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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. 635

Alpek S.A.B. de C.V. and its stewarded affiliates around the world

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 copolyesters (diethylene glycol-isophthalate modified) prepared by the condensation of dimethyl terephthalate or terephthalic acid with ethylene glycol and with one or more of the following: dimethyl isophthalate, isophthalic acid, and diethylene glycol. The finished polymer shall contain a total of not more than 10 mole-percent of diethylene glycol and isophthalate units, with the diethylene glycol content expressed as a mole-percent of the total glycol units and the isophthalate content expressed as a mole-percent of the total isophthalate/terephthalate units.
Notifier: DAK Americas, LLC
Manufacturer/Supplier: Alpek S.A.B. de C.V. and its stewarded affiliates around the world
Intended Use: For use as films or articles intended for contact with aqueous, acidic, low-alcohol (up to 15 percent alcohol), and fatty foods under Conditions of Use A through H as described in Table 2, and for use in contact with high-alcohol foods under Conditions of Use E through G as described in Table 2.
Limitations/Specifications: The finished food-contact film or article must meet any applicable specifications and is subject to all applicable Conditions of Use cited in Title 21 CFR 177.1630(f), (g), and/or (j).
Effective Date: Aug 30, 2006
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 482 kB)
FDA Decision: Finding of No Significant Impact (FONSI)