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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. 1227

Siam Quality Starch Co., Ltd.

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 2,3-epoxypropyltrimethylammonium chloride (CAS Reg. No. 56780-58-6).
Notifier: Siam Quality Starch Co., Ltd.
Manufacturer: Siam Quality Starch Co., Ltd.
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 will 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% by weight of the dry pulp when used in the manufacture of paper and paperboard intended to contact all food types under Condition of Use E (″Room temperature filled and stored (no thermal treatment in the container)″) through H (″Frozen or refrigerated storage: Ready prepared foods intended to be reheated in container at time of use″). In addition, the FCS may be added to the manufacturing process at a maximum level of 1% by weight of the dry pulp when used in the manufacture of paper and paperboard that is intended for use in contact with all food types under Conditions of Use A (″High temperature heat-sterilized (e.g., over 212oF″) through H, as described in Appendix V, Tables 1 and 2.
Effective Date: Dec 29, 2012
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo
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