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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. 1685

Purolite Corporation
Purolite S.R.L.

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: Copolymer of glycidyl methacrylate and ethylene glycol dimethacrylate with 1,6-diaminohexane or ethylenediamine.
Notifier: Purolite Corporation
Manufacturer/Supplier: Purolite Corporation
Purolite S.R.L.
Intended Use: As a solid support for the ionic immobilization of enzyme preparations used in the production of wheat and corn-based sweeteners, sugar solutions, and artificial sweeteners, except for use in contact with infant formula or ingredients used for making infant formula (see Limitations/Specifications).
Limitations/Specifications: The FCS is intended for use in repeat-use applications. The FCS is not for use in contact with infant formula and ingredients for making infant formula. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jan 13, 2017
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 521 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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