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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. 1393

Goulston Technologies, Inc.

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: Amines, C10-C18-alkyldimethyl, N-oxides.
Notifier: Goulston Technologies, Inc.
Manufacturer/Supplier: Goulston Technologies, Inc.
Intended Use: As an anti-static agent for topical treatments over the surface of a polystyrene (PS) or polyester polymer film or sheet for use in contact with food, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be applied at levels up to 2.5 mg/m2 (1.6 μg/in2) for PS and 0.75 mg/m2 (0.5 μg/in2) for polyester. Articles made from the FCS may be used for packaging in contact with the food types and conditions of use permitted for the PS or polyester. The safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Mar 19, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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