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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. 850

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: To be used as a modifier in food contact materials fabricated from ethylene-vinyl acetate-vinyl alcohol copolymer (EVOH), complying with 21 CFR 177.1360(a)(3).
Limitations/Specifications: The FCS will not exceed 35 percent by weight in the polymer blend. The EVOH/FCS blend may also contain optional adjuvant substances permitted for such use under 21 CFR 170 through 179. Food contact materials containing the FCS will not exceed 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.
Effective Date: Dec 31, 2008
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 176 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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