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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. 528

UpFront Chromatography A/S

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: Agarose, cross-linked with epichlorohydrin and derivatized with 1,4-butane sultone, supported on tungsten carbide beads.
Notifier: UpFront Chromatography A/S
Manufacturer/Supplier: UpFront Chromatography A/S
Intended Use: As an ion exchange resin for adsorption of proteins from skim milk and whey.
Limitations/Specifications: For repeat use only. The diameter of the agarose beads is less than 250 um, and the diameter of the tungsten carbide solid inner core of the beads is between 10-30 um. The whey or skim milk should be adjusted to a pH range of 5.5-7.5 and a temperature range of 5-55°C before passing through the beads at a linear flow rate of 600-3000 cm/hr. The milk protein adsorbed by the FCS may be used widely in all food and feed applications.
Effective Date: Nov 15, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo