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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. 964

Western Polymer 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: Industrial starch modified (CAS Reg. No. 56780-58-6) by treatment with greater than 5 percent and not more than 21 percent by weight 2,3-epoxypropyltrimethylammonium chloride (CAS Reg. No. 3033-77-0).
Notifier: Western Polymer Corporation
Manufacturer: Western Polymer Corporation
Intended Use: As a retention aid, drainage aid, and/or dry-strength agent employed prior to the sheet forming operation in the manufacture of food-contact paper and paperboard.
Limitations/Specifications*: The modified industrial starch must be used in compliance with 21 CFR 178.3520 (b) and (c). The FCS may be used at a level not to exceed 2 percent by weight of the dry pulp when intended for use with paper and paperboard that will contact all food types under Conditions of Use E through H. Or, the FCS may be used at a level not to exceed 1 percent by weight of the dry pulp when intended for use with paper and paperboard that will contact with all food types under Conditions of Use A through H as described in Tables 1 and 2.
Effective Date: May 11, 2010
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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