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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. 498

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: Polyethylene terephthalate copolyesters (including isophthalic acid and/or diethylene glycol modified) that otherwise comply with 21 CFR 177.1630 or an applicable effective Food Contact Notification, containing up to 0.85 weight percent sodium dimethyl 5-sulfoisophthalate units.
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: The FCS is intended for use as films or articles intended to contact food.
Limitations/Specifications*: The finished food-contact material containing the FCS may be used in contact with food types I, II, IVB, VI (containing up to 15 percent alcohol), VIIB, and VIII, under Conditions of Use C through G, as described in Tables 1 and 2, respectively. 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 applicable limitations.
Effective Date: Jun 24, 2005
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (438 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement
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