Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 157
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: | 1. Cellulose, regenerated, polymer with epichlorohydrin, 2-(diethylamino) ethyl 2-hydroxypropyl ether, (CAS Reg. No. 343845-30-7) (High Capacity). The FCS is also referred to as diethylaminoethyl (DEAE) ion exchange cellulose resin (High Capacity). 2. Cellulose, regenerated, polymer with epichlorohydrin, 2-(diethylamino) ethyl ether, (CAS Reg. No. 343846-01-5) (Medium Capacity). The FCS is also referred to as diethylaminoethyl (DEAE) ion exchange cellulose resin (Medium Capacity). |
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| Notifier: | Invitrogen Corporation |
| Manufacturer/Supplier: | Invitrogen Corporation |
| Intended Use: | The DEAE ion exchange resins are used to isolate and purify soluble proteins from aqueous process streams for food processing. |
| Limitations/Specifications: | The temperature of water and food passing through the DEAE ion exchange cellulose resin (High and Medium Capacity) should not exceed 50°C. The operating pH of the columns are 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 13, 2001 |
| National Environmental Policy Act (NEPA)** Submission: | Categorical Exclusion 25.32(j) |
| FDA Decision: | Categorical Exclusion Memo |
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