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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. 197


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: Copolymers (polyurethanes) produced from 4,4'-methylenebis(cyclohexylisocyanate), polytetramethylene glycol, and polyethylene glycol (CAS Reg. No. 375387-19-2).
Notifier: UCB Films PLC
Manufacturer/Supplier: UCB Films PLC
Intended Use: As coatings on cellophane film.
Limitations/Specifications: The polymers may be applied at a maximum weight of 0.52 mg/in2 on cellophane films used in contact with aqueous, acidic, low alcohol (up to 15 percent alcohol), and dry foods under Conditions of Use E through G, as described in Table 2.
Effective Date: Mar 8, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo