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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. 2130

Sekisui Specialty Chemicals America, 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: Acetic acid ethenyl ester, polymer with N-ethenylformamide, hydrolyzed, amine-containing (CAS Reg. No. 163879-68-3).
Notifier: Sekisui Specialty Chemicals America, LLC
Manufacturer/Supplier: Sekisui Specialty Chemicals America, LLC
Intended Use: For use as a creping agent in the manufacture of paper, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at levels not to exceed 25.8 µg/in2 of paper in contact with all food types under Conditions of Use A through H as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jun 16, 2021
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 75 kB)
FDA Decision: Finding of No Significant Impact (FONSI) & EA Revision Sheet (in PDF, 138 kB)

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