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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. 844

Toyobo 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: Copolyester of 1,4-benzene dicarboxylic acid polymer with 1,4-butanediol, (E)-2-butenedioic acid, 1,2-ethanediol, and 1,6-hexanedioic acid grafted with styrene-maleate copolymer.
Notifier: Toyobo Co., Ltd.
Manufacturer: Toyobo Co., Ltd.
Intended Use: As an adhesion aid for Nylon 6 and Nylon 6 modified with Nylon MXD-6.
Limitations/Specifications*: The FCS may be used as a non-food contact layer not to exceed 0.12 micrometers thickness separated from food by a minimum of 100 micrometers thick polypropylene. Laminates utilizing the FCS are intended for use in contact with fatty foods (food types III, IVA, V, VIIA and IX) under Conditions of Use A through H as described in Tables 1 and 2.
Effective Date: Dec 3, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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