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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. 314

Solenis LLC

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: 2-Propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No. 464178-90-3).
Notifier: Hercules, Inc.
Manufacturer/Supplier: Solenis LLC
Intended Use: As an oil/grease resistant sizing agent employed prior to the sheet-forming operation in the manufacture of paper and paperboard for single use applications.
Limitations/Specifications: The FCS may be used at a level not to exceed 0.5 percent by weight of the dry paper and paperboard intended for use in contact with all food types (I-IX), under Conditions of Use B through H as described in Tables 1 and 2, respectively. The FCS may also be used in accordance with food additive regulations and effective notifications which incorporate by reference materials cleared in 21 CFR 176.170 and 176.180.
Effective Date: Apr 23, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo