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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. 735

Dichtungs-und Maschinenhandelsges.m.b.H.

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: A thermoplastic polyurethane formulated from 1,6-hexanediolpolycarbonate (CAS Reg. No. 101325-00-2), 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8) and 2,2'-p-phenylenedioxydiethanol (CAS Reg. No. 104-38-1).
Notifier: Dichtungs-und Maschinenhandelsges.m.b.H.
Manufacturer/Supplier: Dichtungs-und Maschinenhandelsges.m.b.H.
Intended Use: The FCS is a special-shaped molded ring (seal) that prevents processed food from contacting other moving parts of machinery (e.g., pistons, rods, etc.).
Limitations/Specifications: For repeat use as a molded article (seal) in single use applications under conditions of use B through H with all food types except VI-A and VI-C inTables 1 and 2.
Effective Date: Aug 24, 2007
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo