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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. 526

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 1,3-benzenedimethanamine and hexanedioic acid (CAS Reg. No. 28628-75-3). REPLACES FCN #472
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 for packaging.
Limitations/Specifications: Not to exceed 25 um in thickness in contact with all food types under Conditions of Use A through H as described in Table 2. The FCS will be separated from food by one or more polymeric layers, not including low density polyethylene (LDPE), having a total thickness of at least 8 um. 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: Oct 5, 2005
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 384 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement