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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. 1752

Unitika Ltd.

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: 2,5-Furandione, polymer with ethene, ester with ethenol homopolymer (CAS Reg. No. 76930-37-5).
Notifier: Unitika Ltd.
Manufacturer/Supplier: Unitika Ltd.
Intended Use: As a barrier coating on Nylon 6 film, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use at a thickness of 0.1 to 0.5 micrometers. The FCS may be used in contact with food types I, II, III, IV, V, VIB, VII, VIII, and IX under Conditions of Use A through H, as described in Tables 1 and 2. Coatings containing the FCS will be applied to Nylon 6 films. The Nylon 6 film will comply with FDA regulations for the intended use. 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 24, 2017
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo