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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. 512

Penford Products Company

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-epoxypropyl trimethylammonium chloride (CAS Reg. No. 3033-77-0).
Notifier: Penford Products Company
Manufacturer: Penford Products Company
Intended 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 food-contact paper and paperboard at a maximum level of 1 percent by weight of the dry pulp.
Limitations/Specifications*: The modified industrial starch must be used in compliance with 21 CFR 178.3520(a)(1), (b) and (c). The finished paper and paperboard may be used only under Conditions of Use A through H identified in Table 2.
Effective Date: Oct 8, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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