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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. 2002

Flexpur Polímeros de Poliuretano, S.A.

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: Polyurethane resin produced by reacting a mixture of 2,4-toluene diisocyanate (CAS Reg. No. 584-84-9) and 2,6-toluene diisocyanate (CAS Reg. No. 91-08-7) with polyoxyethylene-polyoxypropylene glyceryl ether (CAS Reg. No. 9082-00-2) and 1,4-butanediol (CAS Reg. No. 110-63-4).
Notifier: Flexpur Polímeros de Poliuretano, S.A.
Manufacturer/Supplier: Flexpur Polímeros de Poliuretano, S.A.
Intended Use: As a binder or adhesive in the manufacture of agglomerated cork stoppers that contact alcoholic beverages. The stoppers will function as closures for alcoholic beverage containers, i.e., Food Types VI-A and VI-C, under Conditions of Use D through G, as described in Tables 1 and 2.
Limitations/Specifications: For use at levels not to exceed 33% by weight of finished agglomerated stoppers.
Effective Date: Oct 3, 2019
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 651 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 134 kB)

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