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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. 439

Roquette Frères

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 2,3-epoxypropyltrimethyl-ammonium chloride (CAS Reg. No. 56780-58-6).
Notifier: Roquette Frères
Manufacturer: Roquette Frères
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 FCS may be added to the paper manufacturing process at a maximum level of 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, identified in Table 2. In addition, the FCS may be added to the manufacturing process of finished paper and paperboard that is intended for use in contact with all food types under Conditions of Use A through D (identified in Table 2), provided that it is added to the manufacturing process of paper and paperboard made from recycled, food-contact paper and paperboard and that the level used does not exceed 1 percent by weight of dry pulp.
Effective Date: Oct 27, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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