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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. 355

E.I. duPont de Nemours and Company

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: 1,3-benzenedicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, sodium salt, polymer with dimethyl 1,4-benzenedicarboxylate, dimethyl pentanedioate, poly(ethylene glycol), and 1,2-ethanediol.
Notifier: E.I. duPont de Nemours and Company
Manufacturer/Supplier: E.I. duPont de Nemours and Company
Intended Use: As a coating or film.
Limitations/Specifications: The coating or film shall have a maximum thickness of 4 mils (0.004 inches) to fabricate food-contact articles in contact with 1) Food Types I, II, III, IV, VI-B, and VII for use up to 85°C for up to 15 minutes, up to 66°C for up to 30 minutes, or up to 40°C for up to 2 hours, 2) Food Type V and IX under Conditions of Use D through G, and 3) Food Type VIII under Conditions of Use A through H. Food Types and Conditions of Use are set forth in Tables 1 and 2, respectively.
Effective Date: Dec 27, 2003
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 922 kB)
FDA Decision: Finding of No Significant Impact (FONSI)