions of use B 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: Jul 30, 2004
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 394 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement