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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. 360

DuPont Teijin Films

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: Polyethylene terephthalate copolymers (diethylene glycol-azelaic acid modified) prepared by the condensation of terephthalate acid (or dimethyl terephthalate) and ethylene glycol with azelaic acid and diethylene glycol. The copolymers shall be manufactured and characterized as described in the notification.
Notifier: DuPont Teijin Films
Manufacturer/Supplier: DuPont Teijin Films
Intended Use: For use as films intended for contact with all types of food under Conditions of Use A through H as described in Table 2, and in ovenable applications at temperatures up to 400°F.
Limitations/Specifications: The finished food-contact film must meet any applicable specifications, and is subject to all applicable Conditions of Use cited in title 21 CFR 177.1630(f), (g), (h) and/or (j). Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1630, may be used in the copolyesters that are the subject of this notification, subject to any limitations in the authorizing regulation.
Effective Date: Nov 20, 2003
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 350 kB)
FDA Decision: Finding of No Significant Impact (FONSI)