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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. 1534

EMS-Chemie AG

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 azacyclotridecan-2-one, 1,4-benzenedicarboxylic acid and 4,4'-methylenebis[2-methylcyclohexanamine] (CAS Reg. No. 62694-40-0)
Notifier: EMS-Chemie AG
Manufacturer/Supplier: EMS-Chemie AG
Intended Use: For use in repeat-use food-contact articles, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: For use in contact with all food types under Conditions of Use A through H and J, as described in Tables 1 and 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 in the authorizing regulation or notification. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: May 26, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

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