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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. 1439

Evonik Industries 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: Decanedioic acid, polymer with 1,10-decanediamine (CAS Reg. No. 27815-37-8).
Notifier: PSI.cube
Manufacturer/Supplier: Evonik Industries AG
Intended Use: As a basic polymer used in the production of articles intended to contact food, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used in contact with all types of food under Conditions of Use E through G, as described in Tables 1 and 2. The FCS may also be used in contact with all types of food in repeat use applications up to 100 °C. 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. Adjuvant substances permitted for use in nylon polymers complying with 21 CFR 177.1500 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.
Effective Date: Sep 24, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 542 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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