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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. 1352

Celanese, 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: Vinyl acetate polymers modified by glycidyl methacrylate and/or ethylene.
Notifier: Celanese, Ltd.
Manufacturer/Supplier: Celanese, Ltd.
Intended Use: The FCS is intended for use as a pigment binder in food-contact paper and paperboard for all food types under all Conditions of Use, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used at a maximum level of 6.5% by weight of the finished food-contact paper or paperboard. The FCS may contain up to 5% total polymer units derived from glycidyl methacrylate and up to 20% total polymer units derived from ethylene. The safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Feb 18, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo