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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. 1371

Zeon Corporation

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-butadiene, 2-methyl-, homopolymer, of cis-1,4-configuration, cyclized (CAS Reg. No. 68441-13-4).
Notifier: Zeon Corporation
Manufacturer/Supplier: Zeon Corporation
Intended Use: As a modifier for ethylene-vinyl acetate-vinyl alcohol (EVOH) copolymers complying with 21 CFR 177.1360(a)(3), except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will not exceed 27 percent by weight of the EVOH/FCS polymer blend. Food contact materials containing the FCS will not exceed 55 microns (2.2 mils) in thickness and may contact Food Types I, II, IV-B, VI-A, VI-B, VII-B, and VIII, under Conditions of Use C through G as described in Tables 1 and 2. The EVOH/FCS blend may also contain optional adjuvant substances permitted for such use complying with an applicable authorization. The safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Feb 25, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 96 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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