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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. 156

Invitrogen Corporation

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: Cellulose, regenerated polymer with epichlorohydrin, carboxymethyl 2-hydroxypropyl ether (CAS Reg. No. 343844-23-5). The FCS is also referred to as carboxymethyl (CM) ion exchange cellulose resin.
Notifier: Invitrogen Corporation
Manufacturer: Invitrogen Corporation
Intended Use: The CM ion exchange cellulose resin is used to isolate and purify soluble protein from aqueous process streams for food processing.
Limitations/Specifications*: The temperature of water and food passing through the CM ion exchange cellulose resin should not exceed 40°C. The operating pH of the column is between a pH of 2 and 10. The columns should be washed and preconditioned prior to use according to the manufacturers specifications as described in detail in the notification.
Effective Date: Sep 4, 2001
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo