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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. 12

Lyckeby Starkelsen Industrial Starches AB

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% and not more than 21% by weight 2,3-epoxypropyl trimethylammonium chloride (CAS Reg. No. 3033-77-0)
Notifier: Sveriges Starkelse- producenter
Manufacturer/Supplier: Lyckeby Starkelsen Industrial Starches AB
Intended Use: 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 food-contact paper and paperboard
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 shall be used only under conditions of use E through H identified in Table 2.
Effective Date: Mar 31, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)
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