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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. 469

Lyckeby Stärkelsen Industrial Starches AB 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 by treatment with greater than 5 percent and not more than 21 percent by weight of 2,3-epoxypropyl trimethylammonium chloride (CAS Reg. No. 3303-77-0).
Notifier: Lyckeby Stärkelsen Industrial Starches AB Penford Products Company
Manufacturer: Lyckeby Stärkelsen Industrial Starches AB 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 Title 21 CFR 178.3520(a)(1), (b), and (c). The finished paper and paperboard may be used only under Conditions of Use A through D identified in Table 2.
Effective Date: Feb 25, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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