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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. 1630

ZEON Corporation
ZEON Chemicals (Thailand) Co., Ltd.

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: Cyclopentene, polymer with 1-butene, (2E)-2-butene, (2Z)-2-butene, 2-methyl-1-propene, and 1,3-pentadiene (CAS Reg. No. 220543-67-9).
Notifier: ZEON Corporation
Manufacturer/Supplier: ZEON Corporation
ZEON Chemicals (Thailand) Co., Ltd.
Intended Use: As a component of can-end cements as described in 21 C.F.R. 175.300(b)(3)(xxxi), except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: For use at levels not to exceed 12% by weight of dry can-end cements for contact with all food types under Conditions of Use A through H and J, as described in Table 2. 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 12, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo