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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. 681

Grain Processing 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: 3-Chloro-2-hydroxypropyltrimethylammonium chloride (CAS Reg. No. 3327-22-8).
Notifier: Grain Processing Corporation
Manufacturer: Grain Processing Corporation
Intended Use: For use as a starting material in the production of 2,3-epoxypropyltrimethylammonium chloride (EPTAC) (CAS Reg. No. 3033-77-0) that will be used to modify industrial starch at a treatment level of greater than 5 percent and not more than 21 percent by weight of the starch to form high cationic starch (HCS). The finished HCS is intended for use as a retention aid and/or drainage aid and/or dry-strength agent employed prior to the sheet forming operation in the manufacture of all food-contact paper and paperboard.
Limitations/Specifications*: Paper or paperboard containing the finished HCS may contact all types of food, at use levels not to exceed 1 percent by weight of the paper or paperboard under Conditions of Use A through D, and at use levels not to exceed 2 percent by weight of the paper or paperboard under Conditions of Use E through H, as described in Table 2. The modified industrial starch must be used in compliance with 21 CFR 178.3520(a)(1), (b) and (c).
Effective Date: Feb 28, 2007
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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