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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. 72

Indorama Ventures USA Inc. 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: Ethylene terephthalate-isophthalate copolymers.
Notifier: Indorama Ventures USA Inc. and its stewarded affiliates around the world.
Manufacturer: Indorama Ventures USA Inc. and its stewarded affiliates around the world.
Intended Use: As the base sheet in the manufacture of repeat-use food-contact articles intended to contact aqueous, acidic and low-alcohol food at temperatures 49°C.
Limitations/Specifications*: The FCS is manufactured from ethylene glycol, dimethyl terephthalate, and isophthalate acid and the finished polymer shall contain at least 88 weight percent of polymer units derived from ethylene terephthalate and must meet specifications in 21 CFR 177.1630 appropriate to its intended use.
Effective Date: Aug 10, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (137 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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