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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. 52

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: A high density agarose resin, crosslinked and alkylated with epichlorohydrin, followed by chemical binding of benzylamine. The agarose resin would be in the form of beads with a particle size of 100 to 300 um for not less than 90% of the particles.
Notifier: Chr. Hansen A/S
Manufacturer: UpFront Chromatography A/S
Intended Use: As a chromatographic material for the isolation and purification of food enzymes.
Limitations/Specifications*: For use only in contact with aqueous food enzyme solutions. The resins shall be used and stored (long term storage) at pH values that do not exceed 12. The water, buffers, and food passing through the resins shall have temperatures that do not exceed 30°C and linear flow rates that are not less than 150 centimeters/hour. The resins must comply with the applicable limitations for ion exchange resins in 21 CFR 173.25(c).
Effective Date: Aug 2, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (124 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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