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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. 721

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)
Notifier: EMS-CHEMIE AG/EMS-CHEMIE (NORTH AMERICA) INC.
Manufacturer: EMS-CHEMIE AG/EMS-CHEMIE (NORTH AMERICA) INC.
Intended Use: For use as a component of non-food-contact layers of multilayer articles; the thickness of the FCS component of the non-food-contact layer will not exceed 85 µm and will be separated from food by one or more layers of PET having a total thickness of at least 85 µm.
Limitations/Specifications*: (1) In contact with all food types under all conditions of use as described in Tables 1 and 2. (2) Adjuvant substances permitted for use in nylon polymers complying with 21 CFR ยง177.1500 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: Aug 30, 2007
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (818 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement
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